Psoriasis
Conditions
Keywords
Tuberculin Purified Protein Derivative, Delayed Type Hypersensitivity, Biopsy, Induration, First time in human, T-cells, LAG-3, safety, GSK2831781, psoriasis
Brief summary
This study is a phase I, randomised, double blind (sponsor unblinded), placebo-controlled, single ascending dose study GSK2831781 administered by IV. GSK2831781 is a humanized Antibody Dependent Cell Cytotoxicity (ADCC) enhanced monoclonal afucosylated antibody that is specific to the Lymphocyte Activation Gene-3 (LAG-3) protein. This is the first administration of GSK2831781 in humans and will evaluate in two parts the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of single IV doses of GSK2831781 administered to healthy subjects previously vaccinated with Bacillus Calmette Guérin (BCG) (Part A delayed type hypersensitivity \[DTH\] cohorts) and patients with plaque psoriasis (Part B). The inclusion of DTH and psoriasis subjects to explore the mechanism in biopsies and clinical response endpoints in these populations, as well as investigate systemic biomarkers will provide useful information prior to conducting studies in other immune-inflammatory disease which will involve more invasive tissue biopsies. Measuring the pharmacology of GSK2831781 using the depletion of LAG-3+ T-cells in skin biopsies from Tuberculin Purified Protein Derivative (PPD) skin challenge and lesional skin biopsies from patients with psoriasis, will be helpful in understanding of the dose response relationship, which will be important for designing future studies in immuno-inflammatory diseases, including psoriasis. Approximately 67 subjects will be enrolled to complete dosing and critical assessments. The subject numbers will be split to approximately 40 healthy subjects (Part A) and 27 patients with psoriasis (Part B).
Interventions
BIOLOGICALGSK2831781
GSK2831781 (100 milligram (mg)/mL) and its dilutions (Diluent - 0.9 percent saline solution containing 0.015 percent Polysorbate 80) as clear or opalescent, colourless, yellow to brown liquid solution administered by IV over approximately 2 hours.
BIOLOGICALPlacebo
Commercial saline solution administered by IV over approximately 2 hours
Sponsors
Parexel
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Part A males aged between 18 and 65 years of age and Part B males and females aged between 18 and 75 years of age inclusive, at the time of signing the informed consent * Part A: A body weight \<=120 kilogram (kg) and Body mass index (BMI) within the range 19-32 kg/square meter (m\^2) (inclusive), Part B: BMI within range 19-35 kg/m\^2 (inclusive). * Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin \<=1.5x Upper limit of normal (ULN) (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent) * Based on single or averaged Electrocardiogram QT interval corrected for heart rate (QTc) values of triplicate Electrocardiogram (ECGs) obtained over a brief recording period: Electrocardiogram QT interval corrected for heart rate using Fridericia's formula (QTcF) \<450 milliseconds (msec) * Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form For Part A study subjects only * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and 12-lead ECGs. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or
Exclusion criteria
, outside the reference range for the population being studied may be included only if the Investigator in consultation with the Glaxosmithkline (GSK) Medical Monitor, if required, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures Delayed type hypersensitivity (DTH) cohorts only * Subjects with a history of Bacillus Calmette Guérin (BCG) vaccination as evidence by either: A BCG scar and verbal confirmation of BCG vaccination ; Or documented medical history of a BCG vaccination with or without a BCG scar * Subjects with a history of current vaccination for Tetanus, diphtheria, measles, pertussis, mumps and rubella For Part B study subjects only * Subject has psoriasis covering Body Surface Area (BSA) \>=3 percent as assessed at Screening and Day-1 * Subject has had a confirmed diagnosis of chronic plaque-type psoriasis (without recent documented flare within 30 days prior to screening) for at least 6 months * Subject has at least 2 stable plaques assessed at Screening and Day -1. One of a suitable size and in a site suitable for repeat biopsy, and one for index lesion Plaque Lesional Severity Score (PLSS) scoring. Both must have a PLSS lesional score of \>=2 for the induration component (moderate or above), \>=1 for erythema and scaling with a total score of \>=5. The biopsy lesion must not be on the face, groin or scalp and must be protected from the sun * A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin (hCG) test at screening and negative urine hCG test at Day -1 for Females of Reproductive Potential \[FRP\]), not lactating, and at least one of the given conditions applies: Non-reproductive potential defined as pre-menopausal females with a documented tubal ligation; or documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; or hysterectomy; or documented bilateral oophorectomy. Postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels)\]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. Reproductive potential and agrees to use a barrier method (male condom or female diaphragm) plus to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in FRP from 28 days prior to the first dose of study medication and until completion of the follow-up visit. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. The investigator or designee should remind the subjects of the need to comply with these requirements approximately monthly, either at study visits or by telephone call until the follow-up visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | Up to 307 days | Hematology parameters with PCI ranges: hematocrit (high: \>0.54 percentage of red blood cells), hemoglobin (high: \>180 grams per liter \[g/L\]), lymphocytes (low: \<0.8\*giga cells per liter \[10\^9/L\]), neutrophil count (low: \<1.5\*10\^9/L), platelet count (low: \<100\*10\^9/L and high: \>550\*10\^9/L), and while blood cell count (low: \<3\*10\^9/L and high: \>20\*10\^9/L) for healthy volunteers and psoriasis participants. Safety population consisted of all randomized participants who received at least one dose of study treatment. Only those participants for which at least one value of PCI was reported are summarized. |
| Number of Participants With Clinical Chemistry Abnormalities of PCI | Up to 307 days | Clinical chemistry parameters and their potential clinical concern values: albumin (low: \<30 millimoles per liter \[mmol/L\]), calcium (low: \<2 mmol/L, high: \>2.75 mmol/L), creatinine (high: \>44.2 mmol/L), glucose (low: \<3 mmol/L, high: \>9 mmol/L), magnesium (low: \<0.5 mmol/L, high: \>1.23 mmol/L), phosphorus (low: \<0.8 mmol/L, high: \>1.6 mmol/L), potassium (low: \<3 mmol/L, high: \>5.5 mmol/L), sodium (low: \<130 mmol/L, high: \>150 mmol/L), and total carbon dioxide (CO2) (low: \<18 mmol/L, high: \>32 mmol/L). Number of participants with clinical chemistry of PCI are presented. |
| Number of Participants With Vital Signs of PCI | Up to 307 days | Vital signs included heart rate, systolic and diastolic blood pressure and body temperature were performed with the participant in a semi-supine position after the participant had rested for at least 5 minutes. The PCI range for heart rate (low: \<40 beats per minute \[BPM\] and high: \>110 BPM), systolic blood pressure (low: \<85 and high: \>160 millimeter of mercury \[mmHg\]), diastolic blood pressure (low: \<45 mmHg and high: \>100 mmHg) and body temperature (low: \<35 degree Celsius and high: \>37.5 degree Celsius). Number of participants with vital signs of PCI are presented. |
| Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) of PCI | Up to 307 days | Triplicate ECG was measured in a semi-supine position after 5 minutes rest. A single 12-lead ECG was obtained by using an ECG machine that automatically calculates heart rate and measured PR, QRS, QT, and Fridericia's formula (QTcF) intervals. The PCI ranges for QTc Interval (high: \>450 millisecond \[msec\]), PR Interval (low: \<110 msec and high: \>220 msec) and QRS Interval (low: \<75 msec and high: \>110 msec). Number of participants with ECG values of PCI are presented. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 307 days | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect and other important medical events judged by the investigator that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. |
| Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Baseline, 6, 12, 24 and 48 hours post-dose | IL-6, IL-8, interferon-gamma and TNF alpha were assessed at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day 1, pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value. |
| Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 191 | Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented. |
| Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | 6, 12, 72, 168 hours, Day 15 and 29 | Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented. |
| Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | 6, 12, 72, 168 hours, Days 15, 29 and 43 | Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented. |
| Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57 and 85 | Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented. |
| Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 147 | Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented. |
| Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 219 | Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented. |
| Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 191 | Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented. |
| Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 307 | Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented. |
| Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 237 | Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented. |
| Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 277 | Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented. |
| Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 307 | Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC(0-t) for GSK2831781 0.5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| AUC(0-t) for GSK2831781 1.5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| AUC(0-t) for GSK2831781 5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Area Under the Concentration-time Curve From Zero (Pre-dose) to Week 4 (AUC[0-Week 4]) for GSK2831781 0.0003 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24 and 696 (Week 4) hours post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| AUC(0-Week 4) for GSK2831781 0.0015 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 696 (Week 4) hours post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| AUC(0-Week 4) for GSK2831781 0.0075 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15 and 29 (Week 4) post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| AUC(0-Week 4) for GSK2831781 0.04 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22 and 29 (Week 4) post-dose | Blood samples were collected at specified time point for GSK2831781 in plasma. |
| AUC(0-Week 4) for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22 and 29 (Week 4) post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| AUC(0-Week 4) for GSK2831781 0.5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22 and 29 (Week 4) post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| AUC(0-Week 4) for GSK2831781 1.5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22 and 29 (Week 4) post-dose | Blood samples were collected at specified time point for GSK2831781 in plasma. |
| AUC(0-Week 4) for GSK2831781 5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22 and 29 (Week 4) post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Percentage of AUC(0-infinity) Obtained by Extrapolation (%AUCex) for GSK2831781 0.0003 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| %AUCex for GSK2831781 0.0015 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| %AUCex for GSK2831781 0.0075 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| %AUCex for GSK2831781 0.04 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| %AUCex for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| %AUCex for GSK2831781 0.5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| %AUCex for GSK2831781 1.5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| %AUCex for GSK2831781 5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Maximum Observed Concentration (Cmax) for GSK2831781 0.0003 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Cmax for GSK2831781 0.0015 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Cmax for GSK2831781 0.0075 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Cmax for GSK2831781 0.04 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Cmax for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Cmax for GSK2831781 0.5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Cmax for GSK2831781 1.5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Cmax for GSK2831781 5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Time of Occurrence of Cmax (Tmax) for GSK2831781 0.0003 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Tmax for GSK2831781 0.0015 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Tmax for GSK2831781 0.0075 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Tmax for GSK2831781 0.04 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Tmax for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Tmax for GSK2831781 0.5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Tmax for GSK2831781 1.5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Tmax for GSK2831781 5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Time of Last Quantifiable Concentration (Tlast) for GSK2831781 0.0003 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Tlast for GSK2831781 0.0015 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Tlast for GSK2831781 0.0075 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Tlast for GSK2831781 0.04 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Tlast for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Tlast for GSK2831781 0.5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Tlast for GSK2831781 1.5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Tlast for GSK2831781 5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Systemic Clearance of Parent Drug (CL) for GSK2831781 0.0003 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| CL for GSK2831781 0.0015 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| CL for GSK2831781 0.0075 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| CL for GSK2831781 0.04 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| CL for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| CL for GSK2831781 0.5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| CL for GSK2831781 1.5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| CL for GSK2831781 5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Volume of Distribution at Steady State (Vss) for GSK2831781 0.0003 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Vss for GSK2831781 0.0015 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Vss for GSK2831781 0.0075 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Vss for GSK2831781 0.04 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Vss for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Vss for GSK2831781 0.5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Vss for GSK2831781 1.5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Vss for GSK2831781 5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Mean Residence Time (MRT) for GSK2831781 0.0003 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| MRT for GSK2831781 0.0015 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| MRT for GSK2831781 0.0075 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| MRT for GSK2831781 0.04 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| MRT for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| MRT for GSK2831781 0.5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| MRT for GSK2831781 1.5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| MRT for GSK2831781 5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Terminal Elimination Rate (Lambda z) for GSK2831781 0.0003 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Lambda z for GSK2831781 0.0015 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Lambda z for GSK2831781 0.0075 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Lambda z for GSK2831781 0.04 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Lambda z for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Lambda z for GSK2831781 0.5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Lambda z for GSK2831781 1.5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Lambda z for GSK2831781 5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Terminal Phase Half-life (t1/2) for GSK2831781 0.0003 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| t1/2 for GSK2831781 0.0015 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| t1/2 for GSK2831781 0.0075 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| t1/2 for GSK2831781 0.04 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| t1/2 for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| t1/2 for GSK2831781 0.5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| t1/2 for GSK2831781 1.5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| t1/2 for GSK2831781 5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Number of Participants With Positive ADAs to GSK2831781 in Healthy Volunteer Placebo | Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 191) | Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection. |
| Number of Participants With Positive ADAs to GSK2831781 0.0003 mg/kg (ADA-ve) | Pre-dose (Day 1), 168 hours, and follow-up (Day 29) | Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection. |
| Number of Participants With Positive ADAs to GSK2831781 0.0015 mg/kg (ADA-ve) | Pre-dose (Day 1), 168 hours, Days 29 and follow-up (Day 43) | Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection. |
| Number of Participants With Positive ADAs to GSK2831781 0.0075 mg/kg (ADA-ve) | Pre-dose (Day 1), 168 hours, Days 29 and follow-up (Day 85) | Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection. |
| Number of Participants With Positive ADAs to GSK2831781 0.04 mg/kg (ADA-ve) | Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 147) | Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection. |
| Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA-ve) | Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 219) | Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection. |
| Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA+ve) | Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 191) | Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection. |
| Number of Participants With Positive ADAs to GSK2831781 Placebo in Psoriasis Participants | Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 307) | Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection. |
| Number of Participants With Positive ADAs to GSK2831781 0.5 mg/kg | Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 237) | Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection. |
| Number of Participants With Positive ADAs to GSK2831781 1.5 mg/kg | Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 277) | Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection. |
| Number of Participants With Positive ADAs to GSK2831781 5 mg/kg | Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 307) | Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection. |
| Change From Baseline in Psoriasis Area Severity Index (PASI) Scores | Baseline, Days 15, 29, 43, 85 and 121 | PASI score was determined by evaluation of body surface area (BSA) covered by plaque psoriasis in 4 areas (head, upper extremities, trunk and lower extremities with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged from 0=No symptoms, 1=slight, 2=moderate, 3=marked and 4=very marked) of erythema, induration and scaling in each of the 4 areas. PASI score ranges from 0 (no psoriasis) to 72 (worse psoriasis). Final PASI=(sum of severity score for each area) \* (% body area affected score \* area score). Baseline was considered as the latest pre-dose assessment with a non-missing value for Day -1. Change from Baseline was calculated as post-Baseline value minus Baseline value. |
| Actual PASI Scores | Baseline, Days 15, 29, 43, 85 and 121 | PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head, upper extremities, trunk and lower extremities with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged from 0=No symptoms, 1=slight, 2=moderate, 3=marked and 4=very marked) of erythema, induration and scaling in each of the 4 areas. PASI score ranges from 0 (no psoriasis) to 72 (worse psoriasis). Final PASI=(sum of severity score for each area) \* (% body area affected score \* area score). |
| Change From Baseline in Physicians Global Assessment (PGA) Scores in Psoriasis Participants | Baseline, Days 15, 29, 43, 85 and 121 | A 7-point scoring system was used to measure the severity of psoriatic lesions over the whole body. The score 0 indicated as clear: no signs of psoriasis and 6 indicated as severe: very marked plaque elevation, scaling and erythema. Baseline was considered as the latest pre-dose assessment with a non-missing value for Day -1. Change from Baseline was calculated as post-Baseline value minus Baseline value. |
| Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | Baseline, Days 15, 29, 43, 85 and 121 | PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head, upper extremities, trunk and lower extremities with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged from 0=No symptoms, 1=slight, 2=moderate, 3=marked and 4=very marked) of erythema, induration and scaling in each of the 4 areas. PASI score ranges from 0 (no psoriasis) to 72 (worse psoriasis). Final PASI=(sum of severity score for each area) \* (% body area affected score \* area score). Baseline was considered as the latest pre-dose assessment with a non-missing value for Day -1. |
| Change From Baseline in Plaque Lesional Severity Score (PLSS) Scores for the Index Plaque | Baseline, Days 15, 29, 43, 85 and 121 | PLSS is a 0 to 12 point rating scale for lesions, calculated as the sum of the scores (ranging from 0 = no symptoms to 4 = very marked) for 3 symptoms: induration, erythema and scaling, measured by a qualified dermatologist. The PLSS score for the Index Plaque ranged from 0 to 12. The score 0 indicated no symptoms and 12 is the worst score. Baseline was considered as the latest pre-dose assessment with a non-missing value for Day -1. Change from Baseline was calculated as post-Baseline value minus Baseline value. A negative change from Baseline is an improvement in symptoms. |
| Absolute PLSS Scores for the Index Plaque | Baseline, Days 15, 29, 43, 85 and 121 | PLSS is a 0 to 12 point rating scale for lesions, calculated as the sum of the scores (ranging from 0 = no symptoms to 4 = very marked) for 3 symptoms: induration, erythema and scaling, measured by a qualified dermatologist. The PLSS score for the Index Plaque ranged from 0 to 12. The score 0 indicated no symptoms and 12 is the worst score. |
| Absolute PGA Scores in Psoriasis Participants | Baseline, Days 15, 29, 43, 85 and 121 | A 7-point scoring system was used to measure the severity of psoriatic lesions over the whole body. The score 0 indicated as clear: no signs of psoriasis and 6 indicated as severe: very marked plaque elevation, scaling and erythema. |
| Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose | Baseline, Days 4, 8, 15 and 22 post-dose | The induration diameter by challenge site is defined as the average of the two skin response test values (vertical and horizontal) at each challenge site. A challenge site is defined by skin response (SR) directionality (upper/lower) and SR laterality (left/right). Four categories considered were as follows: left upper, right upper, left lower and right lower. Baseline was considered as Day -26. Change from Baseline was calculated as post-Baseline value minus Baseline value. Data is presented for DTH participants. |
| Percentage of Participants in Each PGA Score Category | Baseline, Days 15, 29, 43, 85 and 121 | A 7-point scoring system was used to measure the severity of psoriatic lesions over the whole body. The score 0=clear, 1=almost clear, 2=mild, 3=mild to moderate, 4=moderate, 5=moderate to severe and 6=severe. |
| Duration of Induration in the Re-challenge for DTH | Up to 28 days post-dose | The duration of induration was the time (in days) to achieve an overall induration less than 6 mm from the time of the PPD re-challenge post-dose. Duration of induration was calculated as: PPD re-challenge post-dose up to the last available induration measurement. Data is presented for DTH participants. |
| Change From Baseline (PPD First Challenge) of Lymphocyte Activation Gene-3 (LAG-3)+ Cells in Biopsies of Re-challenged Skin at 3 Days Post-dose | Baseline and 72 hours post-dose | A punch biopsy was taken from one of the challenge sites. Cells in biopsies of re-challenged skin were measured by immunohistochemistry (IHC) and the LAG-3+ cells characterized and counted. Baseline was considered as Day -26 for this outcome measure. Change from Baseline was calculated as post-Baseline value minus Baseline value. Data is presented for DTH participants. |
| Change From Baseline in LAG-3+ Cells in Lesional Biopsies in Psoriasis Participants at Day 29 | Baseline and Day 29 | A punch biopsy was taken from active leading edge of the lesion. Cells in lesional biopsies of skin were measured by IHC and count the LAG-3+ cells. The regions of interest for LAG3+ were located in epidermis and dermis. Baseline was considered as the latest pre-dose assessment with a non-missing value for Day -1. Change from Baseline was calculated as post-Baseline value minus Baseline value. |
| Area Under the Plasma Time Curve From Zero to Infinity (AUC[0-infinity]) of GSK2831781 0.0003 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. Pharmacokinetic (PK) population consisted of all participants in the Safety Population who had at least 1 non-missing PK assessment. |
| AUC(0-infinity) for GSK2831781 0.0015 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| AUC(0-infinity) for GSK2831781 0.0075 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| AUC(0-infinity) for GSK2831781 0.04 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| AUC(0-infinity) for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| AUC(0-infinity) for GSK2831781 0.5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| AUC(0-infinity) for GSK2831781 1.5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| AUC(0-infinity) for GSK2831781 5 mg/kg | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-t]) for GSK2831781 0.0003 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| AUC(0-t) for GSK2831781 0.0015 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| AUC(0-t) for GSK2831781 0.0075 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| AUC(0-t) for GSK2831781 0.04 mg/kg (ADA-ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
| AUC(0-t) for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve) | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose | Blood samples were collected at specified time points for GSK2831781 in plasma. |
Countries
Germany, United Kingdom
Participant flow
Recruitment details
This is a single ascending dose study conducted in healthy volunteers and participants with plaque psoriasis. Participants were enrolled in Germany and the United Kingdom from 30 July 2014 to 07 March 2018.
Pre-assignment details
A total of 330 participants were screened in healthy volunteer cohorts and 197 participants in psoriasis cohorts of which 290 were screen failures in healthy volunteer cohorts and 170 in psoriasis cohorts. A total of 40 participants were enrolled in healthy cohorts and 27 in psoriasis cohorts.
Participants by arm
| Arm | Count |
|---|---|
| Placebo for Healthy Volunteer Combined Healthy volunteers with no DTH and with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start. | 14 |
| GSK2831781 0.0003 mg/kg (ADA-ve) Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start. | 1 |
| GSK2831781 0.0015 mg/kg (ADA-ve) Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start. | 1 |
| GSK2831781 0.0075 mg/kg (ADA-ve) Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start. | 6 |
| GSK2831781 0.04 mg/kg (ADA-ve) Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start. | 6 |
| GSK2831781 0.15 mg/kg (ADA-ve) Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29. | 6 |
| GSK2831781 0.15 mg/kg (ADA+ve) Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start. | 6 |
| Placebo for Psoriasis Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start. | 9 |
| GSK2831781 0.5 mg/kg Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start. | 6 |
| GSK2831781 1.5 mg/kg Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start. | 6 |
| GSK2831781 5 mg/kg Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start. | 6 |
| Total | 67 |
Baseline characteristics
| Characteristic | GSK2831781 0.15 mg/kg (ADA+ve) | Placebo for Psoriasis | GSK2831781 0.5 mg/kg | GSK2831781 1.5 mg/kg | GSK2831781 5 mg/kg | Total | Placebo for Healthy Volunteer Combined | GSK2831781 0.0003 mg/kg (ADA-ve) | GSK2831781 0.0015 mg/kg (ADA-ve) | GSK2831781 0.0075 mg/kg (ADA-ve) | GSK2831781 0.04 mg/kg (ADA-ve) | GSK2831781 0.15 mg/kg (ADA-ve) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 8 Participants | 6 Participants | 6 Participants | 6 Participants | 66 Participants | 14 Participants | 1 Participants | 1 Participants | 6 Participants | 6 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 6 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European heritage | 6 Participants | 9 Participants | 6 Participants | 6 Participants | 6 Participants | 61 Participants | 12 Participants | 1 Participants | 1 Participants | 5 Participants | 5 Participants | 4 Participants |
| Sex: Female, Male Female | 0 Participants | 4 Participants | 0 Participants | 1 Participants | 1 Participants | 6 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 6 Participants | 5 Participants | 5 Participants | 61 Participants | 14 Participants | 1 Participants | 1 Participants | 6 Participants | 6 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 1 | 0 / 1 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 9 | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 8 / 14 | 0 / 1 | 0 / 1 | 5 / 6 | 6 / 6 | 3 / 6 | 3 / 6 | 9 / 9 | 4 / 6 | 6 / 6 | 6 / 6 |
| serious Total, serious adverse events | 0 / 14 | 0 / 1 | 0 / 1 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 9 | 0 / 6 | 0 / 6 | 1 / 6 |
Outcome results
Primary
Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha
IL-6, IL-8, interferon-gamma and TNF alpha were assessed at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day 1, pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Time frame: Baseline, 6, 12, 24 and 48 hours post-dose
Population: Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 6 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 1.284 Picogram per milliliter (pg/mL) | Standard Deviation 2.7802 |
| Placebo for Healthy Volunteer Combined | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 3.748 Picogram per milliliter (pg/mL) | Standard Deviation 5.0647 |
| Placebo for Healthy Volunteer Combined | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 0.727 Picogram per milliliter (pg/mL) | Standard Deviation 1.5514 |
| Placebo for Healthy Volunteer Combined | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 1.887 Picogram per milliliter (pg/mL) | Standard Deviation 4.1642 |
| Placebo for Healthy Volunteer Combined | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 6 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 2.889 Picogram per milliliter (pg/mL) | Standard Deviation 5.5511 |
| Placebo for Healthy Volunteer Combined | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 4.344 Picogram per milliliter (pg/mL) | Standard Deviation 5.4602 |
| Placebo for Healthy Volunteer Combined | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 6.402 Picogram per milliliter (pg/mL) | Standard Deviation 21.1483 |
| Placebo for Healthy Volunteer Combined | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 1.337 Picogram per milliliter (pg/mL) | Standard Deviation 9.4965 |
| Placebo for Healthy Volunteer Combined | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:6hours(n=14, 1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| Placebo for Healthy Volunteer Combined | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:12hours(n=13,1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| Placebo for Healthy Volunteer Combined | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:24hours(n=14,1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| Placebo for Healthy Volunteer Combined | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:48hours(n=12,1,1,6,6,6,5,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| Placebo for Healthy Volunteer Combined | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha:6hours (n=14,1,1,6,6,6,6,9,6,6,6) | 0.166 Picogram per milliliter (pg/mL) | Standard Deviation 1.1347 |
| Placebo for Healthy Volunteer Combined | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | -0.201 Picogram per milliliter (pg/mL) | Standard Deviation 1.3961 |
| Placebo for Healthy Volunteer Combined | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | -0.244 Picogram per milliliter (pg/mL) | Standard Deviation 1.4101 |
| Placebo for Healthy Volunteer Combined | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | -0.366 Picogram per milliliter (pg/mL) | Standard Deviation 1.239 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 0.420 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 1.800 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 6 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 1.430 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | -0.450 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 1.720 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | -1.030 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha:6hours (n=14,1,1,6,6,6,6,9,6,6,6) | 0.050 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:48hours(n=12,1,1,6,6,6,5,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:24hours(n=14,1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 7.630 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:12hours(n=13,1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:6hours(n=14, 1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 47.900 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 2.100 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 6 hours (n=14,1,1,6,6,6,6,9,6,6,6) | -0.100 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 7.140 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:24hours(n=14,1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 2.760 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | -0.740 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 6 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 0.000 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 6 hours (n=14,1,1,6,6,6,6,9,6,6,6) | -0.210 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 0.310 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 0.000 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:12hours(n=13,1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 0.000 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 0.000 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 0.700 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | -0.480 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha:6hours (n=14,1,1,6,6,6,6,9,6,6,6) | 1.940 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:6hours(n=14, 1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:48hours(n=12,1,1,6,6,6,5,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | -0.260 Picogram per milliliter (pg/mL) | — |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | -1.493 Picogram per milliliter (pg/mL) | Standard Deviation 3.6579 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | -1.272 Picogram per milliliter (pg/mL) | Standard Deviation 3.1149 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 6 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 4.302 Picogram per milliliter (pg/mL) | Standard Deviation 2.7723 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 5.487 Picogram per milliliter (pg/mL) | Standard Deviation 5.5182 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 0.560 Picogram per milliliter (pg/mL) | Standard Deviation 2.2738 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 0.028 Picogram per milliliter (pg/mL) | Standard Deviation 0.0694 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 0.810 Picogram per milliliter (pg/mL) | Standard Deviation 1.5676 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:6hours(n=14, 1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:12hours(n=13,1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:24hours(n=14,1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:48hours(n=12,1,1,6,6,6,5,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha:6hours (n=14,1,1,6,6,6,6,9,6,6,6) | 4.958 Picogram per milliliter (pg/mL) | Standard Deviation 3.808 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 5.075 Picogram per milliliter (pg/mL) | Standard Deviation 2.8043 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 2.650 Picogram per milliliter (pg/mL) | Standard Deviation 1.2128 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 6 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 0.258 Picogram per milliliter (pg/mL) | Standard Deviation 1.8234 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 0.127 Picogram per milliliter (pg/mL) | Standard Deviation 3.2387 |
| GSK2831781 0.04 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 0.878 Picogram per milliliter (pg/mL) | Standard Deviation 0.8027 |
| GSK2831781 0.04 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | -0.212 Picogram per milliliter (pg/mL) | Standard Deviation 2.1383 |
| GSK2831781 0.04 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 6.735 Picogram per milliliter (pg/mL) | Standard Deviation 3.9483 |
| GSK2831781 0.04 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:6hours(n=14, 1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| GSK2831781 0.04 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:24hours(n=14,1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| GSK2831781 0.04 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 5.935 Picogram per milliliter (pg/mL) | Standard Deviation 3.4483 |
| GSK2831781 0.04 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 4.780 Picogram per milliliter (pg/mL) | Standard Deviation 10.3055 |
| GSK2831781 0.04 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:12hours(n=13,1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| GSK2831781 0.04 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha:6hours (n=14,1,1,6,6,6,6,9,6,6,6) | 3.047 Picogram per milliliter (pg/mL) | Standard Deviation 5.0083 |
| GSK2831781 0.04 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:48hours(n=12,1,1,6,6,6,5,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| GSK2831781 0.04 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 6 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 1.025 Picogram per milliliter (pg/mL) | Standard Deviation 1.6945 |
| GSK2831781 0.04 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 5.107 Picogram per milliliter (pg/mL) | Standard Deviation 3.1582 |
| GSK2831781 0.04 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 6.408 Picogram per milliliter (pg/mL) | Standard Deviation 11.0052 |
| GSK2831781 0.04 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 0.522 Picogram per milliliter (pg/mL) | Standard Deviation 1.2778 |
| GSK2831781 0.04 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 6 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 1.752 Picogram per milliliter (pg/mL) | Standard Deviation 3.0055 |
| GSK2831781 0.04 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 0.000 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| GSK2831781 0.15 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 6 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 4.305 Picogram per milliliter (pg/mL) | Standard Deviation 5.0046 |
| GSK2831781 0.15 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha:6hours (n=14,1,1,6,6,6,6,9,6,6,6) | 5.162 Picogram per milliliter (pg/mL) | Standard Deviation 4.6045 |
| GSK2831781 0.15 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 6 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 3.657 Picogram per milliliter (pg/mL) | Standard Deviation 4.9829 |
| GSK2831781 0.15 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | -0.425 Picogram per milliliter (pg/mL) | Standard Deviation 2.7328 |
| GSK2831781 0.15 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 2.193 Picogram per milliliter (pg/mL) | Standard Deviation 3.8186 |
| GSK2831781 0.15 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:6hours(n=14, 1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| GSK2831781 0.15 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 15.155 Picogram per milliliter (pg/mL) | Standard Deviation 21.9139 |
| GSK2831781 0.15 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 5.372 Picogram per milliliter (pg/mL) | Standard Deviation 4.201 |
| GSK2831781 0.15 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 12.302 Picogram per milliliter (pg/mL) | Standard Deviation 10.2985 |
| GSK2831781 0.15 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:12hours(n=13,1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| GSK2831781 0.15 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 1.825 Picogram per milliliter (pg/mL) | Standard Deviation 1.5788 |
| GSK2831781 0.15 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 6.768 Picogram per milliliter (pg/mL) | Standard Deviation 5.9501 |
| GSK2831781 0.15 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:24hours(n=14,1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| GSK2831781 0.15 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 39.248 Picogram per milliliter (pg/mL) | Standard Deviation 50.1491 |
| GSK2831781 0.15 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 16.748 Picogram per milliliter (pg/mL) | Standard Deviation 28.433 |
| GSK2831781 0.15 mg/kg (ADA-ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:48hours(n=12,1,1,6,6,6,5,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| GSK2831781 0.15 mg/kg (ADA+ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 2.272 Picogram per milliliter (pg/mL) | Standard Deviation 1.5898 |
| GSK2831781 0.15 mg/kg (ADA+ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 1.710 Picogram per milliliter (pg/mL) | Standard Deviation 1.9256 |
| GSK2831781 0.15 mg/kg (ADA+ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha:6hours (n=14,1,1,6,6,6,6,9,6,6,6) | 1.512 Picogram per milliliter (pg/mL) | Standard Deviation 1.3042 |
| GSK2831781 0.15 mg/kg (ADA+ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:48hours(n=12,1,1,6,6,6,5,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| GSK2831781 0.15 mg/kg (ADA+ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 2.710 Picogram per milliliter (pg/mL) | Standard Deviation 5.1169 |
| GSK2831781 0.15 mg/kg (ADA+ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 8.110 Picogram per milliliter (pg/mL) | Standard Deviation 10.8187 |
| GSK2831781 0.15 mg/kg (ADA+ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 6 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 1.847 Picogram per milliliter (pg/mL) | Standard Deviation 2.1026 |
| GSK2831781 0.15 mg/kg (ADA+ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 0.883 Picogram per milliliter (pg/mL) | Standard Deviation 2.1105 |
| GSK2831781 0.15 mg/kg (ADA+ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 6 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 1.142 Picogram per milliliter (pg/mL) | Standard Deviation 1.9865 |
| GSK2831781 0.15 mg/kg (ADA+ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | -0.657 Picogram per milliliter (pg/mL) | Standard Deviation 1.1306 |
| GSK2831781 0.15 mg/kg (ADA+ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:24hours(n=14,1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| GSK2831781 0.15 mg/kg (ADA+ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 34.603 Picogram per milliliter (pg/mL) | Standard Deviation 42.6294 |
| GSK2831781 0.15 mg/kg (ADA+ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 0.382 Picogram per milliliter (pg/mL) | Standard Deviation 1.0779 |
| GSK2831781 0.15 mg/kg (ADA+ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | -0.007 Picogram per milliliter (pg/mL) | Standard Deviation 1.7897 |
| GSK2831781 0.15 mg/kg (ADA+ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:6hours(n=14, 1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| GSK2831781 0.15 mg/kg (ADA+ve) | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:12hours(n=13,1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| Placebo for Psoriasis | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:6hours(n=14, 1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| Placebo for Psoriasis | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:48hours(n=12,1,1,6,6,6,5,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| Placebo for Psoriasis | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | -1.091 Picogram per milliliter (pg/mL) | Standard Deviation 1.6867 |
| Placebo for Psoriasis | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 21.447 Picogram per milliliter (pg/mL) | Standard Deviation 26.331 |
| Placebo for Psoriasis | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 21.774 Picogram per milliliter (pg/mL) | Standard Deviation 55.5319 |
| Placebo for Psoriasis | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | -0.029 Picogram per milliliter (pg/mL) | Standard Deviation 1.0534 |
| Placebo for Psoriasis | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:12hours(n=13,1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| Placebo for Psoriasis | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 4.284 Picogram per milliliter (pg/mL) | Standard Deviation 9.7552 |
| Placebo for Psoriasis | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha:6hours (n=14,1,1,6,6,6,6,9,6,6,6) | -0.402 Picogram per milliliter (pg/mL) | Standard Deviation 1.4406 |
| Placebo for Psoriasis | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | -0.301 Picogram per milliliter (pg/mL) | Standard Deviation 0.5766 |
| Placebo for Psoriasis | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 0.286 Picogram per milliliter (pg/mL) | Standard Deviation 1.1455 |
| Placebo for Psoriasis | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | -1.901 Picogram per milliliter (pg/mL) | Standard Deviation 1.8197 |
| Placebo for Psoriasis | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 6 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 1.518 Picogram per milliliter (pg/mL) | Standard Deviation 3.596 |
| Placebo for Psoriasis | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 6 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 15.003 Picogram per milliliter (pg/mL) | Standard Deviation 29.0749 |
| Placebo for Psoriasis | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:24hours(n=14,1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| Placebo for Psoriasis | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 3.321 Picogram per milliliter (pg/mL) | Standard Deviation 8.3425 |
| GSK2831781 0.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 7.425 Picogram per milliliter (pg/mL) | Standard Deviation 13.5089 |
| GSK2831781 0.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 5.993 Picogram per milliliter (pg/mL) | Standard Deviation 14.0442 |
| GSK2831781 0.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | -0.460 Picogram per milliliter (pg/mL) | Standard Deviation 1.8092 |
| GSK2831781 0.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | -1.140 Picogram per milliliter (pg/mL) | Standard Deviation 2.4624 |
| GSK2831781 0.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:6hours(n=14, 1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| GSK2831781 0.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 6 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 1.445 Picogram per milliliter (pg/mL) | Standard Deviation 1.9297 |
| GSK2831781 0.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:12hours(n=13,1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| GSK2831781 0.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:24hours(n=14,1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| GSK2831781 0.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 5.825 Picogram per milliliter (pg/mL) | Standard Deviation 9.9881 |
| GSK2831781 0.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:48hours(n=12,1,1,6,6,6,5,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| GSK2831781 0.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha:6hours (n=14,1,1,6,6,6,6,9,6,6,6) | 2.658 Picogram per milliliter (pg/mL) | Standard Deviation 1.7619 |
| GSK2831781 0.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 0.752 Picogram per milliliter (pg/mL) | Standard Deviation 0.9434 |
| GSK2831781 0.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 2.100 Picogram per milliliter (pg/mL) | Standard Deviation 1.9397 |
| GSK2831781 0.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 2.775 Picogram per milliliter (pg/mL) | Standard Deviation 1.2677 |
| GSK2831781 0.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 18.943 Picogram per milliliter (pg/mL) | Standard Deviation 26.2127 |
| GSK2831781 0.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 6 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 1.522 Picogram per milliliter (pg/mL) | Standard Deviation 2.6497 |
| GSK2831781 1.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 18.330 Picogram per milliliter (pg/mL) | Standard Deviation 22.5892 |
| GSK2831781 1.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 2.737 Picogram per milliliter (pg/mL) | Standard Deviation 1.8897 |
| GSK2831781 1.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:24hours(n=14,1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| GSK2831781 1.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 6 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 2.062 Picogram per milliliter (pg/mL) | Standard Deviation 1.5145 |
| GSK2831781 1.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 2.942 Picogram per milliliter (pg/mL) | Standard Deviation 2.4473 |
| GSK2831781 1.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 4.265 Picogram per milliliter (pg/mL) | Standard Deviation 2.6663 |
| GSK2831781 1.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 1.712 Picogram per milliliter (pg/mL) | Standard Deviation 1.1398 |
| GSK2831781 1.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:12hours(n=13,1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| GSK2831781 1.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:6hours(n=14, 1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| GSK2831781 1.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 3.150 Picogram per milliliter (pg/mL) | Standard Deviation 2.0492 |
| GSK2831781 1.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 10.667 Picogram per milliliter (pg/mL) | Standard Deviation 6.9406 |
| GSK2831781 1.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 6 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 3.157 Picogram per milliliter (pg/mL) | Standard Deviation 3.7276 |
| GSK2831781 1.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 1.047 Picogram per milliliter (pg/mL) | Standard Deviation 2.7193 |
| GSK2831781 1.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 0.163 Picogram per milliliter (pg/mL) | Standard Deviation 0.6664 |
| GSK2831781 1.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:48hours(n=12,1,1,6,6,6,5,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| GSK2831781 1.5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha:6hours (n=14,1,1,6,6,6,6,9,6,6,6) | 2.678 Picogram per milliliter (pg/mL) | Standard Deviation 1.6019 |
| GSK2831781 5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 9.208 Picogram per milliliter (pg/mL) | Standard Deviation 13.2078 |
| GSK2831781 5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 6 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 3.837 Picogram per milliliter (pg/mL) | Standard Deviation 6.7895 |
| GSK2831781 5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:24hours(n=14,1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| GSK2831781 5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 11.120 Picogram per milliliter (pg/mL) | Standard Deviation 6.7124 |
| GSK2831781 5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 0.300 Picogram per milliliter (pg/mL) | Standard Deviation 3.0864 |
| GSK2831781 5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 1.987 Picogram per milliliter (pg/mL) | Standard Deviation 5.9878 |
| GSK2831781 5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:48hours(n=12,1,1,6,6,6,5,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| GSK2831781 5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | -1.145 Picogram per milliliter (pg/mL) | Standard Deviation 2.8564 |
| GSK2831781 5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha:6hours (n=14,1,1,6,6,6,6,9,6,6,6) | 3.455 Picogram per milliliter (pg/mL) | Standard Deviation 1.7634 |
| GSK2831781 5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 2.753 Picogram per milliliter (pg/mL) | Standard Deviation 1.1083 |
| GSK2831781 5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-8: 6 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 4.063 Picogram per milliliter (pg/mL) | Standard Deviation 3.7411 |
| GSK2831781 5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 2.502 Picogram per milliliter (pg/mL) | Standard Deviation 1.7958 |
| GSK2831781 5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | IL-6: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 11.893 Picogram per milliliter (pg/mL) | Standard Deviation 16.0968 |
| GSK2831781 5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:12hours(n=13,1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
| GSK2831781 5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | TNF alpha: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6) | 1.083 Picogram per milliliter (pg/mL) | Standard Deviation 0.8472 |
| GSK2831781 5 mg/kg | Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha | Interferon-gamma:6hours(n=14, 1,1,6,6,6,6,9,6,6,6) | 0.00 Picogram per milliliter (pg/mL) | Standard Deviation 0 |
Primary
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) of PCI
Triplicate ECG was measured in a semi-supine position after 5 minutes rest. A single 12-lead ECG was obtained by using an ECG machine that automatically calculates heart rate and measured PR, QRS, QT, and Fridericia's formula (QTcF) intervals. The PCI ranges for QTc Interval (high: \>450 millisecond \[msec\]), PR Interval (low: \<110 msec and high: \>220 msec) and QRS Interval (low: \<75 msec and high: \>110 msec). Number of participants with ECG values of PCI are presented.
Time frame: Up to 307 days
Population: Safety population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) of PCI | 2 Participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) of PCI | 0 Participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) of PCI | 0 Participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) of PCI | 0 Participants |
| GSK2831781 0.04 mg/kg (ADA-ve) | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) of PCI | 0 Participants |
| GSK2831781 0.15 mg/kg (ADA-ve) | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) of PCI | 1 Participants |
| GSK2831781 0.15 mg/kg (ADA+ve) | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) of PCI | 2 Participants |
| Placebo for Psoriasis | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) of PCI | 2 Participants |
| GSK2831781 0.5 mg/kg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) of PCI | 0 Participants |
| GSK2831781 1.5 mg/kg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) of PCI | 3 Participants |
| GSK2831781 5 mg/kg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) of PCI | 1 Participants |
Primary
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.
Time frame: 6, 12, 72, 168 hours, Day 15 and 29
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Occult blood: 6 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Occult blood: 6 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Occult blood: 6 hours, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Occult blood: 6 hours, 7 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Occult blood: 12 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Occult blood: 12 hours, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Occult blood: 12 hours, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Occult blood: 72 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Occult blood: 72 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Occult blood: 72 hours, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Occult blood: 72 hours, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Occult blood: 168 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Occult blood: 168 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Occult blood: 168 hours, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Occult blood: 168 hours, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Occult blood: Day 15, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Occult blood: Day 29, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Occult blood: Day 29, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Occult blood: Day 29, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Glucose: 6 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Glucose: 6 hours, 17 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Glucose: 6 hours, 7 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Glucose: 12 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Glucose: 72 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Glucose: 72 hours, 3 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Glucose: 168 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Glucose: Day 15, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Glucose: Day 29, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Ketones: 6 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Ketones: 6 hours, 7 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Ketones: 12 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Ketones: 12 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Ketones: 72 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Ketones: 72 hours, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Ketones: 168 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Ketones: 168 hours, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Ketones: 168 hours, 4+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Ketones: Day 15, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Ketones: Day 15, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Ketones: Day 29, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Ketones: Day 29, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Ketones: Day 29, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Nitrite: Day 15, positive | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Protein: 6 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Protein: 6 hours, 7 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Protein: 12 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Protein: 12 hours, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Protein: 72 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Protein: 72 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Protein: 168 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Protein: 168 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Protein: 168 hours, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Protein: 168 hours, 3+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Protein: Day 15, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Protein: Day 15, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Protein: Day 29, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve) | Protein: Day 29, 1+ | 0 Participants |
Primary
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.
Time frame: 6, 12, 72, 168 hours, Days 15, 29 and 43
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Occult blood: 6 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Occult blood: 6 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Occult blood: 6 hours, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Occult blood: 6 hours, 7 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Occult blood: 12 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Occult blood: 12 hours, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Occult blood: 12 hours, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Occult blood: 72 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Occult blood: 72 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Occult blood: 72 hours, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Occult blood: 72 hours, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Occult blood: 168 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Occult blood: 168 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Occult blood: 168 hours, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Occult blood: 168 hours, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Occult blood: Day 15, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Occult blood: Day 29, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Occult blood: Day 29, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Occult blood: Day 29, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Occult blood: Day 29, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Occult blood: Day 43, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Occult blood: Day 43, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Occult blood: Day 43, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Glucose: 6 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Glucose: 6 hours, 17 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Glucose: 6 hours, 7 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Glucose: 12 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Glucose: 72 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Glucose: 72 hours, 3 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Glucose: 168 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Glucose: Day 15, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Glucose: Day 29, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Glucose: Day 43, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Ketones: 6 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Ketones: 6 hours, 7 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Ketones: 12 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Ketones: 12 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Ketones: 72 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Ketones: 72 hours, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Ketones: 168 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Ketones: 168 hours, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Ketones: 168 hours, 4+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Ketones: Day 15, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Ketones: Day 15, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Ketones: Day 29, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Ketones: Day 29, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Ketones: Day 43, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Ketones: Day 43, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Ketones: Day 43, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Nitrite: Day 15, positive | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Protein: 6 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Protein: 6 hours, 7 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Protein: 12 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Protein: 12 hours, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Protein: 72 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Protein: 72 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Protein: 168 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Protein: 168 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Protein: 168 hours, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Protein: 168 hours, 3+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Protein: Day 15, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Protein: Day 15, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Protein: Day 29, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Protein: Day 29, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Protein: Day 43, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve) | Protein: Day 43, 1+ | 0 Participants |
Primary
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.
Time frame: 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57 and 85
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: 6 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: 6 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: 6 hours, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: 6 hours, 7 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: 12 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: 12 hours, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: 12 hours, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: 72 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: 72 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: 72 hours, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: 72 hours, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: 168 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: 168 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: 168 hours, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: 168 hours, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: Day 15, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: Day 22, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: Day 22, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: Day 22, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: Day 29, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: Day 29, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: Day 29, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: Day 29, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: Day 29, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: Day 43, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: Day 43, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: Day 43, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: Day 43, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: Day 57, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: Day 57, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: Day 57, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: Day 85, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: Day 85, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Occult blood: Day 85, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Glucose: 6 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Glucose: 6 hours, 17 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Glucose: 6 hours, 7 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Glucose: 12 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Glucose: 72 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Glucose: 72 hours, 3 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Glucose: 168 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Glucose: Day 15, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Glucose: Day 22, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Glucose: Day 29, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Glucose: Day 43, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Glucose: Day 57, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Glucose: Day 85, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Ketones: 6 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Ketones: 6 hours, 7 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Ketones: 12 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Ketones: 12 hours, 1+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Ketones: 72 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Ketones: 72 hours, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Ketones: 168 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Ketones: 168 hours, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Ketones: 168 hours, 4+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Ketones: Day 15, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Ketones: Day 15, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Ketones: Day 22, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Ketones: Day 22, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Ketones: Day 29, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Ketones: Day 29, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Ketones: Day 43, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Ketones: Day 43, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Ketones: Day 43, 1.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Ketones: Day 57, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Ketones: Day 85, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Ketones: Day 85, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Ketones: Day 85, 1+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Nitrite: Day 15, positive | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Protein: 6 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Protein: 6 hours, 7 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Protein: 12 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Protein: 12 hours, 2+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Protein: 72 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Protein: 72 hours, 1+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Protein: 168 hours, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Protein: 168 hours, 1+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Protein: 168 hours, 2+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Protein: 168 hours, 3+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Protein: Day 15, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Protein: Day 15, 1+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Protein: Day 22, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Protein: Day 22, 1+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Protein: Day 29, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Protein: Day 29, 1+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Protein: Day 43, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Protein: Day 43, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Protein: Day 57, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Protein: Day 57, 1+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Protein: Day 85, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve) | Protein: Day 85, 1+ | 0 Participants |
Primary
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.
Time frame: 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 147
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: 6 hours, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: 6 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: 6 hours, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: 6 hours, 7 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: 12 hours, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: 12 hours, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: 12 hours, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: 72 hours, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: 72 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: 72 hours, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: 72 hours, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: 168 hours, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: 168 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: 168 hours, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: 168 hours, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: Day 15, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: Day 22, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: Day 22, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: Day 22, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: Day 29, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: Day 29, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: Day 29, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: Day 29, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: Day 29, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: Day 43, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: Day 43, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: Day 43, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: Day 43, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: Day 57, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: Day 57, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: Day 57, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: Day 85, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: Day 85, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: Day 121, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: Day 121, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: Day 121, 10 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: Day 147, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: Day 147, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Occult blood: Day 147, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Glucose: 6 hours, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Glucose: 6 hours, 17 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Glucose: 6 hours, 7 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Glucose: 12 hours, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Glucose: 72 hours, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Glucose: 72 hours, 3 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Glucose: 168 hours, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Glucose: Day 15, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Glucose: Day 22, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Glucose: Day 29, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Glucose: Day 43, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Glucose: Day 57, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Glucose: Day 85, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Glucose: Day 121, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Glucose: Day 147, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Ketones: 6 hours, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Ketones: 6 hours, 7 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Ketones: 12 hours, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Ketones: 12 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Ketones: 72 hours, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Ketones: 72 hours, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Ketones: 168 hours, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Ketones: 168 hours, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Ketones: 168 hours, 4+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Ketones: Day 15, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Ketones: Day 15, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Ketones: Day 22, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Ketones: Day 22, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Ketones: Day 29, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Ketones: Day 29, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Ketones: Day 43, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Ketones: Day 43, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Ketones: Day 43, 1.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Ketones: Day 57, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Ketones: Day 85, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Ketones: Day 85, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Ketones: Day 121, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Ketones: Day 121, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Ketones: Day 121, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Ketones: Day 147, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Ketones: Day 147, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Ketones: Day 147, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Nitrite: Day 15, positive | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Nitrite: Day 85, positive | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Nitrite: Day 121, positive | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Protein: 6 hours, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Protein: 6 hours, 7 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Protein: 12 hours, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Protein: 12 hours, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Protein: 72 hours, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Protein: 72 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Protein: 168 hours, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Protein: 168 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Protein: 168 hours, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Protein: 168 hours, 3+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Protein: Day 15, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Protein: Day 15, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Protein: Day 22, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Protein: Day 22, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Protein: Day 29, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Protein: Day 29, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Protein: Day 43, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Protein: Day 43, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Protein: Day 57, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Protein: Day 57, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Protein: Day 85, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Protein: Day 85, 1+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Protein: Day 121, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Protein: Day 147, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve) | Protein: Day 147, 1+ | 0 Participants |
Primary
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.
Time frame: 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 219
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: 6 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: 6 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: 6 hours, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: 6 hours, 7 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: 12 hours, 0 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: 12 hours, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: 12 hours, 25 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: 72 hours, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: 72 hours, 1+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: 72 hours, 10 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: 72 hours, 50 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: 168 hours, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: 168 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: 168 hours, 10 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: 168 hours, 25 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: Day 15, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: Day 22, 0 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: Day 22, 10 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: Day 22, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: Day 29, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: Day 29, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: Day 29, 10 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: Day 29, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: Day 29, 25 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: Day 43, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: Day 43, 1+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: Day 43, 10 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: Day 43, 25 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: Day 57, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: Day 57, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Glucose: 6 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Glucose: 6 hours, 17 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Glucose: 6 hours, 7 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Glucose: 12 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Glucose: 72 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Glucose: 72 hours, 3 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Glucose: 168 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Glucose: Day 15, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Glucose: Day 22, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Glucose: Day 29, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Glucose: Day 43, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Glucose: Day 57, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Glucose: Day 85, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Glucose: Day 121, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Glucose: Day 219, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Ketones: 6 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Ketones: 6 hours, 7 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Ketones: 12 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Ketones: 12 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Ketones: 72 hours, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Ketones: 72 hours, 0.5 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Ketones: 168 hours, 0 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Ketones: 168 hours, 0.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Ketones: 168 hours, 4+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Ketones: Day 15, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Ketones: Day 15, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Ketones: Day 22, 0 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Ketones: Day 22, 0.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Ketones: Day 29, 0 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Ketones: Day 29, 0.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Ketones: Day 43, 0 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Ketones: Day 43, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Ketones: Day 43, 1.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Ketones: Day 57, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Ketones: Day 85, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Ketones: Day 85, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Ketones: Day 121, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Ketones: Day 121, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Ketones: Day 121, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Ketones: Day 219, 0 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Ketones: Day 219, 0.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Ketones: Day 219, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Nitrite: Day 15, positive | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: Day 57, 10 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: Day 85, 0 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: Day 85, 10 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: Day 121, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: Day 121, 1+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: Day 121, 10 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: Day 219, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: Day 219, 10 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Occult blood: Day 219, 25 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Nitrite: Day 85, positive | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Nitrite: Day 121, positive | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Protein: 6 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Protein: 6 hours, 7 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Protein: 12 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Protein: 12 hours, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Protein: 72 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Protein: 72 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Protein: 168 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Protein: 168 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Protein: 168 hours, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Protein: 168 hours, 3+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Protein: Day 15, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Protein: Day 15, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Protein: Day 22, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Protein: Day 22, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Protein: Day 29, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Protein: Day 29, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Protein: Day 43, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Protein: Day 43, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Protein: Day 57, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Protein: Day 57, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Protein: Day 85, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Protein: Day 85, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Protein: Day 121, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Protein: Day 219, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve) | Protein: Day 219, 1+ | 0 Participants |
Primary
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.
Time frame: 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 191
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Ketones: 72 hours, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Protein: Day 85, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Protein: Day 85, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Glucose: Day 57, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Glucose: Day 85, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Glucose: Day 121, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Glucose: Day 191, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Ketones: 6 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Ketones: 6 hours, 7 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Ketones: 12 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Ketones: 12 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Ketones: 72 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Ketones: 168 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Ketones: 168 hours, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Ketones: 168 hours, 4+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Ketones: Day 15, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Ketones: Day 15, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Ketones: Day 22, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Ketones: Day 22, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Ketones: Day 29, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Ketones: Day 29, 0.5 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Ketones: Day 43, 0 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Ketones: Day 43, 0.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Ketones: Day 43, 1.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Ketones: Day 57, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Ketones: Day 85, 0 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Ketones: Day 85, 0.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Ketones: Day 121, 0 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Ketones: Day 121, 0.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Ketones: Day 121, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Ketones: Day 191, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Ketones: Day 191, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Ketones: Day 191, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Nitrite: Day 15, positive | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Nitrite: Day 85, positive | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Nitrite: Day 121, positive | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Protein: 6 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Protein: 6 hours, 7 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Protein: 12 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Protein: 12 hours, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Protein: 72 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Protein: 72 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Protein: 168 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Protein: 168 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Protein: 168 hours, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Protein: 168 hours, 3+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Protein: Day 15, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Protein: Day 15, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Protein: Day 22, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Protein: Day 22, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Protein: Day 29, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Protein: Day 29, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Protein: Day 43, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Protein: Day 43, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Protein: Day 57, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Protein: Day 57, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Protein: Day 121, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Protein: Day 191, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Protein: Day 191, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: 72 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: 72 hours, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: 168 hours, 0 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: 168 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: 168 hours, 10 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: 168 hours, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: Day 15, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: Day 22, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: Day 22, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: Day 22, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: Day 29, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: Day 29, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: Day 29, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: Day 29, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: Day 29, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: Day 43, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: Day 43, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: Day 43, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: Day 43, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: Day 57, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: Day 57, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: 6 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: 6 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: 6 hours, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: 6 hours, 7 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: 12 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: 12 hours, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: 12 hours, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: 72 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Glucose: 12 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Glucose: 72 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Glucose: 72 hours, 3 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Glucose: 168 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Glucose: Day 15, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Glucose: Day 22, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Glucose: Day 29, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Glucose: Day 43, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: Day 57, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: Day 85, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: Day 85, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: 72 hours, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: Day 121, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: Day 121, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: Day 121, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: Day 191, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: Day 191, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Occult blood: Day 191, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Glucose: 6 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Glucose: 6 hours, 17 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve) | Glucose: 6 hours, 7 | 0 Participants |
Primary
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.
Time frame: 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 237
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: 6 hours, + | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: 6 hours, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: 6 hours, 1+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: 6 hours, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: 6 hours, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: 12 hours, + | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: 12 hours, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: 12 hours, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: 12 hours, 150 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: 12 hours, 2+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: 12 hours, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: 12 hours, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: 72 hours, + | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: 72 hours, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: 72 hours, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: 72 hours, 150 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: 72 hours, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: 168 hours, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: 168 hours, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: 168 hours, 150 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: 168 hours, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: 168 hours, 250 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 15, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 15, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 15, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 15, 250 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 15, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 22, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 22, 1+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 22, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 22, 150 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 22, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 22, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 29, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 29, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 29, 150 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 29, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 43, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 43, 10 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 43, 150 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 43, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 43, 3+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 43, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 57, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 57, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 57, 150 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 57, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 57, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 85, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 85, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 85, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 85, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 121, + | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 121, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 121, 1+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 121, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 121, 150 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 121, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 237, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 237, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 237, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Occult blood: Day 237, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Glucose: 6 hours, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Glucose: 12 hours, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Glucose: 12 hours, 9 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Glucose: 72 hours, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Glucose: 168 hours, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Glucose: Day 15, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Glucose: Day 22, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Glucose: Day 22, 5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Glucose: Day 29, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Glucose: Day 43, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Glucose: Day 57, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Glucose: Day 85, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Glucose: Day 121, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Glucose: Day 237, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Ketones: 6 hours, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Ketones: 12 hours, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Ketones: 12 hours, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Ketones: 72 hours, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Ketones: 72 hours, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Ketones: 168 hours, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Ketones: 168 hours, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Ketones: Day 15, 0 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Ketones: Day 15, 0.5 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Ketones: Day 22, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Ketones: Day 22, 0.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Ketones: Day 29, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Ketones: Day 29, 0.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Ketones: Day 43, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Ketones: Day 43, 0.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Ketones: Day 43, 1.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Ketones: Day 57, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Ketones: Day 57, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Ketones: Day 85, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Ketones: Day 85, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Ketones: Day 121, 0 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Ketones: Day 121, 0.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Ketones: Day 237, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Ketones: Day 237, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Nitrite: Day 15, positive | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Protein: 6 hours, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Protein: 12 hours, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Protein: 72 hours, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Protein: 168 hours, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Protein: 168 hours, 0.25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Protein: 168 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Protein: Day 15, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Protein: Day 15, 0.25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Protein: Day 22, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Protein: Day 22, 0.25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Protein: Day 29, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Protein: Day 29, 0.25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Protein: Day 29, 1+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Protein: Day 43, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Protein: Day 43, 0.25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Protein: Day 57, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Protein: Day 85, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Protein: Day 85, 0.25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Protein: Day 85, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Protein: Day 121, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Protein: Day 237, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg | Protein: Day 237, 0.25 | 0 Participants |
Primary
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.
Time frame: 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 277
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Ketones: Day 43, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Protein: 72 hours, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Protein: Day 85, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: 6 hours, + | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: 6 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: 6 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: 6 hours, 10 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: 6 hours, 50 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: 12 hours, + | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: 12 hours, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: 12 hours, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: 12 hours, 150 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: 12 hours, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: 12 hours, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: 12 hours, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: 72 hours, + | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: 72 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: 72 hours, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: 72 hours, 150 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: 72 hours, 25 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: 168 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: 168 hours, 10 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: 168 hours, 150 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: 168 hours, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: 168 hours, 250 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 15, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 15, 10 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 15, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 15, 250 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 15, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 22, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 22, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 22, 10 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 22, 150 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 22, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 22, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 29, 0 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 29, 10 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 29, 150 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 29, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 43, 0 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 43, 10 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 43, 150 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 43, 25 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 43, 3+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 43, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 57, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 57, 10 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 57, 150 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 57, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 57, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 85, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 85, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 85, 25 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 85, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 121, + | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 121, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 121, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 121, 10 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 121, 150 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 121, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 277, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 277, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 277, 25 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Occult blood: Day 277, 50 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Glucose: 6 hours, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Glucose: 12 hours, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Glucose: 12 hours, 9 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Glucose: 72 hours, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Glucose: 168 hours, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Glucose: Day 15, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Glucose: Day 22, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Glucose: Day 22, 5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Glucose: Day 29, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Glucose: Day 43, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Glucose: Day 57, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Glucose: Day 85, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Glucose: Day 121, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Glucose: Day 277, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Ketones: 6 hours, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Ketones: 12 hours, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Ketones: 12 hours, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Ketones: 72 hours, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Ketones: 72 hours, 0.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Ketones: 168 hours, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Ketones: 168 hours, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Ketones: Day 15, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Ketones: Day 15, 0.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Ketones: Day 22, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Ketones: Day 22, 0.5 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Ketones: Day 29, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Ketones: Day 29, 0.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Ketones: Day 43, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Ketones: Day 43, 1.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Ketones: Day 57, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Ketones: Day 57, 0.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Ketones: Day 85, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Ketones: Day 85, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Ketones: Day 121, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Ketones: Day 121, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Ketones: Day 277, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Ketones: Day 277, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Nitrite: Day 15, positive | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Protein: 6 hours, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Protein: 12 hours, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Protein: 168 hours, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Protein: 168 hours, 0.25 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Protein: 168 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Protein: Day 15, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Protein: Day 15, 0.25 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Protein: Day 22, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Protein: Day 22, 0.25 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Protein: Day 29, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Protein: Day 29, 0.25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Protein: Day 29, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Protein: Day 43, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Protein: Day 43, 0.25 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Protein: Day 57, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Protein: Day 85, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Protein: Day 85, 0.25 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Protein: Day 121, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Protein: Day 277, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg | Protein: Day 277, 0.25 | 1 Participants |
Primary
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.
Time frame: 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 307
Population: Safety population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 15, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 15, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 57, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 121, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 121, 10 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Ketones: Day 22, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Ketones: Day 57, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Ketones: Day 57, 0.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Ketones: Day 85, 0 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Ketones: Day 85, 0.5 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Nitrite: Day 15, positive | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Protein: 6 hours, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Protein: Day 15, 0.25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Protein: Day 22, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Protein: Day 29, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Protein: Day 29, 0.25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Protein: Day 29, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Protein: Day 43, 0.25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Protein: Day 307, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: 6 hours, + | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: 6 hours, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: 6 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: 6 hours, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: 6 hours, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: 12 hours, + | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: 12 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: 12 hours, 10 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: 12 hours, 150 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: 12 hours, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: 12 hours, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: 12 hours, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: 72 hours, + | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: 72 hours, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: 72 hours, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: 72 hours, 150 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: 72 hours, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: 168 hours, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: 168 hours, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: 168 hours, 150 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: 168 hours, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: 168 hours, 250 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 15, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 15, 250 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 15, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 22, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 22, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 22, 10 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 22, 150 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 22, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 22, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 29, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 29, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 29, 150 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 29, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 43, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 43, 10 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 43, 150 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 43, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 43, 3+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 43, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 57, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 57, 150 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 57, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 57, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 85, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 85, 10 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 85, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 85, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 121, + | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 121, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 121, 150 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 121, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 307, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 307, 10 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 307, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Occult blood: Day 307, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Glucose: 6 hours, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Glucose: 12 hours, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Glucose: 12 hours, 9 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Glucose: 72 hours, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Glucose: 168 hours, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Glucose: Day 15, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Glucose: Day 22, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Glucose: Day 22, 5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Glucose: Day 29, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Glucose: Day 43, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Glucose: Day 57, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Glucose: Day 85, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Glucose: Day 121, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Glucose: Day 307, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Ketones: 6 hours, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Ketones: 12 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Ketones: 12 hours, 0.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Ketones: 72 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Ketones: 72 hours, 0.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Ketones: 168 hours, 0 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Ketones: 168 hours, 0.5 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Ketones: Day 15, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Ketones: Day 15, 0.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Ketones: Day 22, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Ketones: Day 29, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Ketones: Day 29, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Ketones: Day 43, 0 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Ketones: Day 43, 0.5 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Ketones: Day 43, 1.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Ketones: Day 121, 0 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Ketones: Day 121, 0.5 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Ketones: Day 307, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Ketones: Day 307, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Protein: 12 hours, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Protein: 72 hours, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Protein: 168 hours, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Protein: 168 hours, 0.25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Protein: 168 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Protein: Day 15, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Protein: Day 22, 0.25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Protein: Day 43, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Protein: Day 57, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Protein: Day 85, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Protein: Day 85, 0.25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Protein: Day 85, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Protein: Day 121, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg | Protein: Day 307, 0.25 | 0 Participants |
Primary
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.
Time frame: 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 307
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: 6 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: 6 hours, 10 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: 6 hours, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 121, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 121, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Ketones: Day 29, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Ketones: Day 29, 0.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Ketones: Day 43, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Ketones: Day 43, 0.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Ketones: Day 43, 1.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Ketones: Day 57, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Ketones: Day 57, 0.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Ketones: Day 85, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Ketones: Day 85, 0.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Ketones: Day 121, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Ketones: Day 121, 0.5 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Ketones: Day 307, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Ketones: Day 307, 0.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Nitrite: Day 15, positive | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Protein: 6 hours, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Protein: 12 hours, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Protein: 72 hours, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Protein: 168 hours, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Protein: 168 hours, 0.25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Protein: 168 hours, 1+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Protein: Day 15, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Protein: Day 15, 0.25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Protein: Day 22, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Protein: Day 22, 0.25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Protein: Day 29, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Protein: Day 29, 0.25 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Protein: Day 29, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Protein: Day 43, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Protein: Day 43, 0.25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Protein: Day 57, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Protein: Day 85, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Protein: Day 85, 0.25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Protein: Day 85, 1+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Protein: Day 121, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Protein: Day 307, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Protein: Day 307, 0.25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: 6 hours, + | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: 6 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: 12 hours, + | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: 12 hours, 0 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: 12 hours, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: 12 hours, 150 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: 12 hours, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: 12 hours, 25 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: 12 hours, 50 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: 72 hours, + | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: 72 hours, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: 72 hours, 10 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: 72 hours, 150 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: 72 hours, 25 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: 168 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: 168 hours, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: 168 hours, 150 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: 168 hours, 25 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: 168 hours, 250 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 15, 0 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 15, 10 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 15, 25 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 15, 250 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 15, 50 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 22, 0 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 22, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 22, 10 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 22, 150 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 22, 25 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 22, 50 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 29, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 29, 10 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 29, 150 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 29, 50 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 43, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 43, 10 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 43, 150 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 43, 25 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 43, 3+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 43, 50 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 57, 0 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 57, 10 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 57, 150 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 57, 25 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 57, 50 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 85, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 85, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 85, 25 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 85, 50 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 121, + | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 121, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 121, 150 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 121, 25 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 307, 0 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 307, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 307, 25 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Occult blood: Day 307, 50 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Glucose: 6 hours, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Glucose: 12 hours, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Glucose: 12 hours, 9 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Glucose: 72 hours, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Glucose: 168 hours, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Glucose: Day 15, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Glucose: Day 22, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Glucose: Day 22, 5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Glucose: Day 29, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Glucose: Day 43, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Glucose: Day 57, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Glucose: Day 85, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Glucose: Day 121, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Glucose: Day 307, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Ketones: 6 hours, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Ketones: 12 hours, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Ketones: 12 hours, 0.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Ketones: 72 hours, 0 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Ketones: 72 hours, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Ketones: 168 hours, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Ketones: 168 hours, 0.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Ketones: Day 15, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Ketones: Day 15, 0.5 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Ketones: Day 22, 0 | 5 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo | Ketones: Day 22, 0.5 | 1 Participants |
Primary
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.
Time frame: 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 191
Population: Safety population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: 6 hours, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: 6 hours, 1+ | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: 6 hours, 10 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: 6 hours, 7 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: 12 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: 12 hours, 2+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: 12 hours, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: 72 hours, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: 72 hours, 1+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: 72 hours, 10 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: 72 hours, 50 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: 168 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: 168 hours, 1+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: 168 hours, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: 168 hours, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: Day 15, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: Day 22, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: Day 22, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: Day 22, 2+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: Day 29, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: Day 29, 1+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: Day 29, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: Day 29, 2+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Glucose: 6 hours, 7 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: Day 29, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: Day 43, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: Day 43, 1+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: Day 43, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: Day 43, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: Day 57, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: Day 57, 1+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: Day 57, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: Day 85, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: Day 85, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: Day 121, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: Day 121, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: Day 121, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: Day 191, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: Day 191, 10 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Occult blood: Day 191, 25 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Glucose: 6 hours, 0 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Glucose: 6 hours, 17 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Glucose: 12 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Glucose: 72 hours, 0 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Glucose: 72 hours, 3 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Glucose: 168 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Glucose: Day 15, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Glucose: Day 22, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Glucose: Day 29, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Protein: 168 hours, 3+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Glucose: Day 43, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Glucose: Day 57, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Protein: Day 15, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Glucose: Day 85, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Glucose: Day 121, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Glucose: Day 191, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Ketones: 6 hours, 0 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Ketones: 6 hours, 7 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Ketones: 12 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Ketones: 12 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Protein: Day 15, 1+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Ketones: 72 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Ketones: 72 hours, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Ketones: 168 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Ketones: 168 hours, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Ketones: 168 hours, 4+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Ketones: Day 15, 0 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Ketones: Day 15, 0.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Ketones: Day 22, 0 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Ketones: Day 22, 0.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Ketones: Day 29, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Ketones: Day 29, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Ketones: Day 43, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Ketones: Day 43, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Ketones: Day 43, 1.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Ketones: Day 57, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Ketones: Day 85, 0 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Protein: Day 22, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Ketones: Day 85, 0.5 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Ketones: Day 121, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Ketones: Day 121, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Ketones: Day 121, 2+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Ketones: Day 191, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Ketones: Day 191, 0.5 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Ketones: Day 191, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Nitrite: Day 15, positive | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Nitrite: Day 85, positive | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Nitrite: Day 121, positive | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Protein: 6 hours, 0 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Protein: 6 hours, 7 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Protein: 12 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Protein: 12 hours, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Protein: 72 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Protein: 72 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Protein: 168 hours, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Protein: 168 hours, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Protein: 168 hours, 2+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Protein: Day 22, 1+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Protein: Day 29, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Protein: Day 29, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Protein: Day 43, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Protein: Day 43, 1+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Protein: Day 57, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Protein: Day 57, 1+ | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Protein: Day 85, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Protein: Day 85, 1+ | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Protein: Day 121, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Protein: Day 191, 0 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers | Protein: Day 191, 1+ | 2 Participants |
Primary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect and other important medical events judged by the investigator that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.
Time frame: Up to 307 days
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 8 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 0 Participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 0 Participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 5 Participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| GSK2831781 0.04 mg/kg (ADA-ve) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 6 Participants |
| GSK2831781 0.04 mg/kg (ADA-ve) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| GSK2831781 0.15 mg/kg (ADA-ve) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| GSK2831781 0.15 mg/kg (ADA-ve) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 3 Participants |
| GSK2831781 0.15 mg/kg (ADA+ve) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| GSK2831781 0.15 mg/kg (ADA+ve) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 3 Participants |
| Placebo for Psoriasis | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 9 Participants |
| Placebo for Psoriasis | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| GSK2831781 0.5 mg/kg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 4 Participants |
| GSK2831781 0.5 mg/kg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| GSK2831781 1.5 mg/kg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 6 Participants |
| GSK2831781 1.5 mg/kg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| GSK2831781 5 mg/kg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 6 Participants |
| GSK2831781 5 mg/kg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 1 Participants |
Primary
Number of Participants With Clinical Chemistry Abnormalities of PCI
Clinical chemistry parameters and their potential clinical concern values: albumin (low: \<30 millimoles per liter \[mmol/L\]), calcium (low: \<2 mmol/L, high: \>2.75 mmol/L), creatinine (high: \>44.2 mmol/L), glucose (low: \<3 mmol/L, high: \>9 mmol/L), magnesium (low: \<0.5 mmol/L, high: \>1.23 mmol/L), phosphorus (low: \<0.8 mmol/L, high: \>1.6 mmol/L), potassium (low: \<3 mmol/L, high: \>5.5 mmol/L), sodium (low: \<130 mmol/L, high: \>150 mmol/L), and total carbon dioxide (CO2) (low: \<18 mmol/L, high: \>32 mmol/L). Number of participants with clinical chemistry of PCI are presented.
Time frame: Up to 307 days
Population: Safety population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | Number of Participants With Clinical Chemistry Abnormalities of PCI | 1 Participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Number of Participants With Clinical Chemistry Abnormalities of PCI | 0 Participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Number of Participants With Clinical Chemistry Abnormalities of PCI | 0 Participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Number of Participants With Clinical Chemistry Abnormalities of PCI | 1 Participants |
| GSK2831781 0.04 mg/kg (ADA-ve) | Number of Participants With Clinical Chemistry Abnormalities of PCI | 1 Participants |
| GSK2831781 0.15 mg/kg (ADA-ve) | Number of Participants With Clinical Chemistry Abnormalities of PCI | 1 Participants |
| GSK2831781 0.15 mg/kg (ADA+ve) | Number of Participants With Clinical Chemistry Abnormalities of PCI | 1 Participants |
| Placebo for Psoriasis | Number of Participants With Clinical Chemistry Abnormalities of PCI | 3 Participants |
| GSK2831781 0.5 mg/kg | Number of Participants With Clinical Chemistry Abnormalities of PCI | 1 Participants |
| GSK2831781 1.5 mg/kg | Number of Participants With Clinical Chemistry Abnormalities of PCI | 0 Participants |
| GSK2831781 5 mg/kg | Number of Participants With Clinical Chemistry Abnormalities of PCI | 3 Participants |
Primary
Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI)
Hematology parameters with PCI ranges: hematocrit (high: \>0.54 percentage of red blood cells), hemoglobin (high: \>180 grams per liter \[g/L\]), lymphocytes (low: \<0.8\*giga cells per liter \[10\^9/L\]), neutrophil count (low: \<1.5\*10\^9/L), platelet count (low: \<100\*10\^9/L and high: \>550\*10\^9/L), and while blood cell count (low: \<3\*10\^9/L and high: \>20\*10\^9/L) for healthy volunteers and psoriasis participants. Safety population consisted of all randomized participants who received at least one dose of study treatment. Only those participants for which at least one value of PCI was reported are summarized.
Time frame: Up to 307 days
Population: Safety population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | 3 Participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | 0 Participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | 0 Participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | 0 Participants |
| GSK2831781 0.04 mg/kg (ADA-ve) | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | 0 Participants |
| GSK2831781 0.15 mg/kg (ADA-ve) | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | 0 Participants |
| GSK2831781 0.15 mg/kg (ADA+ve) | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | 0 Participants |
| Placebo for Psoriasis | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | 0 Participants |
| GSK2831781 0.5 mg/kg | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | 0 Participants |
| GSK2831781 1.5 mg/kg | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | 0 Participants |
| GSK2831781 5 mg/kg | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | 1 Participants |
Primary
Number of Participants With Vital Signs of PCI
Vital signs included heart rate, systolic and diastolic blood pressure and body temperature were performed with the participant in a semi-supine position after the participant had rested for at least 5 minutes. The PCI range for heart rate (low: \<40 beats per minute \[BPM\] and high: \>110 BPM), systolic blood pressure (low: \<85 and high: \>160 millimeter of mercury \[mmHg\]), diastolic blood pressure (low: \<45 mmHg and high: \>100 mmHg) and body temperature (low: \<35 degree Celsius and high: \>37.5 degree Celsius). Number of participants with vital signs of PCI are presented.
Time frame: Up to 307 days
Population: Safety population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | Number of Participants With Vital Signs of PCI | 1 Participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Number of Participants With Vital Signs of PCI | 0 Participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Number of Participants With Vital Signs of PCI | 0 Participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Number of Participants With Vital Signs of PCI | 1 Participants |
| GSK2831781 0.04 mg/kg (ADA-ve) | Number of Participants With Vital Signs of PCI | 0 Participants |
| GSK2831781 0.15 mg/kg (ADA-ve) | Number of Participants With Vital Signs of PCI | 0 Participants |
| GSK2831781 0.15 mg/kg (ADA+ve) | Number of Participants With Vital Signs of PCI | 1 Participants |
| Placebo for Psoriasis | Number of Participants With Vital Signs of PCI | 1 Participants |
| GSK2831781 0.5 mg/kg | Number of Participants With Vital Signs of PCI | 0 Participants |
| GSK2831781 1.5 mg/kg | Number of Participants With Vital Signs of PCI | 1 Participants |
| GSK2831781 5 mg/kg | Number of Participants With Vital Signs of PCI | 2 Participants |
Secondary
Absolute PGA Scores in Psoriasis Participants
A 7-point scoring system was used to measure the severity of psoriatic lesions over the whole body. The score 0 indicated as clear: no signs of psoriasis and 6 indicated as severe: very marked plaque elevation, scaling and erythema.
Time frame: Baseline, Days 15, 29, 43, 85 and 121
Population: Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Absolute PGA Scores in Psoriasis Participants | Day 121 (n=9,6,6,6) | 4.1 Scores on a scale | Standard Deviation 1.36 |
| Placebo for Healthy Volunteer Combined | Absolute PGA Scores in Psoriasis Participants | Day 43 (n=9,6,6,6) | 4.0 Scores on a scale | Standard Deviation 1.12 |
| Placebo for Healthy Volunteer Combined | Absolute PGA Scores in Psoriasis Participants | Day 29 (n=9,6,6,6) | 4.1 Scores on a scale | Standard Deviation 1.05 |
| Placebo for Healthy Volunteer Combined | Absolute PGA Scores in Psoriasis Participants | Baseline (n=9,6,6,6) | 4.4 Scores on a scale | Standard Deviation 0.88 |
| Placebo for Healthy Volunteer Combined | Absolute PGA Scores in Psoriasis Participants | Day 85 (n=6,0,6,6) | 4.0 Scores on a scale | Standard Deviation 1.79 |
| Placebo for Healthy Volunteer Combined | Absolute PGA Scores in Psoriasis Participants | Day 15 (n=9,6,6,6) | 4.3 Scores on a scale | Standard Deviation 0.71 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Absolute PGA Scores in Psoriasis Participants | Baseline (n=9,6,6,6) | 3.2 Scores on a scale | Standard Deviation 0.75 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Absolute PGA Scores in Psoriasis Participants | Day 121 (n=9,6,6,6) | 3.8 Scores on a scale | Standard Deviation 1.47 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Absolute PGA Scores in Psoriasis Participants | Day 15 (n=9,6,6,6) | 2.5 Scores on a scale | Standard Deviation 1.05 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Absolute PGA Scores in Psoriasis Participants | Day 29 (n=9,6,6,6) | 2.7 Scores on a scale | Standard Deviation 0.82 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Absolute PGA Scores in Psoriasis Participants | Day 43 (n=9,6,6,6) | 3.2 Scores on a scale | Standard Deviation 0.75 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Absolute PGA Scores in Psoriasis Participants | Day 29 (n=9,6,6,6) | 4.3 Scores on a scale | Standard Deviation 1.21 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Absolute PGA Scores in Psoriasis Participants | Baseline (n=9,6,6,6) | 4.8 Scores on a scale | Standard Deviation 0.75 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Absolute PGA Scores in Psoriasis Participants | Day 15 (n=9,6,6,6) | 4.5 Scores on a scale | Standard Deviation 1.05 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Absolute PGA Scores in Psoriasis Participants | Day 121 (n=9,6,6,6) | 4.5 Scores on a scale | Standard Deviation 1.38 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Absolute PGA Scores in Psoriasis Participants | Day 85 (n=6,0,6,6) | 4.8 Scores on a scale | Standard Deviation 0.98 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Absolute PGA Scores in Psoriasis Participants | Day 43 (n=9,6,6,6) | 4.0 Scores on a scale | Standard Deviation 0.89 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Absolute PGA Scores in Psoriasis Participants | Day 121 (n=9,6,6,6) | 3.2 Scores on a scale | Standard Deviation 0.98 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Absolute PGA Scores in Psoriasis Participants | Baseline (n=9,6,6,6) | 4.2 Scores on a scale | Standard Deviation 0.98 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Absolute PGA Scores in Psoriasis Participants | Day 15 (n=9,6,6,6) | 3.2 Scores on a scale | Standard Deviation 1.17 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Absolute PGA Scores in Psoriasis Participants | Day 29 (n=9,6,6,6) | 2.8 Scores on a scale | Standard Deviation 0.75 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Absolute PGA Scores in Psoriasis Participants | Day 85 (n=6,0,6,6) | 2.7 Scores on a scale | Standard Deviation 0.52 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Absolute PGA Scores in Psoriasis Participants | Day 43 (n=9,6,6,6) | 2.7 Scores on a scale | Standard Deviation 0.52 |
Secondary
Absolute PLSS Scores for the Index Plaque
PLSS is a 0 to 12 point rating scale for lesions, calculated as the sum of the scores (ranging from 0 = no symptoms to 4 = very marked) for 3 symptoms: induration, erythema and scaling, measured by a qualified dermatologist. The PLSS score for the Index Plaque ranged from 0 to 12. The score 0 indicated no symptoms and 12 is the worst score.
Time frame: Baseline, Days 15, 29, 43, 85 and 121
Population: Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Absolute PLSS Scores for the Index Plaque | Baseline (n=9,6,6,6) | 7.1 Scores on a scale | Standard Deviation 1.05 |
| Placebo for Healthy Volunteer Combined | Absolute PLSS Scores for the Index Plaque | Day 85 (n=6,0,6,6) | 5.7 Scores on a scale | Standard Deviation 3.39 |
| Placebo for Healthy Volunteer Combined | Absolute PLSS Scores for the Index Plaque | Day 43 (n=9,6,6,6) | 6.4 Scores on a scale | Standard Deviation 2.19 |
| Placebo for Healthy Volunteer Combined | Absolute PLSS Scores for the Index Plaque | Day 15 (n=9,6,6,6) | 6.6 Scores on a scale | Standard Deviation 1.24 |
| Placebo for Healthy Volunteer Combined | Absolute PLSS Scores for the Index Plaque | Day 121 (n=9,6,6,6) | 6.2 Scores on a scale | Standard Deviation 2.54 |
| Placebo for Healthy Volunteer Combined | Absolute PLSS Scores for the Index Plaque | Day 29 (n=9,6,6,6) | 6.9 Scores on a scale | Standard Deviation 14.62 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Absolute PLSS Scores for the Index Plaque | Day 15 (n=9,6,6,6) | 5.2 Scores on a scale | Standard Deviation 1.94 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Absolute PLSS Scores for the Index Plaque | Baseline (n=9,6,6,6) | 6.5 Scores on a scale | Standard Deviation 1.38 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Absolute PLSS Scores for the Index Plaque | Day 43 (n=9,6,6,6) | 4.7 Scores on a scale | Standard Deviation 1.97 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Absolute PLSS Scores for the Index Plaque | Day 121 (n=9,6,6,6) | 6.0 Scores on a scale | Standard Deviation 1.41 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Absolute PLSS Scores for the Index Plaque | Day 29 (n=9,6,6,6) | 4.3 Scores on a scale | Standard Deviation 1.75 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Absolute PLSS Scores for the Index Plaque | Day 85 (n=6,0,6,6) | 6.5 Scores on a scale | Standard Deviation 1.05 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Absolute PLSS Scores for the Index Plaque | Baseline (n=9,6,6,6) | 7.7 Scores on a scale | Standard Deviation 1.37 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Absolute PLSS Scores for the Index Plaque | Day 15 (n=9,6,6,6) | 5.8 Scores on a scale | Standard Deviation 1.72 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Absolute PLSS Scores for the Index Plaque | Day 29 (n=9,6,6,6) | 5.8 Scores on a scale | Standard Deviation 1.72 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Absolute PLSS Scores for the Index Plaque | Day 43 (n=9,6,6,6) | 5.8 Scores on a scale | Standard Deviation 1.72 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Absolute PLSS Scores for the Index Plaque | Day 121 (n=9,6,6,6) | 6.5 Scores on a scale | Standard Deviation 1.76 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Absolute PLSS Scores for the Index Plaque | Day 29 (n=9,6,6,6) | 4.5 Scores on a scale | Standard Deviation 1.05 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Absolute PLSS Scores for the Index Plaque | Day 85 (n=6,0,6,6) | 5.0 Scores on a scale | Standard Deviation 1.67 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Absolute PLSS Scores for the Index Plaque | Day 15 (n=9,6,6,6) | 4.8 Scores on a scale | Standard Deviation 1.33 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Absolute PLSS Scores for the Index Plaque | Baseline (n=9,6,6,6) | 6.5 Scores on a scale | Standard Deviation 0.84 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Absolute PLSS Scores for the Index Plaque | Day 121 (n=9,6,6,6) | 5.8 Scores on a scale | Standard Deviation 1.17 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Absolute PLSS Scores for the Index Plaque | Day 43 (n=9,6,6,6) | 4.7 Scores on a scale | Standard Deviation 1.21 |
Secondary
Actual PASI Scores
PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head, upper extremities, trunk and lower extremities with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged from 0=No symptoms, 1=slight, 2=moderate, 3=marked and 4=very marked) of erythema, induration and scaling in each of the 4 areas. PASI score ranges from 0 (no psoriasis) to 72 (worse psoriasis). Final PASI=(sum of severity score for each area) \* (% body area affected score \* area score).
Time frame: Baseline, Days 15, 29, 43, 85 and 121
Population: Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Actual PASI Scores | Day 15 (n=9,6,6,6) | 9.6 Scores on a scale | Standard Deviation 3.92 |
| Placebo for Healthy Volunteer Combined | Actual PASI Scores | Day 121 (n=9,6,6,6) | 9.8 Scores on a scale | Standard Deviation 5.2 |
| Placebo for Healthy Volunteer Combined | Actual PASI Scores | Day 43 (n=9,6,6,6) | 8.6 Scores on a scale | Standard Deviation 3.79 |
| Placebo for Healthy Volunteer Combined | Actual PASI Scores | Day 29 (n=9,6,6,6) | 9.8 Scores on a scale | Standard Deviation 4.17 |
| Placebo for Healthy Volunteer Combined | Actual PASI Scores | Baseline (n=9,6,6,6) | 10.3 Scores on a scale | Standard Deviation 4.52 |
| Placebo for Healthy Volunteer Combined | Actual PASI Scores | Day 85 (n=6,0,6,6) | 9.4 Scores on a scale | Standard Deviation 5.94 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Actual PASI Scores | Day 29 (n=9,6,6,6) | 5.0 Scores on a scale | Standard Deviation 2.82 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Actual PASI Scores | Day 43 (n=9,6,6,6) | 5.2 Scores on a scale | Standard Deviation 2.71 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Actual PASI Scores | Day 15 (n=9,6,6,6) | 5.1 Scores on a scale | Standard Deviation 2.84 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Actual PASI Scores | Day 121 (n=9,6,6,6) | 6.3 Scores on a scale | Standard Deviation 3 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Actual PASI Scores | Baseline (n=9,6,6,6) | 6.8 Scores on a scale | Standard Deviation 2.4 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Actual PASI Scores | Day 29 (n=9,6,6,6) | 10.8 Scores on a scale | Standard Deviation 4.14 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Actual PASI Scores | Day 121 (n=9,6,6,6) | 15.4 Scores on a scale | Standard Deviation 8.59 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Actual PASI Scores | Day 15 (n=9,6,6,6) | 11.7 Scores on a scale | Standard Deviation 5.67 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Actual PASI Scores | Day 85 (n=6,0,6,6) | 15.4 Scores on a scale | Standard Deviation 6.73 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Actual PASI Scores | Day 43 (n=9,6,6,6) | 10.4 Scores on a scale | Standard Deviation 4.06 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Actual PASI Scores | Baseline (n=9,6,6,6) | 14.1 Scores on a scale | Standard Deviation 6.55 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Actual PASI Scores | Day 121 (n=9,6,6,6) | 6.5 Scores on a scale | Standard Deviation 3.76 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Actual PASI Scores | Baseline (n=9,6,6,6) | 9.2 Scores on a scale | Standard Deviation 4.09 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Actual PASI Scores | Day 15 (n=9,6,6,6) | 6.5 Scores on a scale | Standard Deviation 2.98 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Actual PASI Scores | Day 29 (n=9,6,6,6) | 5.7 Scores on a scale | Standard Deviation 2.54 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Actual PASI Scores | Day 43 (n=9,6,6,6) | 5.5 Scores on a scale | Standard Deviation 2.2 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Actual PASI Scores | Day 85 (n=6,0,6,6) | 5.9 Scores on a scale | Standard Deviation 2.39 |
Secondary
Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-t]) for GSK2831781 0.0003 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose
Population: PK population. Data was not collected because none of the participants had data evaluable for this measure.
Secondary
Area Under the Concentration-time Curve From Zero (Pre-dose) to Week 4 (AUC[0-Week 4]) for GSK2831781 0.0003 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24 and 696 (Week 4) hours post-dose
Population: PK population. Data was not collected because none of the participants had data evaluable for this measure.
Secondary
Area Under the Plasma Time Curve From Zero to Infinity (AUC[0-infinity]) of GSK2831781 0.0003 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma. Pharmacokinetic (PK) population consisted of all participants in the Safety Population who had at least 1 non-missing PK assessment.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose
Population: PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).
Secondary
AUC(0-infinity) for GSK2831781 0.0015 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Population: PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).
Secondary
AUC(0-infinity) for GSK2831781 0.0075 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose
Population: PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).
Secondary
AUC(0-infinity) for GSK2831781 0.04 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose
Population: PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).
Secondary
AUC(0-infinity) for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose
Population: PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).
Secondary
AUC(0-infinity) for GSK2831781 0.5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose
Population: PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).
Secondary
AUC(0-infinity) for GSK2831781 1.5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose
Population: PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).
Secondary
AUC(0-infinity) for GSK2831781 5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose
Population: PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).
Secondary
AUC(0-t) for GSK2831781 0.0015 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | AUC(0-t) for GSK2831781 0.0015 mg/kg (ADA-ve) | 0.0060 h*mcg/mL |
Secondary
AUC(0-t) for GSK2831781 0.0075 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | AUC(0-t) for GSK2831781 0.0075 mg/kg (ADA-ve) | 1.3497 h*mcg/mL | Geometric Coefficient of Variation 31.95218 |
Secondary
AUC(0-t) for GSK2831781 0.04 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | AUC(0-t) for GSK2831781 0.04 mg/kg (ADA-ve) | 23.6008 h*mcg/mL | Geometric Coefficient of Variation 27.26266 |
Secondary
AUC(0-t) for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | AUC(0-t) for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve) | 168.3458 h*mcg/mL | Geometric Coefficient of Variation 18.00654 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | AUC(0-t) for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve) | 238.1434 h*mcg/mL | Geometric Coefficient of Variation 43.68332 |
Secondary
AUC(0-t) for GSK2831781 0.5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | AUC(0-t) for GSK2831781 0.5 mg/kg | 1187.8496 h*mcg/mL | Geometric Coefficient of Variation 34.15549 |
Secondary
AUC(0-t) for GSK2831781 1.5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | AUC(0-t) for GSK2831781 1.5 mg/kg | 8493.7344 h*mcg/mL | Geometric Coefficient of Variation 13.62279 |
Secondary
AUC(0-t) for GSK2831781 5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | AUC(0-t) for GSK2831781 5 mg/kg | 40599.8938 h*mcg/mL | Geometric Coefficient of Variation 23.74167 |
Secondary
AUC(0-Week 4) for GSK2831781 0.0015 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 696 (Week 4) hours post-dose
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | AUC(0-Week 4) for GSK2831781 0.0015 mg/kg (ADA-ve) | NA h*mcg/mL |
Secondary
AUC(0-Week 4) for GSK2831781 0.0075 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15 and 29 (Week 4) post-dose
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | AUC(0-Week 4) for GSK2831781 0.0075 mg/kg (ADA-ve) | NA h*mcg/mL |
Secondary
AUC(0-Week 4) for GSK2831781 0.04 mg/kg (ADA-ve)
Blood samples were collected at specified time point for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22 and 29 (Week 4) post-dose
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | AUC(0-Week 4) for GSK2831781 0.04 mg/kg (ADA-ve) | NA h*mcg/mL |
Secondary
AUC(0-Week 4) for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22 and 29 (Week 4) post-dose
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | AUC(0-Week 4) for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve) | NA h*mcg/mL |
| GSK2831781 0.0003 mg/kg (ADA-ve) | AUC(0-Week 4) for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve) | NA h*mcg/mL |
Secondary
AUC(0-Week 4) for GSK2831781 0.5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22 and 29 (Week 4) post-dose
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | AUC(0-Week 4) for GSK2831781 0.5 mg/kg | NA h*mcg/mL |
Secondary
AUC(0-Week 4) for GSK2831781 1.5 mg/kg
Blood samples were collected at specified time point for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22 and 29 (Week 4) post-dose
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | AUC(0-Week 4) for GSK2831781 1.5 mg/kg | NA h*mcg/mL |
Secondary
AUC(0-Week 4) for GSK2831781 5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22 and 29 (Week 4) post-dose
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | AUC(0-Week 4) for GSK2831781 5 mg/kg | NA h*mcg/mL |
Secondary
%AUCex for GSK2831781 0.0015 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Population: PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.
Secondary
%AUCex for GSK2831781 0.0075 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose
Population: PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.
Secondary
%AUCex for GSK2831781 0.04 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose
Population: PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.
Secondary
%AUCex for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose
Population: PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.
Secondary
%AUCex for GSK2831781 0.5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose
Population: PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.
Secondary
%AUCex for GSK2831781 1.5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose
Population: PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.
Secondary
%AUCex for GSK2831781 5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose
Population: PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.
Secondary
Change From Baseline in LAG-3+ Cells in Lesional Biopsies in Psoriasis Participants at Day 29
A punch biopsy was taken from active leading edge of the lesion. Cells in lesional biopsies of skin were measured by IHC and count the LAG-3+ cells. The regions of interest for LAG3+ were located in epidermis and dermis. Baseline was considered as the latest pre-dose assessment with a non-missing value for Day -1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Time frame: Baseline and Day 29
Population: Safety population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Change From Baseline in LAG-3+ Cells in Lesional Biopsies in Psoriasis Participants at Day 29 | Skin: Dermis (n=6,4,3,4) | 2.7 LAG3+ cells | Standard Deviation 6.09 |
| Placebo for Healthy Volunteer Combined | Change From Baseline in LAG-3+ Cells in Lesional Biopsies in Psoriasis Participants at Day 29 | Skin: Epidermis (n=6,4,4,5) | -1.2 LAG3+ cells | Standard Deviation 12.86 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in LAG-3+ Cells in Lesional Biopsies in Psoriasis Participants at Day 29 | Skin: Epidermis (n=6,4,4,5) | -9.8 LAG3+ cells | Standard Deviation 15.11 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in LAG-3+ Cells in Lesional Biopsies in Psoriasis Participants at Day 29 | Skin: Dermis (n=6,4,3,4) | -2.5 LAG3+ cells | Standard Deviation 3.7 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in LAG-3+ Cells in Lesional Biopsies in Psoriasis Participants at Day 29 | Skin: Dermis (n=6,4,3,4) | 0.3 LAG3+ cells | Standard Deviation 2.08 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in LAG-3+ Cells in Lesional Biopsies in Psoriasis Participants at Day 29 | Skin: Epidermis (n=6,4,4,5) | -6.5 LAG3+ cells | Standard Deviation 6.45 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in LAG-3+ Cells in Lesional Biopsies in Psoriasis Participants at Day 29 | Skin: Dermis (n=6,4,3,4) | -2.5 LAG3+ cells | Standard Deviation 2.38 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in LAG-3+ Cells in Lesional Biopsies in Psoriasis Participants at Day 29 | Skin: Epidermis (n=6,4,4,5) | -5.0 LAG3+ cells | Standard Deviation 6.89 |
Secondary
Change From Baseline in Physicians Global Assessment (PGA) Scores in Psoriasis Participants
A 7-point scoring system was used to measure the severity of psoriatic lesions over the whole body. The score 0 indicated as clear: no signs of psoriasis and 6 indicated as severe: very marked plaque elevation, scaling and erythema. Baseline was considered as the latest pre-dose assessment with a non-missing value for Day -1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Time frame: Baseline, Days 15, 29, 43, 85 and 121
Population: Safety population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Change From Baseline in Physicians Global Assessment (PGA) Scores in Psoriasis Participants | Day 121 (n=9,6,6,6) | -0.3 Scores on a scale | Standard Deviation 1.5 |
| Placebo for Healthy Volunteer Combined | Change From Baseline in Physicians Global Assessment (PGA) Scores in Psoriasis Participants | Day 15 (n=9,6,6,6) | -0.1 Scores on a scale | Standard Deviation 1.05 |
| Placebo for Healthy Volunteer Combined | Change From Baseline in Physicians Global Assessment (PGA) Scores in Psoriasis Participants | Day 43 (n=9,6,6,6) | -0.4 Scores on a scale | Standard Deviation 1.59 |
| Placebo for Healthy Volunteer Combined | Change From Baseline in Physicians Global Assessment (PGA) Scores in Psoriasis Participants | Day 85 (n=6,0,6,6) | -0.7 Scores on a scale | Standard Deviation 2.07 |
| Placebo for Healthy Volunteer Combined | Change From Baseline in Physicians Global Assessment (PGA) Scores in Psoriasis Participants | Day 29 (n=9,6,6,6) | -0.3 Scores on a scale | Standard Deviation 1.58 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in Physicians Global Assessment (PGA) Scores in Psoriasis Participants | Day 43 (n=9,6,6,6) | 0.0 Scores on a scale | Standard Deviation 0.89 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in Physicians Global Assessment (PGA) Scores in Psoriasis Participants | Day 15 (n=9,6,6,6) | -0.7 Scores on a scale | Standard Deviation 0.82 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in Physicians Global Assessment (PGA) Scores in Psoriasis Participants | Day 29 (n=9,6,6,6) | -0.5 Scores on a scale | Standard Deviation 0.84 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in Physicians Global Assessment (PGA) Scores in Psoriasis Participants | Day 121 (n=9,6,6,6) | 0.7 Scores on a scale | Standard Deviation 1.75 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Physicians Global Assessment (PGA) Scores in Psoriasis Participants | Day 43 (n=9,6,6,6) | -0.8 Scores on a scale | Standard Deviation 0.98 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Physicians Global Assessment (PGA) Scores in Psoriasis Participants | Day 15 (n=9,6,6,6) | -0.3 Scores on a scale | Standard Deviation 0.82 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Physicians Global Assessment (PGA) Scores in Psoriasis Participants | Day 85 (n=6,0,6,6) | 0.0 Scores on a scale | Standard Deviation 0.89 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Physicians Global Assessment (PGA) Scores in Psoriasis Participants | Day 121 (n=9,6,6,6) | -0.3 Scores on a scale | Standard Deviation 1.21 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Physicians Global Assessment (PGA) Scores in Psoriasis Participants | Day 29 (n=9,6,6,6) | -0.5 Scores on a scale | Standard Deviation 1.05 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Physicians Global Assessment (PGA) Scores in Psoriasis Participants | Day 29 (n=9,6,6,6) | -1.3 Scores on a scale | Standard Deviation 1.03 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Physicians Global Assessment (PGA) Scores in Psoriasis Participants | Day 43 (n=9,6,6,6) | -1.5 Scores on a scale | Standard Deviation 0.55 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Physicians Global Assessment (PGA) Scores in Psoriasis Participants | Day 15 (n=9,6,6,6) | -1.0 Scores on a scale | Standard Deviation 0.63 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Physicians Global Assessment (PGA) Scores in Psoriasis Participants | Day 85 (n=6,0,6,6) | -1.5 Scores on a scale | Standard Deviation 0.55 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Physicians Global Assessment (PGA) Scores in Psoriasis Participants | Day 121 (n=9,6,6,6) | -1.0 Scores on a scale | Standard Deviation 0 |
Secondary
Change From Baseline in Plaque Lesional Severity Score (PLSS) Scores for the Index Plaque
PLSS is a 0 to 12 point rating scale for lesions, calculated as the sum of the scores (ranging from 0 = no symptoms to 4 = very marked) for 3 symptoms: induration, erythema and scaling, measured by a qualified dermatologist. The PLSS score for the Index Plaque ranged from 0 to 12. The score 0 indicated no symptoms and 12 is the worst score. Baseline was considered as the latest pre-dose assessment with a non-missing value for Day -1. Change from Baseline was calculated as post-Baseline value minus Baseline value. A negative change from Baseline is an improvement in symptoms.
Time frame: Baseline, Days 15, 29, 43, 85 and 121
Population: Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Change From Baseline in Plaque Lesional Severity Score (PLSS) Scores for the Index Plaque | Day 121 (n=9,6,6,6) | -0.9 Scores on a scale | Standard Deviation 2.42 |
| Placebo for Healthy Volunteer Combined | Change From Baseline in Plaque Lesional Severity Score (PLSS) Scores for the Index Plaque | Day 15 (n=9,6,6,6) | -0.6 Scores on a scale | Standard Deviation 1.24 |
| Placebo for Healthy Volunteer Combined | Change From Baseline in Plaque Lesional Severity Score (PLSS) Scores for the Index Plaque | Day 43 (n=9,6,6,6) | -0.7 Scores on a scale | Standard Deviation 2 |
| Placebo for Healthy Volunteer Combined | Change From Baseline in Plaque Lesional Severity Score (PLSS) Scores for the Index Plaque | Day 85 (n=6,0,6,6) | -1.7 Scores on a scale | Standard Deviation 2.42 |
| Placebo for Healthy Volunteer Combined | Change From Baseline in Plaque Lesional Severity Score (PLSS) Scores for the Index Plaque | Day 29 (n=9,6,6,6) | -0.2 Scores on a scale | Standard Deviation 1.79 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in Plaque Lesional Severity Score (PLSS) Scores for the Index Plaque | Day 43 (n=9,6,6,6) | -1.8 Scores on a scale | Standard Deviation 1.17 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in Plaque Lesional Severity Score (PLSS) Scores for the Index Plaque | Day 15 (n=9,6,6,6) | -1.3 Scores on a scale | Standard Deviation 1.03 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in Plaque Lesional Severity Score (PLSS) Scores for the Index Plaque | Day 29 (n=9,6,6,6) | -2.2 Scores on a scale | Standard Deviation 1.33 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in Plaque Lesional Severity Score (PLSS) Scores for the Index Plaque | Day 121 (n=9,6,6,6) | -0.5 Scores on a scale | Standard Deviation 1.38 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Plaque Lesional Severity Score (PLSS) Scores for the Index Plaque | Day 43 (n=9,6,6,6) | -1.8 Scores on a scale | Standard Deviation 1.47 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Plaque Lesional Severity Score (PLSS) Scores for the Index Plaque | Day 15 (n=9,6,6,6) | -1.8 Scores on a scale | Standard Deviation 1.47 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Plaque Lesional Severity Score (PLSS) Scores for the Index Plaque | Day 85 (n=6,0,6,6) | -1.2 Scores on a scale | Standard Deviation 2.04 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Plaque Lesional Severity Score (PLSS) Scores for the Index Plaque | Day 121 (n=9,6,6,6) | -1.2 Scores on a scale | Standard Deviation 2.64 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Plaque Lesional Severity Score (PLSS) Scores for the Index Plaque | Day 29 (n=9,6,6,6) | -1.8 Scores on a scale | Standard Deviation 1.47 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Plaque Lesional Severity Score (PLSS) Scores for the Index Plaque | Day 29 (n=9,6,6,6) | -2.0 Scores on a scale | Standard Deviation 0.89 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Plaque Lesional Severity Score (PLSS) Scores for the Index Plaque | Day 43 (n=9,6,6,6) | -1.8 Scores on a scale | Standard Deviation 1.17 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Plaque Lesional Severity Score (PLSS) Scores for the Index Plaque | Day 15 (n=9,6,6,6) | -1.7 Scores on a scale | Standard Deviation 1.03 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Plaque Lesional Severity Score (PLSS) Scores for the Index Plaque | Day 85 (n=6,0,6,6) | -1.5 Scores on a scale | Standard Deviation 1.64 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Plaque Lesional Severity Score (PLSS) Scores for the Index Plaque | Day 121 (n=9,6,6,6) | -0.7 Scores on a scale | Standard Deviation 1.63 |
Secondary
Change From Baseline in Psoriasis Area Severity Index (PASI) Scores
PASI score was determined by evaluation of body surface area (BSA) covered by plaque psoriasis in 4 areas (head, upper extremities, trunk and lower extremities with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged from 0=No symptoms, 1=slight, 2=moderate, 3=marked and 4=very marked) of erythema, induration and scaling in each of the 4 areas. PASI score ranges from 0 (no psoriasis) to 72 (worse psoriasis). Final PASI=(sum of severity score for each area) \* (% body area affected score \* area score). Baseline was considered as the latest pre-dose assessment with a non-missing value for Day -1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Time frame: Baseline, Days 15, 29, 43, 85 and 121
Population: Safety population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Change From Baseline in Psoriasis Area Severity Index (PASI) Scores | Day 43 (n=9,6,6,6) | -1.7 Scores on a scale | Standard Deviation 4.12 |
| Placebo for Healthy Volunteer Combined | Change From Baseline in Psoriasis Area Severity Index (PASI) Scores | Day 15 (n=9,6,6,6) | -0.7 Scores on a scale | Standard Deviation 2.66 |
| Placebo for Healthy Volunteer Combined | Change From Baseline in Psoriasis Area Severity Index (PASI) Scores | Day 85 (n=6,0,6,6) | -1.0 Scores on a scale | Standard Deviation 6.09 |
| Placebo for Healthy Volunteer Combined | Change From Baseline in Psoriasis Area Severity Index (PASI) Scores | Day 29 (n=9,6,6,6) | -0.5 Scores on a scale | Standard Deviation 3.09 |
| Placebo for Healthy Volunteer Combined | Change From Baseline in Psoriasis Area Severity Index (PASI) Scores | Day 121 (n=9,6,6,6) | -0.6 Scores on a scale | Standard Deviation 3.03 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in Psoriasis Area Severity Index (PASI) Scores | Day 43 (n=9,6,6,6) | -1.6 Scores on a scale | Standard Deviation 2.4 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in Psoriasis Area Severity Index (PASI) Scores | Day 15 (n=9,6,6,6) | -1.7 Scores on a scale | Standard Deviation 2.43 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in Psoriasis Area Severity Index (PASI) Scores | Day 29 (n=9,6,6,6) | -1.8 Scores on a scale | Standard Deviation 2.25 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline in Psoriasis Area Severity Index (PASI) Scores | Day 121 (n=9,6,6,6) | -0.5 Scores on a scale | Standard Deviation 2.44 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Psoriasis Area Severity Index (PASI) Scores | Day 85 (n=6,0,6,6) | 1.2 Scores on a scale | Standard Deviation 3.75 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Psoriasis Area Severity Index (PASI) Scores | Day 15 (n=9,6,6,6) | -2.4 Scores on a scale | Standard Deviation 2.56 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Psoriasis Area Severity Index (PASI) Scores | Day 29 (n=9,6,6,6) | -3.3 Scores on a scale | Standard Deviation 4.53 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Psoriasis Area Severity Index (PASI) Scores | Day 43 (n=9,6,6,6) | -3.8 Scores on a scale | Standard Deviation 4.36 |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Change From Baseline in Psoriasis Area Severity Index (PASI) Scores | Day 121 (n=9,6,6,6) | 1.2 Scores on a scale | Standard Deviation 5.83 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Psoriasis Area Severity Index (PASI) Scores | Day 85 (n=6,0,6,6) | -3.3 Scores on a scale | Standard Deviation 2.55 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Psoriasis Area Severity Index (PASI) Scores | Day 29 (n=9,6,6,6) | -3.5 Scores on a scale | Standard Deviation 2.93 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Psoriasis Area Severity Index (PASI) Scores | Day 15 (n=9,6,6,6) | -2.7 Scores on a scale | Standard Deviation 2.54 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Psoriasis Area Severity Index (PASI) Scores | Day 121 (n=9,6,6,6) | -2.7 Scores on a scale | Standard Deviation 2.21 |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Change From Baseline in Psoriasis Area Severity Index (PASI) Scores | Day 43 (n=9,6,6,6) | -3.7 Scores on a scale | Standard Deviation 2.66 |
Secondary
Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose
The induration diameter by challenge site is defined as the average of the two skin response test values (vertical and horizontal) at each challenge site. A challenge site is defined by skin response (SR) directionality (upper/lower) and SR laterality (left/right). Four categories considered were as follows: left upper, right upper, left lower and right lower. Baseline was considered as Day -26. Change from Baseline was calculated as post-Baseline value minus Baseline value. Data is presented for DTH participants.
Time frame: Baseline, Days 4, 8, 15 and 22 post-dose
Population: Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose | Day 8: Right upper average (n=6,5) | -0.917 Millimeter (mm) | Standard Deviation 7.8065 |
| Placebo for Healthy Volunteer Combined | Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose | Day 4: Left upper average (n=6,6) | 3.167 Millimeter (mm) | Standard Deviation 1.8886 |
| Placebo for Healthy Volunteer Combined | Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose | Day 4: Right upper average (n=6,6) | 2.000 Millimeter (mm) | Standard Deviation 4.2426 |
| Placebo for Healthy Volunteer Combined | Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose | Day 8: Left upper average (n=5,3) | 0.300 Millimeter (mm) | Standard Deviation 4.4805 |
| Placebo for Healthy Volunteer Combined | Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose | Day 15: Left upper average (n=5,3) | -7.500 Millimeter (mm) | Standard Deviation 10.943 |
| Placebo for Healthy Volunteer Combined | Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose | Day 15: Right upper average (n=6,5) | -9.000 Millimeter (mm) | Standard Deviation 9.8894 |
| Placebo for Healthy Volunteer Combined | Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose | Day 22: Left upper average (n=5,3) | -11.600 Millimeter (mm) | Standard Deviation 8.9121 |
| Placebo for Healthy Volunteer Combined | Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose | Day 22: Right upper average (n=6,5) | -14.083 Millimeter (mm) | Standard Deviation 10.4231 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose | Day 22: Right upper average (n=6,5) | -8.900 Millimeter (mm) | Standard Deviation 9.7877 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose | Day 15: Left upper average (n=5,3) | -3.333 Millimeter (mm) | Standard Deviation 7.2342 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose | Day 4: Left upper average (n=6,6) | 6.500 Millimeter (mm) | Standard Deviation 4.5497 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose | Day 22: Left upper average (n=5,3) | -11.833 Millimeter (mm) | Standard Deviation 7.1122 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose | Day 4: Right upper average (n=6,6) | 6.500 Millimeter (mm) | Standard Deviation 4.3359 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose | Day 15: Right upper average (n=6,5) | -5.800 Millimeter (mm) | Standard Deviation 2.9283 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose | Day 8: Left upper average (n=5,3) | 2.167 Millimeter (mm) | Standard Deviation 5.0083 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose | Day 8: Right upper average (n=6,5) | -0.700 Millimeter (mm) | Standard Deviation 4.2367 |
Secondary
Change From Baseline (PPD First Challenge) of Lymphocyte Activation Gene-3 (LAG-3)+ Cells in Biopsies of Re-challenged Skin at 3 Days Post-dose
A punch biopsy was taken from one of the challenge sites. Cells in biopsies of re-challenged skin were measured by immunohistochemistry (IHC) and the LAG-3+ cells characterized and counted. Baseline was considered as Day -26 for this outcome measure. Change from Baseline was calculated as post-Baseline value minus Baseline value. Data is presented for DTH participants.
Time frame: Baseline and 72 hours post-dose
Population: Safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Change From Baseline (PPD First Challenge) of Lymphocyte Activation Gene-3 (LAG-3)+ Cells in Biopsies of Re-challenged Skin at 3 Days Post-dose | 15.3 LAG3+ cells | Standard Deviation 24.9 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Change From Baseline (PPD First Challenge) of Lymphocyte Activation Gene-3 (LAG-3)+ Cells in Biopsies of Re-challenged Skin at 3 Days Post-dose | 19.7 LAG3+ cells | Standard Deviation 18.1 |
Secondary
CL for GSK2831781 0.0015 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Population: PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.
Secondary
CL for GSK2831781 0.0075 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose
Population: PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.
Secondary
CL for GSK2831781 0.04 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose
Population: PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.
Secondary
CL for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose
Population: PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.
Secondary
CL for GSK2831781 0.5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose
Population: PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.
Secondary
CL for GSK2831781 1.5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose
Population: PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.
Secondary
CL for GSK2831781 5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose
Population: PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.
Secondary
Cmax for GSK2831781 0.0015 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | Cmax for GSK2831781 0.0015 mg/kg (ADA-ve) | 0.0127 mcg/mL |
Secondary
Cmax for GSK2831781 0.0075 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Cmax for GSK2831781 0.0075 mg/kg (ADA-ve) | 0.1523 mcg/mL | Geometric Coefficient of Variation 19.07315 |
Secondary
Cmax for GSK2831781 0.04 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Cmax for GSK2831781 0.04 mg/kg (ADA-ve) | 0.8196 mcg/mL | Geometric Coefficient of Variation 25.57947 |
Secondary
Cmax for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Cmax for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve) | 3.0047 mcg/mL | Geometric Coefficient of Variation 17.41022 |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Cmax for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve) | 3.4255 mcg/mL | Geometric Coefficient of Variation 18.07808 |
Secondary
Cmax for GSK2831781 0.5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Cmax for GSK2831781 0.5 mg/kg | 8.4810 mcg/mL | Geometric Coefficient of Variation 23.51712 |
Secondary
Cmax for GSK2831781 1.5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Cmax for GSK2831781 1.5 mg/kg | 41.1481 mcg/mL | Geometric Coefficient of Variation 15.53659 |
Secondary
Cmax for GSK2831781 5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Cmax for GSK2831781 5 mg/kg | 158.8243 mcg/mL | Geometric Coefficient of Variation 22.2217 |
Secondary
Duration of Induration in the Re-challenge for DTH
The duration of induration was the time (in days) to achieve an overall induration less than 6 mm from the time of the PPD re-challenge post-dose. Duration of induration was calculated as: PPD re-challenge post-dose up to the last available induration measurement. Data is presented for DTH participants.
Time frame: Up to 28 days post-dose
Population: Safety population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | Duration of Induration in the Re-challenge for DTH | 20.0 Days |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Duration of Induration in the Re-challenge for DTH | 20.0 Days |
Secondary
Lambda z for GSK2831781 0.0015 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Population: PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.
Secondary
Lambda z for GSK2831781 0.0075 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose
Population: PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.
Secondary
Lambda z for GSK2831781 0.04 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose
Population: PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.
Secondary
Lambda z for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose
Population: PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.
Secondary
Lambda z for GSK2831781 0.5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose
Population: PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.
Secondary
Lambda z for GSK2831781 1.5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose
Population: PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.
Secondary
Lambda z for GSK2831781 5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose
Population: PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.
Secondary
Maximum Observed Concentration (Cmax) for GSK2831781 0.0003 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | Maximum Observed Concentration (Cmax) for GSK2831781 0.0003 mg/kg (ADA-ve) | NA mcg/mL |
Secondary
Mean Residence Time (MRT) for GSK2831781 0.0003 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose
Population: PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.
Secondary
MRT for GSK2831781 0.0015 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Population: PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.
Secondary
MRT for GSK2831781 0.0075 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose
Population: PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.
Secondary
MRT for GSK2831781 0.04 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose
Population: PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.
Secondary
MRT for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose
Population: PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.
Secondary
MRT for GSK2831781 0.5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose
Population: PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.
Secondary
MRT for GSK2831781 1.5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose
Population: PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.
Secondary
MRT for GSK2831781 5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose
Population: PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.
Secondary
Number of Participants With Positive ADAs to GSK2831781 0.0003 mg/kg (ADA-ve)
Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.
Time frame: Pre-dose (Day 1), 168 hours, and follow-up (Day 29)
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.0003 mg/kg (ADA-ve) | Pre-dose | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.0003 mg/kg (ADA-ve) | 168 hours | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.0003 mg/kg (ADA-ve) | Follow-up (Day 29) | 0 Participants |
Secondary
Number of Participants With Positive ADAs to GSK2831781 0.0015 mg/kg (ADA-ve)
Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.
Time frame: Pre-dose (Day 1), 168 hours, Days 29 and follow-up (Day 43)
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.0015 mg/kg (ADA-ve) | Pre-dose | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.0015 mg/kg (ADA-ve) | 168 hours | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.0015 mg/kg (ADA-ve) | Day 29 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.0015 mg/kg (ADA-ve) | Follow-up (Day 43) | 0 Participants |
Secondary
Number of Participants With Positive ADAs to GSK2831781 0.0075 mg/kg (ADA-ve)
Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.
Time frame: Pre-dose (Day 1), 168 hours, Days 29 and follow-up (Day 85)
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.0075 mg/kg (ADA-ve) | Follow-up (Day 85) | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.0075 mg/kg (ADA-ve) | Pre-dose | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.0075 mg/kg (ADA-ve) | 168 hours | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.0075 mg/kg (ADA-ve) | Day 29 | 1 Participants |
Secondary
Number of Participants With Positive ADAs to GSK2831781 0.04 mg/kg (ADA-ve)
Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.
Time frame: Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 147)
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.04 mg/kg (ADA-ve) | Pre-dose | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.04 mg/kg (ADA-ve) | 168 hours | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.04 mg/kg (ADA-ve) | Day 29 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.04 mg/kg (ADA-ve) | Day 85 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.04 mg/kg (ADA-ve) | Follow-up (Day 147) | 0 Participants |
Secondary
Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA-ve)
Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.
Time frame: Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 219)
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA-ve) | Pre-dose | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA-ve) | 168 hours | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA-ve) | Day 29 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA-ve) | Day 85 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA-ve) | Follow-up (Day 219) | 0 Participants |
Secondary
Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA+ve)
Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.
Time frame: Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 191)
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA+ve) | Pre-dose | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA+ve) | 168 hours | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA+ve) | Day 29 | 6 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA+ve) | Day 85 | 4 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA+ve) | Follow-up (Day 191) | 4 Participants |
Secondary
Number of Participants With Positive ADAs to GSK2831781 0.5 mg/kg
Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.
Time frame: Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 237)
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.5 mg/kg | Pre-dose | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.5 mg/kg | 168 hours | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.5 mg/kg | Day 29 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.5 mg/kg | Day 85 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 0.5 mg/kg | Follow-up (Day 237) | 1 Participants |
Secondary
Number of Participants With Positive ADAs to GSK2831781 1.5 mg/kg
Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.
Time frame: Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 277)
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 1.5 mg/kg | Day 85 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 1.5 mg/kg | Pre-dose | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 1.5 mg/kg | 168 hours | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 1.5 mg/kg | Day 29 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 1.5 mg/kg | Follow-up (Day 277) | 1 Participants |
Secondary
Number of Participants With Positive ADAs to GSK2831781 5 mg/kg
Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.
Time frame: Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 307)
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 5 mg/kg | Pre-dose | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 5 mg/kg | 168 hours | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 5 mg/kg | Day 29 | 0 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 5 mg/kg | Day 85 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 5 mg/kg | Follow-up (Day 307) | 1 Participants |
Secondary
Number of Participants With Positive ADAs to GSK2831781 in Healthy Volunteer Placebo
Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.
Time frame: Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 191)
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 in Healthy Volunteer Placebo | Pre-dose | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 in Healthy Volunteer Placebo | 168 hours | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 in Healthy Volunteer Placebo | Day 29 | 3 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 in Healthy Volunteer Placebo | Day 85 | 2 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 in Healthy Volunteer Placebo | Follow-up (Day 191) | 1 Participants |
Secondary
Number of Participants With Positive ADAs to GSK2831781 Placebo in Psoriasis Participants
Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.
Time frame: Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 307)
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 Placebo in Psoriasis Participants | 168 hours | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 Placebo in Psoriasis Participants | Day 29 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 Placebo in Psoriasis Participants | Day 85 | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 Placebo in Psoriasis Participants | Follow-up (Day 307) | 1 Participants |
| Placebo for Healthy Volunteer Combined | Number of Participants With Positive ADAs to GSK2831781 Placebo in Psoriasis Participants | Pre-dose | 1 Participants |
Secondary
Percentage of AUC(0-infinity) Obtained by Extrapolation (%AUCex) for GSK2831781 0.0003 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose
Population: PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.
Secondary
Percentage of Participants in Each PGA Score Category
A 7-point scoring system was used to measure the severity of psoriatic lesions over the whole body. The score 0=clear, 1=almost clear, 2=mild, 3=mild to moderate, 4=moderate, 5=moderate to severe and 6=severe.
Time frame: Baseline, Days 15, 29, 43, 85 and 121
Population: Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day121:Mild (n=9,6,6,6) | 0 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day29:Moderate (n=9,6,6,6) | 33 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day29:Severe (n=9,6,6,6) | 11 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day43:Moderate to severe(n=9,6,6,6) | 22 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day43:Almost clear(n=9,6,6,6) | 0 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day43:Mild (n=9,6,6,6) | 0 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day43:Moderate (n=9,6,6,6) | 22 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day43:Mild to moderate(n=9,6,6,6) | 44 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Baseline:Mild (n=9,6,6,6) | 0 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Baseline:Moderate (n=9,6,6,6) | 44 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day121:Moderate (n=9,6,6,6) | 22 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Baseline:Mild to moderate(n=9,6,6,6) | 11 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day121:Severe (n=9,6,6,6) | 0 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Baseline:Moderate to sever(n=9,6,6,6) | 33 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day121:Mild to moderate(n=9,6,6,6) | 11 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Baseline:Severe (n=9,6,6,6) | 11 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day15:Mild (n=9,6,6,6) | 0 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day15:Mild to moderate(n=9,6,6,6) | 11 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day15:Moderate (n=9,6,6,6) | 44 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day121:Almost clear(n=9,6,6,6) | 11 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day15:Moderate to severe(n=9,6,6,6) | 44 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day85:Mild (n=6,0,6,6) | 0 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day85:Severe (n=6,0,6,6) | 17 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day15:Severe (n=9,6,6,6) | 0 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day85:Moderate to severe(n=6,0,6,6) | 33 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day29:Almost clear(n=9,6,6,6) | 0 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day15:Almost clear(n=9,6,6,6) | 0 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day85:Moderate (n=6,0,6,6) | 17 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day29:Mild (n=9,6,6,6) | 0 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day85:Mild to moderate(n=6,0,6,6) | 17 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day29:Mild to moderate(n=9,6,6,6) | 33 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day85:Almost clear(n=6,0,6,6) | 17 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day121:Moderate to severe(n=9,6,6,6) | 56 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day29:Moderate to severe(n=9,6,6,6) | 22 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Baseline:Almost clear(n=9,6,6,6) | 0 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants in Each PGA Score Category | Day43:Severe (n=9,6,6,6) | 11 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day29:Moderate (n=9,6,6,6) | 17 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Baseline:Moderate to sever(n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day43:Severe (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day15:Severe (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day29:Moderate to severe(n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day29:Mild (n=9,6,6,6) | 50 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day121:Moderate to severe(n=9,6,6,6) | 33 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Baseline:Severe (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day29:Severe (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Baseline:Almost clear(n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day15:Moderate to severe(n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day15:Mild (n=9,6,6,6) | 33 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day43:Almost clear(n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day15:Almost clear(n=9,6,6,6) | 17 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day43:Moderate (n=9,6,6,6) | 33 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Baseline:Mild to moderate(n=9,6,6,6) | 50 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day43:Mild (n=9,6,6,6) | 17 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day121:Moderate (n=9,6,6,6) | 50 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day121:Mild (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day29:Mild to moderate(n=9,6,6,6) | 33 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day43:Mild to moderate(n=9,6,6,6) | 50 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day15:Mild to moderate(n=9,6,6,6) | 33 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Baseline:Mild (n=9,6,6,6) | 17 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day43:Moderate to severe(n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day121:Almost clear(n=9,6,6,6) | 17 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day29:Almost clear(n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Baseline:Moderate (n=9,6,6,6) | 33 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day15:Moderate (n=9,6,6,6) | 17 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day121:Mild to moderate(n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day121:Severe (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day121:Severe (n=9,6,6,6) | 33 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Baseline:Mild to moderate(n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Baseline:Severe (n=9,6,6,6) | 17 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day15:Almost clear(n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day15:Severe (n=9,6,6,6) | 17 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day43:Moderate to severe(n=9,6,6,6) | 33 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day85:Mild (n=6,0,6,6) | 0 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Baseline:Almost clear(n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Baseline:Mild (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Baseline:Moderate (n=9,6,6,6) | 33 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Baseline:Moderate to sever(n=9,6,6,6) | 50 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day15:Mild (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day15:Mild to moderate(n=9,6,6,6) | 17 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day15:Moderate (n=9,6,6,6) | 33 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day15:Moderate to severe(n=9,6,6,6) | 33 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day29:Almost clear(n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day29:Mild (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day29:Mild to moderate(n=9,6,6,6) | 33 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day29:Moderate (n=9,6,6,6) | 17 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day29:Moderate to severe(n=9,6,6,6) | 33 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day29:Severe (n=9,6,6,6) | 17 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day43:Almost clear(n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day43:Mild (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day43:Mild to moderate(n=9,6,6,6) | 33 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day43:Moderate (n=9,6,6,6) | 33 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day43:Severe (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day85:Almost clear(n=6,0,6,6) | 0 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day85:Mild to moderate(n=6,0,6,6) | 0 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day85:Moderate (n=6,0,6,6) | 50 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day85:Moderate to severe(n=6,0,6,6) | 17 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day85:Severe (n=6,0,6,6) | 33 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day121:Almost clear(n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day121:Mild (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day121:Mild to moderate(n=9,6,6,6) | 33 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day121:Moderate (n=9,6,6,6) | 17 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day121:Moderate to severe(n=9,6,6,6) | 17 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Baseline:Almost clear(n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day85:Almost clear(n=6,0,6,6) | 0 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day85:Mild (n=6,0,6,6) | 33 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day29:Mild (n=9,6,6,6) | 33 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Baseline:Severe (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day85:Mild to moderate(n=6,0,6,6) | 67 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day29:Almost clear(n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day121:Moderate (n=9,6,6,6) | 50 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day85:Moderate (n=6,0,6,6) | 0 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day15:Severe (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day121:Severe (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day85:Moderate to severe(n=6,0,6,6) | 0 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day15:Moderate to severe(n=9,6,6,6) | 17 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day121:Almost clear(n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day85:Severe (n=6,0,6,6) | 0 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day15:Moderate (n=9,6,6,6) | 17 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day15:Mild to moderate(n=9,6,6,6) | 33 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Baseline:Mild to moderate(n=9,6,6,6) | 33 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day15:Mild (n=9,6,6,6) | 33 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day121:Moderate to severe(n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day121:Mild (n=9,6,6,6) | 33 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Baseline:Moderate to sever(n=9,6,6,6) | 50 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Baseline:Moderate (n=9,6,6,6) | 17 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day15:Almost clear(n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day43:Mild to moderate(n=9,6,6,6) | 67 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day43:Mild (n=9,6,6,6) | 33 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day43:Almost clear(n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day121:Mild to moderate(n=9,6,6,6) | 17 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day43:Moderate (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day29:Severe (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day43:Moderate to severe(n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day29:Moderate to severe(n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day29:Moderate (n=9,6,6,6) | 17 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Baseline:Mild (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day43:Severe (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants in Each PGA Score Category | Day29:Mild to moderate(n=9,6,6,6) | 50 Percentage of participants |
Secondary
Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score
PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head, upper extremities, trunk and lower extremities with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged from 0=No symptoms, 1=slight, 2=moderate, 3=marked and 4=very marked) of erythema, induration and scaling in each of the 4 areas. PASI score ranges from 0 (no psoriasis) to 72 (worse psoriasis). Final PASI=(sum of severity score for each area) \* (% body area affected score \* area score). Baseline was considered as the latest pre-dose assessment with a non-missing value for Day -1.
Time frame: Baseline, Days 15, 29, 43, 85 and 121
Population: Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo for Healthy Volunteer Combined | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 50: Day 85 (n=6,0,6,6) | 17 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 50: Day 43 (n=9,6,6,6) | 11 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 75: Day 85 (n=6,0,6,6) | 0 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 75: Day 121 (n=9,6,6,6) | 0 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 75: Day 29 (n=9,6,6,6) | 0 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 75: Day 15 (n=9,6,6,6) | 0 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 75: Day 43 (n=9,6,6,6) | 0 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 50: Day 121 (n=9,6,6,6) | 11 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 50: Day 15 (n=9,6,6,6) | 0 Percentage of participants |
| Placebo for Healthy Volunteer Combined | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 50: Day 29 (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 50: Day 15 (n=9,6,6,6) | 17 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 50: Day 29 (n=9,6,6,6) | 33 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 50: Day 43 (n=9,6,6,6) | 33 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 50: Day 121 (n=9,6,6,6) | 17 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 75: Day 15 (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 75: Day 29 (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 75: Day 43 (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 75: Day 121 (n=9,6,6,6) | 17 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 75: Day 121 (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 75: Day 43 (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 75: Day 15 (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 50: Day 121 (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 75: Day 85 (n=6,0,6,6) | 0 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 50: Day 43 (n=9,6,6,6) | 17 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 75: Day 29 (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 50: Day 29 (n=9,6,6,6) | 17 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 50: Day 85 (n=6,0,6,6) | 0 Percentage of participants |
| GSK2831781 0.0015 mg/kg (ADA-ve) | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 50: Day 15 (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 50: Day 85 (n=6,0,6,6) | 17 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 75: Day 85 (n=6,0,6,6) | 0 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 50: Day 121 (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 75: Day 29 (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 75: Day 15 (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 75: Day 121 (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 75: Day 43 (n=9,6,6,6) | 0 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 50: Day 15 (n=9,6,6,6) | 17 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 50: Day 43 (n=9,6,6,6) | 33 Percentage of participants |
| GSK2831781 0.0075 mg/kg (ADA-ve) | Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score | PASI 50: Day 29 (n=9,6,6,6) | 17 Percentage of participants |
Secondary
Systemic Clearance of Parent Drug (CL) for GSK2831781 0.0003 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose
Population: PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.
Secondary
t1/2 for GSK2831781 0.0015 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Population: PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.
Secondary
t1/2 for GSK2831781 0.0075 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose
Population: PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.
Secondary
t1/2 for GSK2831781 0.04 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose
Population: PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.
Secondary
t1/2 for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose
Population: PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.
Secondary
t1/2 for GSK2831781 0.5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose
Population: PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.
Secondary
t1/2 for GSK2831781 1.5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose
Population: PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.
Secondary
t1/2 for GSK2831781 5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose
Population: PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.
Secondary
Terminal Elimination Rate (Lambda z) for GSK2831781 0.0003 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose
Population: PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.
Secondary
Terminal Phase Half-life (t1/2) for GSK2831781 0.0003 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose
Population: PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.
Secondary
Time of Last Quantifiable Concentration (Tlast) for GSK2831781 0.0003 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose
Population: PK population. Data was not collected because none of the participants had data evaluable for this measure.
Secondary
Time of Occurrence of Cmax (Tmax) for GSK2831781 0.0003 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose
Population: PK population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | Time of Occurrence of Cmax (Tmax) for GSK2831781 0.0003 mg/kg (ADA-ve) | NA Hours |
Secondary
Tlast for GSK2831781 0.0015 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Population: PK population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | Tlast for GSK2831781 0.0015 mg/kg (ADA-ve) | 1.950 Hours |
Secondary
Tlast for GSK2831781 0.0075 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose
Population: PK population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | Tlast for GSK2831781 0.0075 mg/kg (ADA-ve) | 18.005 Hours |
Secondary
Tlast for GSK2831781 0.04 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose
Population: PK population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | Tlast for GSK2831781 0.04 mg/kg (ADA-ve) | 72.065 Hours |
Secondary
Tlast for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose
Population: PK population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | Tlast for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve) | 238.750 Hours |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Tlast for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve) | 288.235 Hours |
Secondary
Tlast for GSK2831781 0.5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose
Population: PK population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | Tlast for GSK2831781 0.5 mg/kg | 468.655 Hours |
Secondary
Tlast for GSK2831781 1.5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose
Population: PK population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | Tlast for GSK2831781 1.5 mg/kg | 1343.930 Hours |
Secondary
Tlast for GSK2831781 5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose
Population: PK population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | Tlast for GSK2831781 5 mg/kg | 2016.050 Hours |
Secondary
Tmax for GSK2831781 0.0015 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Population: PK population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | Tmax for GSK2831781 0.0015 mg/kg (ADA-ve) | 1.950 Hours |
Secondary
Tmax for GSK2831781 0.0075 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose
Population: PK population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | Tmax for GSK2831781 0.0075 mg/kg (ADA-ve) | 1.950 Hours |
Secondary
Tmax for GSK2831781 0.04 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose
Population: PK population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | Tmax for GSK2831781 0.04 mg/kg (ADA-ve) | 4.025 Hours |
Secondary
Tmax for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose
Population: PK population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | Tmax for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve) | 1.980 Hours |
| GSK2831781 0.0003 mg/kg (ADA-ve) | Tmax for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve) | 4.990 Hours |
Secondary
Tmax for GSK2831781 0.5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose
Population: PK population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | Tmax for GSK2831781 0.5 mg/kg | 3.930 Hours |
Secondary
Tmax for GSK2831781 1.5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose
Population: PK population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | Tmax for GSK2831781 1.5 mg/kg | 1.990 Hours |
Secondary
Tmax for GSK2831781 5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose
Population: PK population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo for Healthy Volunteer Combined | Tmax for GSK2831781 5 mg/kg | 2.975 Hours |
Secondary
Volume of Distribution at Steady State (Vss) for GSK2831781 0.0003 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose
Population: PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.
Secondary
Vss for GSK2831781 0.0015 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Population: PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.
Secondary
Vss for GSK2831781 0.0075 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose
Population: PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.
Secondary
Vss for GSK2831781 0.04 mg/kg (ADA-ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose
Population: PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.
Secondary
Vss for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose
Population: PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.
Secondary
Vss for GSK2831781 0.5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose
Population: PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.
Secondary
Vss for GSK2831781 1.5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose
Population: PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.
Secondary
Vss for GSK2831781 5 mg/kg
Blood samples were collected at specified time points for GSK2831781 in plasma.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose
Population: PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.