Arthritis, Rheumatoid
Conditions
Brief summary
This FTIH study, intends to identify the doses of GSK3358699, which are well tolerated by the subjects whilst delivering a robust pharmacodynamic (PD) response. This study will evaluate the safety, tolerability, pharmacokinetic (PK) and PD profile of single (in both fed and fasted states) and multiple ascending doses of GSK3358699 in healthy male subjects within a pre-defined and controlled pharmacodynamic and pharmacokinetic range for each cohort. It also intends to understand the effect of GSK3358699 on systemic markers of inflammation following low dose in vivo lipopolysaccharide (LPS) or Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) challenge and local inflammation in cantharidin-induced blisters. The study has been carefully designed to explore the in vivo biology of the target and the potential for the study drug to become a transformative medicine for subjects in multiple immuno-inflammatory disease indications.
Detailed description
Subjects who are enrolled in the dose escalation treatment Periods of Part A may choose to only take part in the dose escalation treatment Periods 1-3, or may choose to also take part in the challenge Treatment Period (Period 4). If a subject chooses to participate in the dose escalation treatment Periods 1-3 only, or does not (at screening) meet the eligibility criteria specific to challenges (treatment Period 4), a new subject will be recruited for treatment Period 4 only and will be regarded as a replacement subject. The study will be conducted in three Parts. Total duration for participation will be approximately 19 weeks for subjects taking part in all three dose escalation treatment Periods and 23 weeks if a subject takes part in all four treatment Periods of Part A. For replacement subjects only taking part in the challenge treatment Period (Period 4), approximate study duration will be 10 weeks. Total duration for participation will be approximately 9 weeks for Part B and 12 weeks for Part C. The study will be conducted in up to 80 subjects.
Interventions
DRUGPlacebo
Placebo will be administered as a matching oral solution or matching capsule to study drug GSK3358699, during Part A and C once daily
DRUGGSK3358699
GSK3358699, will be administered from 1 mg to 45 mg as an oral solution (1 to 10 mg) or as a capsule (3 to 45 mg), in Part A, B and Part C once daily.
BIOLOGICALGM-CSF
The GM-CSF will be administered as an intravenous infusion to subjects as 60 microgram per meter\^2 in Part A (Day 1) and Part C (Day 14).This will be administered for 2 hours approximately, no later than 24 hours post -dose of the GSK3358699 or placebo in Part C
BIOLOGICALLPS
LPS will be administered as an intravenous injection to subjects not exceeding 0.75 nanogram per kilogram in Part A (Day 1) and Part C (Day 14). This will be administered no later than 24 hours post -dose of the GSK3358699 or placebo in Part C.
OTHERCantharidin
This will be applied as a topical application with 0.7% cantharidin liquid which will be diluted with acetone to 0.2%.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
This will be a double blind (sponsor open) study with respect to allocation of GSK3358699 or placebo to subjects. All site staff will be blinded with the exception of un-blinded pharmacists. Investigators will be un-blinded with respect to the LPS and GM-CSF allocation. The food effect part of the study (Part B) will be open-label
Intervention model description
Study will be conducted as Part A, B and C. Part A will consist of 2-interlocking cohorts, where each subject will receive maximum 2-single ascending oral doses of GSK3358699 and 1 dose of placebo, in Treatment Periods (TP) 1 to 3. In TP 4 subjects will receive GSK3358699, dose evaluated in TP (1 to 3) or placebo, with cantharidin induced blisters and either LPS or GM-CSF in vivo challenge. Part B will comprise of single cohort taking part in two-way cross over, with open label phase where each subject will receive single oral dose of GSK3358699 (based on Part A), under fed and fasted conditions in each TP. Part C will consist of 3 cohorts with multiple ascending doses, with every cohort having one repeat dose TP with 14 days of daily dosing of either GSK3358699 or placebo. Subjects on Day 14 will receive cantharidin induced blisters with either LPS or GM-CSF in vivo challenge. An optional, cohort 7 may be included for further dose evaluation of GSK3358699 or alternate dosing schedule.
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
- Subjects enrolled into the study, where they will be administered LPS or GM-CSF challenge, must be 18 to 55 years of age inclusive, at the time of signing the informed consent. Subjects enrolled into the study where they will not be administered LPS or GM-CSF challenge must be 18 to 65 years of age inclusive, at the time of signing the informed consent. - Subjects must be overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. - Body weight must be \> = 50 kilogram (kg) and body mass index (BMI) within the range 18.5-35.0 kg per square meter (kg/m\^2) (inclusive). - Male subjects agreeing to use contraceptive methods during the treatment Period and for at least 91 days, after the last dose of study treatment and refrain from donating sperm during this Period. - Capable of giving informed consent.
Exclusion criteria
- Current or chronic history of pancreatitis, diabetes mellitus or impaired glucose tolerance, gastrointestinal disease, liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), anaphylaxis, and /or anaphylactoid (resembling anaphylaxis) reactions \[Sampson et al 2006\], cardiac disease including clinically significant ventricular arrhythmias or long QT syndrome, renal disease where clinically significant (minor abnormalities may be permitted base on discussion between investigator and medical monitor), respiratory disease or conditions including but not limited to asthma, chronic obstructive pulmonary disease (COPD), and bronchiectasis and any current respiratory infection (childhood asthma is not an exclusion criterion), sensitivity or severe allergic responses to any of the challenge agents or cantharidin, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or GlaxoSmithKline (GSK) Medical Monitor, contraindicates their participation; frequent vasovagal syncope, surgery requiring general anaesthetic or significant trauma in 3 months leading to study enrolment, relevant skin conditions (e.g. recent history of eczema or recurrent eczema, keloid, skin allergies, psoriasis, atopic dermatitis, and vitiligo) which in the opinion of the investigator could pose safety issues or cause interference with study procedures, sepsis, coagulation disorders, peripheral edema, lymphangitis, lymphedema, pleural or pericardial effusion, hemorrhage (eg sub-arachnoid) or hemophilia or a related bleeding disorder. - History of malignancies e.g. recurrent basal cell carcinoma, hematological malignancy. - For subjects receiving cantharidin: Presence on either forearm of tattoos, naevi, hypertrophic scars, keloids, hyper- or hypo- pigmentation that may, in the opinion of the Investigator, interfere with study assessments. Subjects with very fair skin, very dark skin, excessive hair or any skin abnormalities that may, in the opinion of the Investigator, interfere with study assessments. - Family history of premature cardiovascular disease or long QT syndrome. - QT interval with Fridericia's correction (QTcF) \> 450 millisecond (msec), based on averaged QTcF values of triplicate ECGs obtained over a brief recording period. - Unable or unwilling to refrain from taking prescription or non-prescription drugs (including vitamins and dietary or herbal supplements) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before the start of study treatment until completion of the follow-up visit. Paracetamol, at a dose of \<= 2 grams per day was permitted for use anytime during the study. Other concomitant medications will be considered on case by case basis. - The subjects have participated in a clinical trial and received an investigational product within the following time period prior to the first dosing day in the study: 30 days; 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) or currently in a study of an investigational device. - Exposure to more than four new chemical entities within 12 months prior to the first dosing day. - Previous exposure to intravenous lipopolysaccharide (LPS) in a clinical research setting. - Alanine transaminase (ALT) \>1.5x upper limit of normal (ULN) at screening. - Bilirubin \>1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%) at screening. - Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. - A positive pre-study drug/alcohol screen at screening. - A positive test for human immunodeficiency virus (HIV) antibody at screening. - Persistent clinically significant abnormal C-reactive protein (CRP) levels at screening - Persistent clinically significant abnormal white cell count (WCC) levels at screening (if clinically significant abnormality is detected, WCC can be retested as clinically indicated) - Platelets \< 150 x 10\^9 per liter (L) at screening. - Fasted Triglycerides \>3.4 millimole per liter (mmol/L) at screening. - Fasted Total cholesterol \>7.7 mmol/L at screening. - Random glucose \> = 11.1 mmol/L at screening. - Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 3 months prior to screening. - History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of \>14 units. One unit is equivalent to 8 gram of alcohol: a half-pint (approximately 240 milliliter \[mL\]) of beer, 1 glass (125 mL) of wine or 1 (25 mL). - Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period. - Unable to comply with precautions to minimize phototoxicity risk.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Day 193 | An adverse event (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 medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, important medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed before. Safety Population consisted of all randomized participants who took at least 1 dose of study treatment. |
| Part B: Number of Participants With AEs and SAEs | Up to Day 30 | 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 medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, important medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed before. |
| Part C: Number of Participants With AEs and SAEs | Up to Day 49 | 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 medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, important medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed before. |
| Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Up to Day 193 | Blood samples were collected for analysis of clinical chemistry parameters. PCI ranges were \<30 grams per liter (g/L) (albumin), \<2 or \>2.75 millimoles/L (mmol/L) (calcium), \>1.3\* upper limit of normal (ULN) mmol/L (creatinine), \<3 or \>9 mmol/L (glucose), \<3 or \>5.5 mmol/L (potassium), and \<130 or \>150 mmol/L (sodium). Participants were counted in worst case category that their value changes to (low, within range or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in To within Range or No Change (NC) category. Participants were counted twice if participant had values that changed To Low and To High, so the percentages may not add to 100%. |
| Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to Day 193 | Clinical chemistry parameters assessed were alanine aminotransferase(ALT)(\<10 or \>50 international units per liter\[IU/L\]),alkaline phosphatase(ALP)(\<40 or \>129 IU/L),aspartate aminotransferase(AST)(\<0 or \>37 IU/L),cholesterol(\<2.3 or \>4.9 mmol/L),direct bilirubin(DB)(\<0 or \>5 micromoles\[mcmol\]/L),high density lipoprotein (DL)(\<0.9 or \>1.5 mmol/L),C-reactive protein(CRP)(\<0.0 or \>5.0mg/liter),low DL(\<0 or \>3.0 mmol/L), total bilirubin (\<0 or \>20 mcmol/L),total protein(\<63 or \>83 grams/L),triglycerides(\<0 or \>2.3 mmol/L) and blood urea nitrogen(BUN)(\<4.76 or \>23.24 mg/deciliter).Participants were counted in worst case category that their value changes to (low, normal or high), unless there is NC in their category.Participants whose laboratory value category was unchanged(e.g.,High to High) or whose value became normal, are recorded in To Normal or NC category.Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%. |
| Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Up to Day 30 | Blood samples were planned to be collected to analyze the chemistry parameters. |
| Part B: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to Day 30 | Blood samples were planned to be collected to analyze the chemistry parameters. |
| Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Up to Day 28 | Blood samples were collected for analysis of chemistry parameters. PCI ranges were \<30 g/L (albumin), \<2 or \>2.75 mmol/L (calcium), \>1.3\* ULN mmol/L (creatinine), \<3 or \>9 mmol/L (glucose), \<3 or \>5.5 mmol/L (potassium), and \<130 or \>150 mmol/L (sodium). Participants were counted in worst case category that their value changes to (low, within range or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in To within Range or No Change category. Participants were counted twice if participant had values that changed To Low and To High, so the percentages may not add to 100%. |
| Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to Day 28 | Clinical chemistry parameters assessed were ALT (\<10 or \>50 IU/L), ALP (\<40 or \>129 IU/L), AST (\<0 or \>37 IU/L), cholesterol (\<2.3 or \>4.9 mmol/L), DB (\<0 or \>5 mcmol/L), high DL (\<0.9 or \>1.5 mmol/L), CRP (\<0.0 or \>5.0 mg/liter), low DL (\<0 or \>3.0 mmol/L), total bilirubin (\<0 or \>20 mcmol/L), total protein (\<63 or \>83 grams/L), triglycerides (\<0 or \>2.3 mmol/L) and BUN (\<4.76 or \>23.24 mg/deciliter). Participants were counted in worst case category that their value changes to (low, normal or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g., High to High) or whose value became normal, are recorded in To Normal or NC category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%. |
| Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Up to Day 193 | Blood samples collected for analysis of hematology parameters. PCI ranges were \>0.54 proportion of red blood cells in blood (hematocrit), \>180 grams/liter (hemoglobin), \<0.8 \*10\^9 cells/L (lymphocyte count), \<1.5 \*10\^9 cells/L (total absolute neutrophil count \[ANC\]), \<100 or \>550 \*10\^9 cells/L (platelet count), and \<3 or \>20\*10\^9 cells/L (white blood cell \[WBC\] count). Participants were counted in worst case category that their value changes to (low, within range or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in To within Range or No Change category. Participants were counted twice if the participant had values that changed To Low and To High, so the percentages may not add to 100%. |
| Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to Day 193 | Hematology parameters assessed were activated partial thromboplastin time (APTT) (\<25 or \>37 seconds), basophil count (\<0.0 or \>0.1\*10\^9 cells/L), eosinophil count (\<0.0 or \>0.4\*10\^9 cells/L), fibrinogen (\<1.5 or \>4.0 g/L), mean corpuscle hemoglobin (MCH) (\<26.0 or \>33.5 picogram), mean corpuscle volume (MCV) (\<80 or \>99 femtoliter), monocyte count (\<0.2 or \>1.0\*10\^9 cells/L), prothrombin time (PT) (\<10 or \>12 seconds), red blood cell (RBC) count (\<4.4 or \>5.8\*10\^12 cells/L) and reticulocyte count (\<0.38 or \>2.64 percentage of reticulocytes). Participants were counted in worst case category that their value changes to (low, normal or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g., High to High) or whose value became normal, are recorded in To Normal or NC category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%. |
| Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Up to Day 30 | Blood samples were planned to be collected to analyze hematology parameters. |
| Part B: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to Day 30 | Blood samples were planned to be collected to analyze hematology parameters. |
| Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Up to Day 28 | Blood samples were collected for analysis of hematology parameters. PCI ranges were \>0.54 proportion of red blood cells in blood (hematocrit), \>180 grams/liter (hemoglobin), \<0.8\*10\^9 cells/L (lymphocyte count), \<1.5\*10\^9 cells/L (total ANC), \<100 or \>550\*10\^9 cells/L (platelet count), and \<3 or \>20\*10\^9 cells/L (WBC count). Participants were counted in worst case category that their value changes to (low, within range or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in To within Range or No Change category. Participants were counted twice if the participant had values that changed To Low and To High, so the percentages may not add to 100%. |
| Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to Day 28 | Hematology parameters assessed were APTT (\<25 or \>37 seconds), basophil count (\<0.0 or \>0.1\*10\^9 cells/L), eosinophil count (\<0.0 or \>0.4\*10\^9 cells/L), fibrinogen (\<1.5 or \>4.0 g/L), MCH (\<26.0 or \>33.5 picogram), MCV (\<80 or \>99 femtoliter), monocyte count (\<0.2 or \>1.0\*10\^9 cells/L), PT (\<10 or \>12 seconds), RBC count (\<4.4 or \>5.8\*10\^12 cells/L) and reticulocyte count (\<0.38 or \>2.64 percentage of reticulocytes). Participants were counted in worst case category that their value changes to (low, normal or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g., High to High) or whose value became normal, are recorded in To Normal or NC category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%. |
| Part A: Number of Participants With Abnormal Urinalysis Parameters | Up to Day 193 | Urine samples were collected from participants for analyzing the following urine parameters: potential of hydrogen (pH) and glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocytes levels by dipstick. Urine samples showing any abnormality were sent for microscopic examination to detect the presence of RBC, WBC, cellular casts, granular casts, hyaline casts, and were counted as cells per high-power field (cells/HPF). Number of participants with abnormal urinalysis result by microscopic examination have been presented. |
| Part B: Number of Participants With Abnormal Urinalysis Parameters | Up to Day 30 | Urine samples were planned to be collected to analyze urine parameters. |
| Part C: Number of Participants With Abnormal Urinalysis Parameters | Up to Day 28 | Urine samples were collected from participants for analyzing the following urine parameters: pH and glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocytes levels by dipstick. Urine samples showing any abnormality were sent for microscopic examination to detect the presence of RBC, WBC, cellular casts, granular casts, hyaline casts, and were counted as cells/HPF. Number of participants with abnormal urinalysis result by microscopic examination have been presented. |
| Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Up to Day 193 | Vital signs included systolic blood pressure(SBP), diastolic blood pressure(DBP), heart rate, respiratory rate and body temperature and were measured in a semi-supine position after 5 minutes rest. PCI ranges were, SBP (millimeters of mercury \[mmHg\]): \<85 (low) or \>160 (high), DBP (mmHg): \<45 (low) or \>100 (high), heart rate (beats per minute): \<40 (low) or \>110 (high), respiration rate (breaths per minute): \<11(low) or \>20(high) and body temperature (degrees Celsius) \<35.5 (low) or \>38.0 (high). Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants whose vital signs value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the To within Range or No Change category. Participants were counted twice if the participant had values that changed To Low and To High, so the percentages may not add to 100%. |
| Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Up to Day 30 | Vital signs were planned to be measured in a semi-supine position after 5 minutes of rest. |
| Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Up to Day 49 | Vital signs included SBP, DBP, heart rate, respiratory rate and body temperature and were measured in a semi-supine position after 5 minutes rest. PCI ranges were, SBP (mmHg): \<85 (low) or \>160 (high), DBP (mmHg): \<45 (low) or \>100 (high), heart rate (beats per minute): \<40 (low) or \>110 (high), respiration rate (breaths per minute): \<11 (low) or \>20 (high) and body temperature (degrees Celsius) \<35.5 (low) or \>38.0 (high). Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants whose vital signs value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the To within Range or No Change category. Participants were counted twice if the participant had values that changed To Low and To High, so the percentages may not add to 100%. |
| Part A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Up to Day 193 | Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF) intervals. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline abnormal ECG findings have been presented. |
| Part B: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings | Up to Day 30 | Twelve lead ECGs were planned to be performed to measure PR interval, QRS duration, QT interval and QTcF. |
| Part C: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings | Up to Day 28 | Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QTcF intervals. Abnormal findings were categorized as clinically significant and not clinically significant. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline abnormal ECG findings have been presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part C: Plasma Concentrations of GSK3206944 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Days 4, 8 and 12: Pre-dose; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699. |
| Part A: AUC(0-t) of GSK3206944 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699. |
| Part B: AUC(0-t) of GSK3206944 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period | Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3206944. GSK3206944 is a metabolite of GSK3358699. |
| Part C: AUC(0-t) of GSK3206944 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699. |
| Part B: AUC(0-infinity) of GSK3206944 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period | Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3206944. GSK3206944 is a metabolite of GSK3358699. |
| Part C: AUC(0-infinity) of GSK3206944 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699. |
| Part A: AUC(0-24) of GSK3206944 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours post-dose in each treatment period | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699. |
| Part B: AUC(0-24) of GSK3206944 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours post-dose in each treatment period | Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3206944. GSK3206944 is a metabolite of GSK3358699. |
| Part C: AUC(0-24) of GSK3206944 | Days 1 and 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699. |
| Part A: Cmax of GSK3206944 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699. |
| Part B: Cmax of GSK3206944 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period | Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3206944. GSK3206944 is a metabolite of GSK3358699. |
| Part C: Cmax of GSK3206944 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699. |
| Part A: Tmax of GSK3206944 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699. |
| Part B: Tmax of GSK3206944 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period | Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3206944. GSK3206944 is a metabolite of GSK3358699. |
| Part C: Tmax of GSK3206944 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699. |
| Part A: t1/2 of GSK3206944 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699. |
| Part B: t1/2 of GSK3206944 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period | Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3206944. GSK3206944 is a metabolite of GSK3358699. |
| Part C: t1/2 of GSK3206944 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699. |
| Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 1, 4, 8, 24 and 48 hours post-dose in each treatment period | Blood samples were collected into sodium heparin tubes for the isolation of monocytes and for measurement of GSK3206944 concentrations in monocytes. GSK3206944 is a metabolite of GSK3358699. |
| Part B: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 1, 4, 8, 24 and 48 hours post-dose in each treatment period | Blood samples were planned to be collected into sodium heparin tubes for the isolation of monocytes and for measurement of GSK3206944 concentrations in monocytes. GSK3206944 is a metabolite of GSK3358699. |
| Part C: Monocyte Intracellular Concentration of GSK3206944 | Days 1 and 13: 1, 4 and 8 hour; Days 4, 8 and 12: Pre-dose; Day 14: 1, 4, 8, 24 and 48 hours post-dose | Blood samples were collected into sodium heparin tubes for the isolation of monocytes and for measurement of GSK3206944 concentrations in monocytes. GSK3206944 is a metabolite of GSK3358699. |
| Part A: Plasma Concentrations of GSK3358699 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. Pharmacokinetic (PK) parameters were calculated using standard non-compartmental analysis. PK Population consisted of all participants in the Safety Population who received an active dose and for whom a PK sample was obtained and analyzed. |
| Part B: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | Day 1: 1, 4, 8, 12, 24 and 48 hours | Whole blood samples were planned to be collected in TruCulture tubes, containing LPS and incubated for 24 hours, post which the inflammatory mediators (MCP-1, IL6 and TNF alpha) were planned to be analyzed. |
| Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | Day 1: 1, 4 and 8 hours; Days 2, 4, 8 and 12: Pre-dose; Day 13: Pre-dose, 1, 4 and 8 hours; Day 14: Pre-dose, Pre-LPS challenge, 1, 4, 8, 24 and 48 hours | Whole blood samples of 1 mL were collected in TruCulture tubes, containing LPS and incubated for 24 hours, post which the inflammatory mediators (MCP-1, IL-6 and TNF alpha) were analyzed. |
| Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: 1, 4, 8, 12, 24 and 48 hours | Whole blood samples of 1 milliliter (mL) were collected in TruCulture tubes, containing LPS and incubated for 24 hours, post which the inflammatory mediators (MCP-1, IL-6 and TNF alpha) were analyzed. |
| Part B: Plasma Concentrations of GSK3358699 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period | Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3358699. |
| Part C: Plasma Concentrations of GSK3358699 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Days 4, 8 and 12: Pre-dose; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis. |
| Part A: Area Under the Plasma Concentration Curve From Time Zero to Last Time of Quantifiable Concentration (AUC[0-t]) of GSK3358699 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis. |
| Part B: AUC(0-t) of GSK3358699 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period | Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3358699. |
| Part C: AUC(0-t) of GSK3358699 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis. |
| Part A: Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-infinity]) of GSK3358699 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis. |
| Part B: AUC(0-infinity) of GSK3358699 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period | Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3358699. |
| Part C: AUC(0-infinity) of GSK3358699 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis. |
| Part A: Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) of GSK3358699 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours post-dose in each treatment period | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis. |
| Part B: AUC(0-24) of GSK3358699 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours post-dose in each treatment period | Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3358699. |
| Part C: AUC(0-24) of GSK3358699 | Days 1 and 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis. |
| Part A: Maximum Plasma Concentration (Cmax) of GSK3358699 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis. |
| Part B: Cmax of GSK3358699 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period | Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3358699. |
| Part A: AUC(0-infinity) of GSK3206944 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699. |
| Part C: Cmax of GSK3358699 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis. |
| Part A: Time to Cmax (Tmax) of GSK3358699 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis. |
| Part B: Tmax of GSK3358699 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period | Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3358699. |
| Part C: Tmax of GSK3358699 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis. |
| Part A: Apparent Terminal Phase Half-life (t1/2) of GSK3358699 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis. |
| Part B: t1/2 of GSK3358699 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period | Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3358699. |
| Part C: t1/2 of GSK3358699 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis. |
| Part A: Plasma Concentrations of GSK3206944 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699. |
| Part B: Plasma Concentrations of GSK3206944 | Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period | Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3206944. GSK3206944 is a metabolite of GSK3358699. |
Countries
United Kingdom
Participant flow
Recruitment details
This was a randomized, double-blind, placebo-controlled, 3-part study. Part A was single ascending dose crossover with 2 interlocking cohorts(1 and 2);Part B was planned to be a single dose, open-label, 2-way crossover in fed, fasted conditions(Cohort3);Part C was repeat dose design in sequential cohorts(4,5) and cohorts 6 to 8 were planned.
Pre-assignment details
A total 48 participants were enrolled in this study. Part B and Part C (Cohorts 6 to 8) were not initiated as the study was terminated early due to strategic reasons following emergence of new data. Hence, no participants were enrolled in Part B and Part C (Cohorts 6 to 8).
Participants by arm
| Arm | Count |
|---|---|
| Part A: Cohort 1- Sequence PCEP Participants in Part A Cohort 1 were planned to receive a single dose (SD) of placebo (Treatment P) on Day 1 in treatment Period 1. Participants were received a SD of GSK3358699 10 milligram (mg) (Treatment C) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 40 mg (Treatment E) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by intravenous (IV) administration of in vivo lipopolysaccharide (LPS) challenge at a dose of 0.75 nanograms per kilogram (ng/kg) and further treated with 0.2 percent (%) cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period. | 1 |
| Part A: Cohort 1- Sequence PCER Participants in Part A Cohort 1 received a SD of placebo (Treatment P) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 10 mg (Treatment C) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 40 mg (Treatment E) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period. | 2 |
| Part A: Cohort 1- Sequence APEP Participants in Part A Cohort 1 received a SD of GSK3358699 1 mg (Treatment A) on Day 1 in treatment Period 1; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 40 mg (Treatment E) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period. | 2 |
| Part A: Cohort 1- Sequence APER Participants in Part A Cohort 1 received a SD of GSK3358699 1 mg (Treatment A) on Day 1 in treatment Period 1; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 40 mg (Treatment E) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period. | 2 |
| Part A: Cohort 1- Sequence ACPP Participants in Part A Cohort 1 received a SD of GSK3358699 1 mg (Treatment A) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 10 mg (Treatment C) on Day 1 in treatment Period 2; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period. | 2 |
| Part A: Cohort 1- Sequence ACPR Participants in Part A Cohort 1 received a SD of GSK3358699 1 mg (Treatment A) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 10 mg (Treatment C) on Day 1 in treatment Period 2; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period. | 4 |
| Part A: Cohort 2- Sequence PDFP Participants in Part A Cohort 2 received a SD of placebo (Treatment P) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 20 mg (Treatment D) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 30 mg (Treatment F) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo administration of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) at a dose of 60 micrograms per meter square (mcg/m\^2) and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period. | 1 |
| Part A: Cohort 2- Sequence PDFR Participants in Part A Cohort 2 received a SD of placebo (Treatment P) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 20 mg (Treatment D) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 30 mg (Treatment F) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period. | 3 |
| Part A: Cohort 2- Sequence BPFP Participants in Part A Cohort 2 received a SD of GSK3358699 3 mg (Treatment B) on Day 1 in treatment Period 1; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 30 mg (Treatment F) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period. | 1 |
| Part A: Cohort 2- Sequence BPFR Participants in Part A Cohort 2 were planned to receive a SD of GSK3358699 3 mg (Treatment B) on Day 1 in treatment Period 1.Participants were received a SD of placebo (Treatment P) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 30 mg (Treatment F) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period. | 2 |
| Part A: Cohort 2- Sequence BDPP Participants in Part A Cohort 2 received a SD of GSK3358699 3 mg (Treatment B) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 20 mg (Treatment D) on Day 1 in treatment Period 2; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period. | 1 |
| Part A: Cohort 2- Sequence BDPR Participants in Part A Cohort 2 received a SD of GSK3358699 3 mg (Treatment B) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 20 mg (Treatment D) on Day 1 in treatment Period 2; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period. | 2 |
| Part B: Cohort 3- GSK3358699 Fed + GSK3358699 Fasted Participants in Part B Cohort 3 were planned to receive a SD of GSK3358699 under fed conditions on Day 1 in treatment Period 1; followed by a SD of GSK3358699 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 14 days between each treatment period. | 0 |
| Part B: Cohort 3- GSK3358699 Fasted + GSK3358699 Fed Participants in Part B Cohort 3 were planned to receive a SD of GSK3358699 under fasted conditions on Day 1 in treatment Period 1; followed by a SD of GSK3358699 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 14 days between each treatment period. | 0 |
| Part C: Cohort 4 and 5- Placebo RD Participants received once daily RD of placebo on Days 1 to 14. In Cohort 4, on Day 14, participants were administered an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo at a dose of 60 mcg/m\^2. The administration of LPS or GM-CSF was followed by blister induction on forearm (0.2% cantharidin). | 11 |
| Part C: Cohort 4 and 5- GSK3358699 10 mg RD Participants received once daily repeat dose of GSK3358699 10 mg on Days 1 to 14. In Cohort 4, on Day 14, participants were administered an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo at a dose of 60 mcg/m\^2. The administration of LPS or GM-CSF was followed by blister induction on forearm (0.2% cantharidin). | 14 |
| Part C: Cohort 6- GSK3358699 or Placebo RD Participants in Part C Cohort 6 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14. | 0 |
| Part C: Cohort 7- GSK3358699 or Placebo RD Participants in Part C Cohort 7 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14. | 0 |
| Part C: Cohort 8- GSK3358699 or Placebo RD Participants in Part C Cohort 8 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14. On Day 14, participants were planned to receive an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo as 60 mcg/m\^2. The administration of LPS or GM-CSF was planned to be followed by blister induction on forearm (0.2% cantharidin). | 0 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A: Cohort 1-Period 1 (Day1) | Protocol defined stopping criteria | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A: Cohort 1-Period 2 (Day1) | Adverse Event | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A: Cohort 1-Period 2 (Day1) | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A: Cohort 2-Period 4 (Day1) | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A: Cohort 2-Period 4 (Day1) | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part C: Cohorts 4 to 8 (Days 1 to 14) | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 3 | 0 | 0 | 0 |
| Part C: Cohorts 4 to 8 (Days 1 to 14) | Study Closed/Terminated | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 9 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Part A: Cohort 1- Sequence PCEP | Part A: Cohort 1- Sequence PCER | Part A: Cohort 1- Sequence APEP | Part A: Cohort 1- Sequence APER | Part A: Cohort 1- Sequence ACPP | Part A: Cohort 1- Sequence ACPR | Part A: Cohort 2- Sequence PDFP | Part A: Cohort 2- Sequence PDFR | Part A: Cohort 2- Sequence BPFP | Part A: Cohort 2- Sequence BPFR | Part A: Cohort 2- Sequence BDPP | Part A: Cohort 2- Sequence BDPR | Part C: Cohort 4 and 5- Placebo RD | Part C: Cohort 4 and 5- GSK3358699 10 mg RD |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized >18 and <65 years | 47 Participants | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 4 Participants | 1 Participants | 3 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 11 Participants | 14 Participants |
| Age, Customized <=18 years | 1 Participants | 0 Participants | 1 Participants | 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, Customized >=65 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 | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Multiple | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White-White/Caucasian/European Heritage | 45 Participants | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 1 Participants | 3 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 10 Participants | 14 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 48 Participants | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 4 Participants | 1 Participants | 3 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 11 Participants | 14 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 | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 5 | 0 / 3 | 0 / 6 | 0 / 6 | 0 / 12 | 0 / 6 | 0 / 6 | 0 / 0 | 0 / 0 | 0 / 11 | 0 / 14 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 4 / 23 | 2 / 5 | 3 / 3 | 2 / 6 | 3 / 6 | 8 / 12 | 4 / 6 | 3 / 6 | 0 / 0 | 0 / 0 | 7 / 11 | 7 / 14 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 23 | 0 / 5 | 0 / 3 | 0 / 6 | 0 / 6 | 0 / 12 | 0 / 6 | 0 / 6 | 0 / 0 | 0 / 0 | 0 / 11 | 1 / 14 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Part A: Number of Participants With Abnormal Urinalysis Parameters
Urine samples were collected from participants for analyzing the following urine parameters: potential of hydrogen (pH) and glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocytes levels by dipstick. Urine samples showing any abnormality were sent for microscopic examination to detect the presence of RBC, WBC, cellular casts, granular casts, hyaline casts, and were counted as cells per high-power field (cells/HPF). Number of participants with abnormal urinalysis result by microscopic examination have been presented.
Time frame: Up to Day 193
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | WBC | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | Cellular casts | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | Granular casts | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | Hyaline casts | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | RBC | 2 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | Granular casts | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | WBC | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | Cellular casts | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | Hyaline casts | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | RBC | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | RBC | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | Hyaline casts | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | WBC | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | Granular casts | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | Cellular casts | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | WBC | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | RBC | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | Hyaline casts | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | Granular casts | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | Cellular casts | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | Granular casts | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | RBC | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | Cellular casts | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | Hyaline casts | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | WBC | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | Granular casts | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | RBC | 1 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | WBC | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | Cellular casts | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | Hyaline casts | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | Cellular casts | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | RBC | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | WBC | 1 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | Hyaline casts | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | Granular casts | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | Cellular casts | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | Granular casts | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | WBC | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | RBC | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Abnormal Urinalysis Parameters | Hyaline casts | 0 Participants |
Primary
Part A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An adverse event (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 medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, important medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed before. Safety Population consisted of all randomized participants who took at least 1 dose of study treatment.
Time frame: Up to Day 193
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo SD | Part A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 8 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 2 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 2 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 3 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 8 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 4 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 3 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
Primary
Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Blood samples were collected for analysis of clinical chemistry parameters. PCI ranges were \<30 grams per liter (g/L) (albumin), \<2 or \>2.75 millimoles/L (mmol/L) (calcium), \>1.3\* upper limit of normal (ULN) mmol/L (creatinine), \<3 or \>9 mmol/L (glucose), \<3 or \>5.5 mmol/L (potassium), and \<130 or \>150 mmol/L (sodium). Participants were counted in worst case category that their value changes to (low, within range or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in To within Range or No Change (NC) category. Participants were counted twice if participant had values that changed To Low and To High, so the percentages may not add to 100%.
Time frame: Up to Day 193
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To within Range or No Change | 23 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To Low | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To within Range or No Change | 23 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To Low | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To High | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To High | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium: To within Range or No Change | 23 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To within Range or No Change | 22 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To Low | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To High | 1 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium: To Low | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To High | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium: To High | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To within Range or No Change | 23 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To Low | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To Low | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To High | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To within Range or No Change | 23 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To within Range or No Change | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To within Range or No Change | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To within Range or No Change | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To within Range or No Change | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To within Range or No Change | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium: To within Range or No Change | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To High | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To Low | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To High | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To High | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To within Range or No Change | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium: To within Range or No Change | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To within Range or No Change | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To Low | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To Low | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To High | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To within Range or No Change | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To High | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To High | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To Low | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To within Range or No Change | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium: To Low | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium: To High | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To within Range or No Change | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To Low | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To Low | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To High | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To High | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To High | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium: To Low | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium: To High | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To Low | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To High | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To Low | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To Low | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To High | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To Low | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium: To High | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To High | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To Low | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To High | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To Low | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To Low | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium: To Low | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To High | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To Low | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To High | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To High | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To Low | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To High | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To High | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To within Range or No Change | 12 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To High | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To within Range or No Change | 12 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To Low | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To High | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium: To within Range or No Change | 12 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To Low | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To High | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To Low | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To Low | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To within Range or No Change | 12 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium: To High | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To within Range or No Change | 12 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium: To Low | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To within Range or No Change | 12 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To Low | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To High | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To Low | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To High | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium: To Low | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium: To High | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To Low | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To High | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To Low | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To High | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To Low | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To High | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To Low | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To Low | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To High | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To Low | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To High | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To High | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To Low | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium: To High | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To Low | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium: To Low | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To High | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To Low | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To High | 0 Participants |
Primary
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Clinical chemistry parameters assessed were alanine aminotransferase(ALT)(\<10 or \>50 international units per liter\[IU/L\]),alkaline phosphatase(ALP)(\<40 or \>129 IU/L),aspartate aminotransferase(AST)(\<0 or \>37 IU/L),cholesterol(\<2.3 or \>4.9 mmol/L),direct bilirubin(DB)(\<0 or \>5 micromoles\[mcmol\]/L),high density lipoprotein (DL)(\<0.9 or \>1.5 mmol/L),C-reactive protein(CRP)(\<0.0 or \>5.0mg/liter),low DL(\<0 or \>3.0 mmol/L), total bilirubin (\<0 or \>20 mcmol/L),total protein(\<63 or \>83 grams/L),triglycerides(\<0 or \>2.3 mmol/L) and blood urea nitrogen(BUN)(\<4.76 or \>23.24 mg/deciliter).Participants were counted in worst case category that their value changes to (low, normal or high), unless there is NC in their category.Participants whose laboratory value category was unchanged(e.g.,High to High) or whose value became normal, are recorded in To Normal or NC category.Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%.
Time frame: Up to Day 193
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 (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides:To Normal or NC,n=23,5,3,6,6,12,6,6 | 17 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB:To Normal or NC,n=23,5,3,6,6,12,6,6 | 22 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To High,n=23,5,3,6,6,12,6,6 | 2 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein:To Normal or NC,n=23,5,3,6,6,12,6,6 | 19 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To High,n=23,5,3,6,6,12,6,6 | 1 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To Normal or NC,n=23,5,3,6,6,12,6,6 | 22 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To High,n=23,5,3,6,6,12,6,6 | 1 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To Low,n=23,5,3,6,4,12,6,6 | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein: To Low,n=23,5,3,6,6,12,6,6 | 4 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL: To Low,n=23,5,3,6,6,12,6,6 | 1 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To High,n=23,5,3,6,6,12,6,6 | 1 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To Normal or NC,n=23,5,3,6,6,12,6,6 | 22 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To Normal or NC,n=23,5,3,6,4,12,6,6 | 18 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin: To High,n=23,5,3,6,6,12,6,6 | 1 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB: To High,n=23,5,3,6,6,12,6,6 | 1 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides: To High,n=23,5,3,6,6,12,6,6 | 6 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin:ToNormal or NC,n=23,5,3,6,6,12,6,6 | 22 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To High,n=23,5,3,6,4,12,6,6 | 5 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To Normal or NC,n=23,5,3,6,6,12,6,6 | 21 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To Normal or NC,n=23,5,3,6,6,12,6,6 | 23 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL:To Normal or NC,n=23,5,3,6,6,12,6,6 | 22 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To Normal or NC,n=23,5,3,6,6,12,6,6 | 23 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To Normal or NC,n=23,5,3,6,6,12,6,6 | 22 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To Normal or NC,n=23,5,3,6,6,12,6,6 | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To Normal or NC,n=23,5,3,6,6,12,6,6 | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein:To Normal or NC,n=23,5,3,6,6,12,6,6 | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides: To High,n=23,5,3,6,6,12,6,6 | 2 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides:To Normal or NC,n=23,5,3,6,6,12,6,6 | 3 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL: To Low,n=23,5,3,6,6,12,6,6 | 2 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin:ToNormal or NC,n=23,5,3,6,6,12,6,6 | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL:To Normal or NC,n=23,5,3,6,6,12,6,6 | 2 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB:To Normal or NC,n=23,5,3,6,6,12,6,6 | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL: To High,n=23,5,3,6,6,12,6,6 | 1 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To High,n=23,5,3,6,6,12,6,6 | 1 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To Normal or NC,n=23,5,3,6,6,12,6,6 | 4 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To Low,n=23,5,3,6,4,12,6,6 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To Normal or NC,n=23,5,3,6,6,12,6,6 | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To Normal or NC,n=23,5,3,6,6,12,6,6 | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To Normal or NC,n=23,5,3,6,4,12,6,6 | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To High,n=23,5,3,6,4,12,6,6 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To Normal or NC,n=23,5,3,6,6,12,6,6 | 4 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To Low,n=23,5,3,6,6,12,6,6 | 1 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL:To Normal or NC,n=23,5,3,6,6,12,6,6 | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB: To High,n=23,5,3,6,6,12,6,6 | 1 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein:To Normal or NC,n=23,5,3,6,6,12,6,6 | 2 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides: To High,n=23,5,3,6,6,12,6,6 | 1 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To Low,n=23,5,3,6,4,12,6,6 | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To Normal or NC,n=23,5,3,6,4,12,6,6 | 2 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To High,n=23,5,3,6,4,12,6,6 | 1 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To Normal or NC,n=23,5,3,6,6,12,6,6 | 2 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To High,n=23,5,3,6,6,12,6,6 | 1 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To Normal or NC,n=23,5,3,6,6,12,6,6 | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To Normal or NC,n=23,5,3,6,6,12,6,6 | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To Normal or NC,n=23,5,3,6,6,12,6,6 | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To Normal or NC,n=23,5,3,6,6,12,6,6 | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB:To Normal or NC,n=23,5,3,6,6,12,6,6 | 2 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin:ToNormal or NC,n=23,5,3,6,6,12,6,6 | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein: To Low,n=23,5,3,6,6,12,6,6 | 1 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides:To Normal or NC,n=23,5,3,6,6,12,6,6 | 2 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To Normal or NC,n=23,5,3,6,6,12,6,6 | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To Normal or NC,n=23,5,3,6,6,12,6,6 | 5 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To Normal or NC,n=23,5,3,6,6,12,6,6 | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To Low,n=23,5,3,6,4,12,6,6 | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To Normal or NC,n=23,5,3,6,6,12,6,6 | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides: To High,n=23,5,3,6,6,12,6,6 | 2 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To High,n=23,5,3,6,6,12,6,6 | 2 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein:To Normal or NC,n=23,5,3,6,6,12,6,6 | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides:To Normal or NC,n=23,5,3,6,6,12,6,6 | 4 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To High,n=23,5,3,6,4,12,6,6 | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To Normal or NC,n=23,5,3,6,6,12,6,6 | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To Normal or NC,n=23,5,3,6,6,12,6,6 | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL: To Low,n=23,5,3,6,6,12,6,6 | 1 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin:ToNormal or NC,n=23,5,3,6,6,12,6,6 | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB:To Normal or NC,n=23,5,3,6,6,12,6,6 | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL:To Normal or NC,n=23,5,3,6,6,12,6,6 | 5 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To Normal or NC,n=23,5,3,6,4,12,6,6 | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To High,n=23,5,3,6,6,12,6,6 | 1 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To Normal or NC,n=23,5,3,6,6,12,6,6 | 4 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To High,n=23,5,3,6,4,12,6,6 | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To Normal or NC,n=23,5,3,6,6,12,6,6 | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To Normal or NC,n=23,5,3,6,6,12,6,6 | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To Low,n=23,5,3,6,4,12,6,6 | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To Normal or NC,n=23,5,3,6,6,12,6,6 | 5 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To Normal or NC,n=23,5,3,6,6,12,6,6 | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To High,n=23,5,3,6,6,12,6,6 | 1 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB:To Normal or NC,n=23,5,3,6,6,12,6,6 | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To Normal or NC,n=23,5,3,6,4,12,6,6 | 4 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin:ToNormal or NC,n=23,5,3,6,6,12,6,6 | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL:To Normal or NC,n=23,5,3,6,6,12,6,6 | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein: To Low,n=23,5,3,6,6,12,6,6 | 2 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides: To High,n=23,5,3,6,6,12,6,6 | 2 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides:To Normal or NC,n=23,5,3,6,6,12,6,6 | 4 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein:To Normal or NC,n=23,5,3,6,6,12,6,6 | 4 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To Normal or NC,n=23,5,3,6,6,12,6,6 | 5 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To High,n=23,5,3,6,6,12,6,6 | 1 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To Normal or NC,n=23,5,3,6,6,12,6,6 | 6 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To Normal or NC,n=23,5,3,6,6,12,6,6 | 11 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin:ToNormal or NC,n=23,5,3,6,6,12,6,6 | 11 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides:To Normal or NC,n=23,5,3,6,6,12,6,6 | 12 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL:To Normal or NC,n=23,5,3,6,6,12,6,6 | 11 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin: To High,n=23,5,3,6,6,12,6,6 | 1 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL: To High,n=23,5,3,6,6,12,6,6 | 1 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To Normal or NC,n=23,5,3,6,6,12,6,6 | 12 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein: To Low,n=23,5,3,6,6,12,6,6 | 3 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein:To Normal or NC,n=23,5,3,6,6,12,6,6 | 9 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB:To Normal or NC,n=23,5,3,6,6,12,6,6 | 12 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To High,n=23,5,3,6,6,12,6,6 | 1 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To Normal or NC,n=23,5,3,6,6,12,6,6 | 10 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To Normal or NC,n=23,5,3,6,6,12,6,6 | 12 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To Normal or NC,n=23,5,3,6,6,12,6,6 | 12 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To Low,n=23,5,3,6,4,12,6,6 | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To Normal or NC,n=23,5,3,6,6,12,6,6 | 12 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To Normal or NC,n=23,5,3,6,4,12,6,6 | 4 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To High,n=23,5,3,6,6,12,6,6 | 2 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To High,n=23,5,3,6,4,12,6,6 | 8 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To Normal or NC,n=23,5,3,6,6,12,6,6 | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To Normal or NC,n=23,5,3,6,6,12,6,6 | 5 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To High,n=23,5,3,6,6,12,6,6 | 1 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL:To Normal or NC,n=23,5,3,6,6,12,6,6 | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To High,n=23,5,3,6,4,12,6,6 | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To Normal or NC,n=23,5,3,6,6,12,6,6 | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To High,n=23,5,3,6,6,12,6,6 | 1 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB:To Normal or NC,n=23,5,3,6,6,12,6,6 | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin:ToNormal or NC,n=23,5,3,6,6,12,6,6 | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To Normal or NC,n=23,5,3,6,4,12,6,6 | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein: To Low,n=23,5,3,6,6,12,6,6 | 1 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To Normal or NC,n=23,5,3,6,6,12,6,6 | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein:To Normal or NC,n=23,5,3,6,6,12,6,6 | 5 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To Normal or NC,n=23,5,3,6,6,12,6,6 | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides:To Normal or NC,n=23,5,3,6,6,12,6,6 | 3 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides: To High,n=23,5,3,6,6,12,6,6 | 3 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To Low,n=23,5,3,6,4,12,6,6 | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To Normal or NC,n=23,5,3,6,6,12,6,6 | 5 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To Normal or NC,n=23,5,3,6,6,12,6,6 | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To Normal or NC,n=23,5,3,6,6,12,6,6 | 4 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To Normal or NC,n=23,5,3,6,4,12,6,6 | 5 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To High,n=23,5,3,6,4,12,6,6 | 1 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides:To Normal or NC,n=23,5,3,6,6,12,6,6 | 4 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin:ToNormal or NC,n=23,5,3,6,6,12,6,6 | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To Normal or NC,n=23,5,3,6,6,12,6,6 | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To Normal or NC,n=23,5,3,6,6,12,6,6 | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To High,n=23,5,3,6,6,12,6,6 | 2 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein: To Low,n=23,5,3,6,6,12,6,6 | 1 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL:To Normal or NC,n=23,5,3,6,6,12,6,6 | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To Normal or NC,n=23,5,3,6,6,12,6,6 | 4 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To High,n=23,5,3,6,6,12,6,6 | 2 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To Low,n=23,5,3,6,4,12,6,6 | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein:To Normal or NC,n=23,5,3,6,6,12,6,6 | 5 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides: To High,n=23,5,3,6,6,12,6,6 | 2 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To Normal or NC,n=23,5,3,6,6,12,6,6 | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB:To Normal or NC,n=23,5,3,6,6,12,6,6 | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To Low,n=23,5,3,6,6,12,6,6 | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin: To High,n=23,5,3,6,6,12,6,6 | 0 Participants |
Primary
Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Blood samples collected for analysis of hematology parameters. PCI ranges were \>0.54 proportion of red blood cells in blood (hematocrit), \>180 grams/liter (hemoglobin), \<0.8 \*10\^9 cells/L (lymphocyte count), \<1.5 \*10\^9 cells/L (total absolute neutrophil count \[ANC\]), \<100 or \>550 \*10\^9 cells/L (platelet count), and \<3 or \>20\*10\^9 cells/L (white blood cell \[WBC\] count). Participants were counted in worst case category that their value changes to (low, within range or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in To within Range or No Change category. Participants were counted twice if the participant had values that changed To Low and To High, so the percentages may not add to 100%.
Time frame: Up to Day 193
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To within Range or No Change | 23 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To within Range or No Change | 21 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To within Range or No Change | 23 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To High | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To High | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To Low | 2 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To Low | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To Low | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To High | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To High | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To Low | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To within Range or No Change | 23 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To within Range or No Change | 23 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To Low | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To High | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To High | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To Low | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To within Range or No Change | 23 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To within Range or No Change | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To within Range or No Change | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To within Range or No Change | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To within Range or No Change | 4 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To within Range or No Change | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To Low | 1 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To within Range or No Change | 5 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To High | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To Low | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To within Range or No Change | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To within Range or No Change | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To within Range or No Change | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To High | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To Low | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To Low | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To Low | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To within Range or No Change | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To High | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To High | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To within Range or No Change | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To Low | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To High | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To within Range or No Change | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To Low | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To High | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To High | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To High | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To Low | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To Low | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To Low | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To High | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To Low | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To High | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To High | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To Low | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To Low | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To High | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To Low | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To Low | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To High | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To Low | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To High | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To Low | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To High | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To Low | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To High | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To Low | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To High | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To High | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To within Range or No Change | 12 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To High | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To within Range or No Change | 12 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To High | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To Low | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To High | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To Low | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To within Range or No Change | 10 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To within Range or No Change | 12 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To within Range or No Change | 12 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To High | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To Low | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To Low | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To High | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To High | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To Low | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To Low | 2 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To within Range or No Change | 12 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To High | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To Low | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To High | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To Low | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To Low | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To High | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To High | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To High | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To Low | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To High | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To Low | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To Low | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To Low | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To High | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To High | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To High | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To Low | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To Low | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To High | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To Low | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To High | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To Low | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To High | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To Low | 0 Participants |
Primary
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Hematology parameters assessed were activated partial thromboplastin time (APTT) (\<25 or \>37 seconds), basophil count (\<0.0 or \>0.1\*10\^9 cells/L), eosinophil count (\<0.0 or \>0.4\*10\^9 cells/L), fibrinogen (\<1.5 or \>4.0 g/L), mean corpuscle hemoglobin (MCH) (\<26.0 or \>33.5 picogram), mean corpuscle volume (MCV) (\<80 or \>99 femtoliter), monocyte count (\<0.2 or \>1.0\*10\^9 cells/L), prothrombin time (PT) (\<10 or \>12 seconds), red blood cell (RBC) count (\<4.4 or \>5.8\*10\^12 cells/L) and reticulocyte count (\<0.38 or \>2.64 percentage of reticulocytes). Participants were counted in worst case category that their value changes to (low, normal or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g., High to High) or whose value became normal, are recorded in To Normal or NC category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%.
Time frame: Up to Day 193
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To Normal or NC | 23 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To High | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To Normal or NC | 22 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To Low | 1 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To Low | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To High | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To High | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To Low | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To Low | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To Low | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To High | 2 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To Normal or NC | 21 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To Low | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To Normal or NC | 19 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To High | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To High | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To Normal or NC | 23 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To High | 4 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To Normal or NC | 23 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To Low | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To High | 2 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To Normal or NC | 21 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To Low | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To Normal or NC | 23 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To Low | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To Normal or NC | 23 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To High | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To Normal or NC | 23 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To Low | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To Normal or NC | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To Normal or NC | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To Normal or NC | 4 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To Normal or NC | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To High | 1 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To Normal or NC | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To Normal or NC | 4 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To High | 1 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To Normal or NC | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To Normal or NC | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To Normal or NC | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To Normal or NC | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To High | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To High | 1 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To High | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To Low | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To Normal or NC | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To High | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To Low | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To Normal or NC | 2 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To Low | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To Normal or NC | 2 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To High | 1 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To Low | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To Normal or NC | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To High | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To Low | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To Normal or NC | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To Low | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To Normal or NC | 2 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To High | 1 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To Low | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To Normal or NC | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To High | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To Low | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To Normal or NC | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To High | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To Low | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To Normal or NC | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To High | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To Low | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To Normal or NC | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To High | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To Low | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To Low | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To Normal or NC | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To Normal or NC | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To Low | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To Low | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To Low | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To High | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To Normal or NC | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To High | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To High | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To Normal or NC | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To Low | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To Low | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To High | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To High | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To Normal or NC | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To Low | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To Normal or NC | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To High | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To High | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To Low | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To Normal or NC | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To High | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To Normal or NC | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To Normal or NC | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To Normal or NC | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To Low | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To High | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To High | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To Normal or NC | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To Low | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To Normal or NC | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To Normal or NC | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To High | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To Low | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To Low | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To Low | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To Low | 1 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To Normal or NC | 4 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To High | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To High | 1 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To Low | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To Normal or NC | 5 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To Normal or NC | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To High | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To High | 1 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To Low | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To Low | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To Normal or NC | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To Normal or NC | 5 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To High | 1 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To Low | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To High | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To Normal or NC | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To High | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To Low | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To Normal or NC | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To High | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To High | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To Low | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To Low | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To High | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To Normal or NC | 12 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To Normal or NC | 6 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To Normal or NC | 11 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To Normal or NC | 12 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To High | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To Low | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To Normal or NC | 12 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To High | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To Normal or NC | 12 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To High | 6 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To Low | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To High | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To High | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To High | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To Low | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To High | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To Low | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To Normal or NC | 12 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To High | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To Low | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To Low | 1 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To High | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To Low | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To Normal or NC | 12 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To Low | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To Normal or NC | 12 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To Normal or NC | 12 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To High | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To Normal or NC | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To Normal or NC | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To High | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To Normal or NC | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To Low | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To Normal or NC | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To Low | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To Low | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To High | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To High | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To Low | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To Normal or NC | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To Low | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To High | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To Low | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To Low | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To High | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To Normal or NC | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To Normal or NC | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To Normal or NC | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To Low | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To High | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To High | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To High | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To Normal or NC | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To High | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To Low | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To Low | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To Normal or NC | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To Low | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To Low | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To Low | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To High | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To Low | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To Normal or NC | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To High | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To High | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To Low | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To Low | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To Normal or NC | 5 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To Normal or NC | 5 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To Low | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To High | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To Normal or NC | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To Normal or NC | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To High | 1 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To Low | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To High | 1 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To Normal or NC | 5 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To Normal or NC | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To Normal or NC | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To Low | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To High | 1 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To Low | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To High | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To Normal or NC | 4 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To High | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To High | 2 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To Normal or NC | 6 Participants |
Primary
Part A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings
Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF) intervals. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline abnormal ECG findings have been presented.
Time frame: Up to Day 193
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal - not clinically significant | 6 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal - clinically significant | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal - not clinically significant | 1 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal - clinically significant | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal - not clinically significant | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal - clinically significant | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal - not clinically significant | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal - clinically significant | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal - clinically significant | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal - not clinically significant | 3 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal - clinically significant | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal - not clinically significant | 2 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal - clinically significant | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal - not clinically significant | 3 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal - not clinically significant | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal - clinically significant | 0 Participants |
Primary
Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Vital signs included systolic blood pressure(SBP), diastolic blood pressure(DBP), heart rate, respiratory rate and body temperature and were measured in a semi-supine position after 5 minutes rest. PCI ranges were, SBP (millimeters of mercury \[mmHg\]): \<85 (low) or \>160 (high), DBP (mmHg): \<45 (low) or \>100 (high), heart rate (beats per minute): \<40 (low) or \>110 (high), respiration rate (breaths per minute): \<11(low) or \>20(high) and body temperature (degrees Celsius) \<35.5 (low) or \>38.0 (high). Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants whose vital signs value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the To within Range or No Change category. Participants were counted twice if the participant had values that changed To Low and To High, so the percentages may not add to 100%.
Time frame: Up to Day 193
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To within Range or No Change | 23 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To Low | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To Low | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To Low | 1 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To within Range or No Change | 23 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To High | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To within Range or No Change | 22 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To High | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To High | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To within Range or No Change | 23 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To Low | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To High | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To High | 1 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To Low | 0 Participants |
| Part A: Placebo SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To within Range or No Change | 22 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To within Range or No Change | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To within Range or No Change | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To within Range or No Change | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To within Range or No Change | 5 Participants |
| Part A: GSK3358699 1 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To within Range or No Change | 5 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To within Range or No Change | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To within Range or No Change | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To within Range or No Change | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To Low | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To High | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To High | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To High | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To Low | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To High | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To Low | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To High | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To within Range or No Change | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To within Range or No Change | 3 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To Low | 0 Participants |
| Part A: GSK3358699 3 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To Low | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To Low | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To High | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To Low | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To High | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To within Range or No Change | 5 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To High | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To Low | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To High | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To Low | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To High | 0 Participants |
| Part A: GSK3358699 10 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To Low | 1 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To High | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To Low | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To Low | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To High | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To Low | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To Low | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To High | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To High | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To High | 0 Participants |
| Part A: GSK3358699 20 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To Low | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To High | 1 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To High | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To Low | 1 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To within Range or No Change | 12 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To Low | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To Low | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To within Range or No Change | 11 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To within Range or No Change | 12 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To within Range or No Change | 12 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To within Range or No Change | 11 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To Low | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To Low | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To High | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To High | 0 Participants |
| Part A: GSK3358699 25 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To High | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To Low | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To High | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To High | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To Low | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To Low | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To High | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To High | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To High | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To Low | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To Low | 0 Participants |
| Part A: GSK3358699 30 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To High | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To High | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To High | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To Low | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To Low | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To Low | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To Low | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To High | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To High | 0 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To within Range or No Change | 6 Participants |
| Part A: GSK3358699 40 mg SD | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To Low | 0 Participants |
Primary
Part B: Number of Participants With Abnormal Urinalysis Parameters
Urine samples were planned to be collected to analyze urine parameters.
Time frame: Up to Day 30
Population: Safety Population. Data was not collected as no participants were enrolled in Part B.
Primary
Part B: Number of Participants With AEs and 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 medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, important medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed before.
Time frame: Up to Day 30
Population: Safety Population. Data was not collected as no participants were enrolled in Part B.
Primary
Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline
Blood samples were planned to be collected to analyze the chemistry parameters.
Time frame: Up to Day 30
Population: Safety Population. Data was not collected as no participants were enrolled in Part B.
Primary
Part B: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Blood samples were planned to be collected to analyze the chemistry parameters.
Time frame: Up to Day 30
Population: Safety Population. Data was not collected as no participants were enrolled in Part B.
Primary
Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Blood samples were planned to be collected to analyze hematology parameters.
Time frame: Up to Day 30
Population: Safety Population. Data was not collected as no participants were enrolled in Part B.
Primary
Part B: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Blood samples were planned to be collected to analyze hematology parameters.
Time frame: Up to Day 30
Population: Safety Population. Data was not collected as no participants were enrolled in Part B.
Primary
Part B: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings
Twelve lead ECGs were planned to be performed to measure PR interval, QRS duration, QT interval and QTcF.
Time frame: Up to Day 30
Population: Safety Population. Data was not collected as no participants were enrolled in Part B.
Primary
Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Vital signs were planned to be measured in a semi-supine position after 5 minutes of rest.
Time frame: Up to Day 30
Population: Safety Population. Data was not collected as no participants were enrolled in Part B.
Primary
Part C: Number of Participants With Abnormal Urinalysis Parameters
Urine samples were collected from participants for analyzing the following urine parameters: pH and glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocytes levels by dipstick. Urine samples showing any abnormality were sent for microscopic examination to detect the presence of RBC, WBC, cellular casts, granular casts, hyaline casts, and were counted as cells/HPF. Number of participants with abnormal urinalysis result by microscopic examination have been presented.
Time frame: Up to Day 28
Population: Safety Population. Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo SD | Part C: Number of Participants With Abnormal Urinalysis Parameters | WBC | 1 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Abnormal Urinalysis Parameters | Granular casts | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Abnormal Urinalysis Parameters | RBC | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Abnormal Urinalysis Parameters | Hyaline casts | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Abnormal Urinalysis Parameters | Cellular casts | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Abnormal Urinalysis Parameters | Hyaline casts | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Abnormal Urinalysis Parameters | RBC | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Abnormal Urinalysis Parameters | WBC | 1 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Abnormal Urinalysis Parameters | Cellular casts | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Abnormal Urinalysis Parameters | Granular casts | 0 Participants |
Primary
Part C: Number of Participants With AEs and 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 medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, important medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed before.
Time frame: Up to Day 49
Population: Safety Population. Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo SD | Part C: Number of Participants With AEs and SAEs | AEs | 7 Participants |
| Part A: Placebo SD | Part C: Number of Participants With AEs and SAEs | SAEs | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With AEs and SAEs | SAEs | 1 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With AEs and SAEs | AEs | 8 Participants |
Primary
Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline
Blood samples were collected for analysis of chemistry parameters. PCI ranges were \<30 g/L (albumin), \<2 or \>2.75 mmol/L (calcium), \>1.3\* ULN mmol/L (creatinine), \<3 or \>9 mmol/L (glucose), \<3 or \>5.5 mmol/L (potassium), and \<130 or \>150 mmol/L (sodium). Participants were counted in worst case category that their value changes to (low, within range or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in To within Range or No Change category. Participants were counted twice if participant had values that changed To Low and To High, so the percentages may not add to 100%.
Time frame: Up to Day 28
Population: Safety Population. Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Calcium: To within Range or No Change | 11 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Glucose: To Low | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Albumin: To High | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Glucose: To within Range or No Change | 11 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Calcium: To High | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Glucose: To High | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Albumin: To within Range or No Change | 11 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Potassium: To Low | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Creatinine: To Low | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Potassium: To within Range or No Change | 11 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Calcium: To Low | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Potassium: To High | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Creatinine: To within Range or No Change | 11 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Sodium: To Low | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Albumin: To Low | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Sodium: To within Range or No Change | 11 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Sodium: To High | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Creatinine: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Sodium: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Albumin: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Albumin: To within Range or No Change | 14 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Albumin: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Calcium: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Calcium: To within Range or No Change | 14 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Calcium: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Creatinine: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Creatinine: To within Range or No Change | 14 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Creatinine: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Glucose: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Glucose: To within Range or No Change | 14 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Glucose: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Potassium: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Potassium: To within Range or No Change | 14 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Potassium: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Sodium: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline | Sodium: To within Range or No Change | 14 Participants |
Primary
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Clinical chemistry parameters assessed were ALT (\<10 or \>50 IU/L), ALP (\<40 or \>129 IU/L), AST (\<0 or \>37 IU/L), cholesterol (\<2.3 or \>4.9 mmol/L), DB (\<0 or \>5 mcmol/L), high DL (\<0.9 or \>1.5 mmol/L), CRP (\<0.0 or \>5.0 mg/liter), low DL (\<0 or \>3.0 mmol/L), total bilirubin (\<0 or \>20 mcmol/L), total protein (\<63 or \>83 grams/L), triglycerides (\<0 or \>2.3 mmol/L) and BUN (\<4.76 or \>23.24 mg/deciliter). Participants were counted in worst case category that their value changes to (low, normal or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g., High to High) or whose value became normal, are recorded in To Normal or NC category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%.
Time frame: Up to Day 28
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein: To High,n=11,14,0,0,0 | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL:To Normal or NC,n=11,14,0,0,0 | 10 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides: To Low,n=11,14,0,0,0 | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To Low,n=11,14,0,0,0 | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides:To Normal or NC,n=11,14,0,0,0 | 10 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB: To High,n=11,14,0,0,0 | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides: To High,n=11,14,0,0,0 | 1 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To Normal or NC,n=11,14,0,0,0 | 8 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To Low,n=11,14,0,0,0 | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL: To High,n=11,14,0,0,0 | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To Normal or NC,n=11,14,0,0,0 | 11 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To High,n=11,14,0,0,0 | 3 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To High,n=11,14,0,0,0 | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB:To Normal or NC,n=11,14,0,0,0 | 11 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To Low,n=11,14,0,0,0 | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin: To Low,n=11,14,0,0,0 | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To Normal or NC,n=11,14,0,0,0 | 11 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To Low,n=10,13,0,0,0 | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To High,n=11,14,0,0,0 | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin:ToNormal or NC,n=11,14,0,0,0 | 11 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To Low,n=11,14,0,0,0 | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL: To Low,n=11,14,0,0,0 | 1 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To Normal or NC,n=11,14,0,0,0 | 11 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin: To High,n=11,14,0,0,0 | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To High,n=11,14,0,0,0 | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To Normal or NC,n=10,13,0,0,0 | 9 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To Low,n=11,14,0,0,0 | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein: To Low,n=11,14,0,0,0 | 1 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To Normal or NC,n=11,14,0,0,0 | 10 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB: To Low,n=11,14,0,0,0 | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To High,n=11,14,0,0,0 | 1 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein:To Normal or NC,n=11,14,0,0,0 | 10 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To Low,n=11,14,0,0,0 | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To High,n=10,13,0,0,0 | 1 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To Normal or NC,n=11,14,0,0,0 | 9 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To High,n=11,14,0,0,0 | 2 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To Normal or NC,n=11,14,0,0,0 | 13 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To High,n=11,14,0,0,0 | 1 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB: To Low,n=11,14,0,0,0 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB:To Normal or NC,n=11,14,0,0,0 | 14 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | DB: To High,n=11,14,0,0,0 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL: To Low,n=11,14,0,0,0 | 1 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL:To Normal or NC,n=11,14,0,0,0 | 13 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | High DL: To High,n=11,14,0,0,0 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To Low,n=10,13,0,0,0 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To Normal or NC,n=10,13,0,0,0 | 12 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | CRP: To High,n=10,13,0,0,0 | 1 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To Low,n=11,14,0,0,0 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To Normal or NC,n=11,14,0,0,0 | 13 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Low DL: To High,n=11,14,0,0,0 | 1 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin: To Low,n=11,14,0,0,0 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin:ToNormal or NC,n=11,14,0,0,0 | 14 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total bilirubin: To High,n=11,14,0,0,0 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein: To Low,n=11,14,0,0,0 | 2 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein:To Normal or NC,n=11,14,0,0,0 | 12 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Total protein: To High,n=11,14,0,0,0 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides: To Low,n=11,14,0,0,0 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides:To Normal or NC,n=11,14,0,0,0 | 13 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Triglycerides: To High,n=11,14,0,0,0 | 1 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To Low,n=11,14,0,0,0 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To Normal or NC,n=11,14,0,0,0 | 14 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN: To High,n=11,14,0,0,0 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To Low,n=11,14,0,0,0 | 1 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To Normal or NC,n=11,14,0,0,0 | 12 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT: To High,n=11,14,0,0,0 | 1 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To Low,n=11,14,0,0,0 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To Normal or NC,n=11,14,0,0,0 | 14 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALP: To High,n=11,14,0,0,0 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To Low,n=11,14,0,0,0 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To Normal or NC,n=11,14,0,0,0 | 14 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST: To High,n=11,14,0,0,0 | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Cholesterol: To Low,n=11,14,0,0,0 | 0 Participants |
Primary
Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Blood samples were collected for analysis of hematology parameters. PCI ranges were \>0.54 proportion of red blood cells in blood (hematocrit), \>180 grams/liter (hemoglobin), \<0.8\*10\^9 cells/L (lymphocyte count), \<1.5\*10\^9 cells/L (total ANC), \<100 or \>550\*10\^9 cells/L (platelet count), and \<3 or \>20\*10\^9 cells/L (WBC count). Participants were counted in worst case category that their value changes to (low, within range or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in To within Range or No Change category. Participants were counted twice if the participant had values that changed To Low and To High, so the percentages may not add to 100%.
Time frame: Up to Day 28
Population: Safety Population. Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To Low | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To within Range or No Change | 11 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To High | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To Low | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To within Range or No Change | 11 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To High | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To Low | 1 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To within Range or No Change | 10 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To High | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To Low | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To within Range or No Change | 11 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To High | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To Low | 1 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To within Range or No Change | 10 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To High | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To Low | 1 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To within Range or No Change | 10 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To within Range or No Change | 14 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To within Range or No Change | 14 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To within Range or No Change | 14 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To within Range or No Change | 14 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Platelet count: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To within Range or No Change | 13 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Total ANC: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To within Range or No Change | 14 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | WBC: To Low | 1 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline | Lymphocyte count: To High | 0 Participants |
Primary
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Hematology parameters assessed were APTT (\<25 or \>37 seconds), basophil count (\<0.0 or \>0.1\*10\^9 cells/L), eosinophil count (\<0.0 or \>0.4\*10\^9 cells/L), fibrinogen (\<1.5 or \>4.0 g/L), MCH (\<26.0 or \>33.5 picogram), MCV (\<80 or \>99 femtoliter), monocyte count (\<0.2 or \>1.0\*10\^9 cells/L), PT (\<10 or \>12 seconds), RBC count (\<4.4 or \>5.8\*10\^12 cells/L) and reticulocyte count (\<0.38 or \>2.64 percentage of reticulocytes). Participants were counted in worst case category that their value changes to (low, normal or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g., High to High) or whose value became normal, are recorded in To Normal or NC category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%.
Time frame: Up to Day 28
Population: Safety Population. Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To Low | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To High | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To Normal or NC | 11 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To Normal or NC | 10 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To High | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To Low | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To Low | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To High | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To Normal or NC | 11 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To Normal or NC | 11 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To High | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To Low | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To Low | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To High | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To Normal or NC | 10 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To Low | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To High | 1 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To Low | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To Low | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To High | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To Normal or NC | 11 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To Normal or NC | 11 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To High | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To Normal or NC | 11 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To Low | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To High | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To Normal or NC | 11 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To Normal or NC | 11 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To High | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To Low | 1 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To Normal or NC | 13 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | APTT: To High | 1 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To Normal or NC | 14 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophil count: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To Normal or NC | 14 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophil count: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To Normal or NC | 14 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Fibrinogen: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To Normal or NC | 14 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To Normal or NC | 14 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To Normal or NC | 14 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocyte count: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To Normal or NC | 14 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | PT: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To Low | 1 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To Normal or NC | 13 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | RBC: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Reticulocyte count: To Normal or NC | 14 Participants |
Primary
Part C: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings
Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QTcF intervals. Abnormal findings were categorized as clinically significant and not clinically significant. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline abnormal ECG findings have been presented.
Time frame: Up to Day 28
Population: Safety Population. Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings | Abnormal - not clinically significant | 2 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings | Abnormal - clinically significant | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings | Abnormal - not clinically significant | 3 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings | Abnormal - clinically significant | 1 Participants |
Primary
Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Vital signs included SBP, DBP, heart rate, respiratory rate and body temperature and were measured in a semi-supine position after 5 minutes rest. PCI ranges were, SBP (mmHg): \<85 (low) or \>160 (high), DBP (mmHg): \<45 (low) or \>100 (high), heart rate (beats per minute): \<40 (low) or \>110 (high), respiration rate (breaths per minute): \<11 (low) or \>20 (high) and body temperature (degrees Celsius) \<35.5 (low) or \>38.0 (high). Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants whose vital signs value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the To within Range or No Change category. Participants were counted twice if the participant had values that changed To Low and To High, so the percentages may not add to 100%.
Time frame: Up to Day 49
Population: Safety Population. Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To High | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To within Range or No Change | 10 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To Low | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To Low | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To Low | 1 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To within Range or No Change | 11 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To within Range or No Change | 9 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To Low | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To High | 1 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To High | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To Low | 0 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To within Range or No Change | 11 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To within Range or No Change | 11 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To High | 1 Participants |
| Part A: Placebo SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To Low | 1 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To within Range or No Change | 14 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | SBP: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To within Range or No Change | 14 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | DBP: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To within Range or No Change | 13 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Heart rate: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To Low | 1 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To within Range or No Change | 13 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Respiratory rate: To High | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To Low | 0 Participants |
| Part A: GSK3358699 1 mg SD | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline | Body temperature: To within Range or No Change | 14 Participants |
Secondary
Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation
Whole blood samples of 1 milliliter (mL) were collected in TruCulture tubes, containing LPS and incubated for 24 hours, post which the inflammatory mediators (MCP-1, IL-6 and TNF alpha) were analyzed.
Time frame: Day 1: 1, 4, 8, 12, 24 and 48 hours
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for GSK3358699 25 mg SD arm.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Placebo SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 48 hours, n=17,5,3,6,6,0,6,6 | 3445.95 Picogram per milliliter |
| Part A: Placebo SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 24 hours, n=17,5,3,6,6,0,6,6 | 1662.28 Picogram per milliliter |
| Part A: Placebo SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 4 hours, n=17,5,3,6,6,0,6,6 | 13092.01 Picogram per milliliter |
| Part A: Placebo SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 12 hour, n=17,5,3,6,6,0,6,6 | 4206.18 Picogram per milliliter |
| Part A: Placebo SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 12 hour, n=17,5,3,6,6,0,6,6 | 1791.07 Picogram per milliliter |
| Part A: Placebo SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 4 hours, n=17,5,3,6,6,0,6,6 | 3189.81 Picogram per milliliter |
| Part A: Placebo SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 1 hour, n=17,5,3,6,6,0,6,6 | 10352.87 Picogram per milliliter |
| Part A: Placebo SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 8 hours, n=17,5,3,6,6,0,6,6 | 1300.34 Picogram per milliliter |
| Part A: Placebo SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 4 hours, n=17,5,3,6,6,0,6,6 | 1748.71 Picogram per milliliter |
| Part A: Placebo SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 48 hours, n=17,5,3,6,6,0,6,6 | 13204.84 Picogram per milliliter |
| Part A: Placebo SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 24 hours, n=17,5,3,6,6,0,6,6 | 12876.74 Picogram per milliliter |
| Part A: Placebo SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 24 hours, n=17,5,3,5,6,0,6,6 | 3164.79 Picogram per milliliter |
| Part A: Placebo SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 8 hours, n=17,5,3,6,6,0,6,6 | 3673.78 Picogram per milliliter |
| Part A: Placebo SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 48 hours, n=17,5,3,6,6,0,6,6 | 1398.36 Picogram per milliliter |
| Part A: Placebo SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 12 hour, n=17,5,3,6,6,0,6,6 | 15125.82 Picogram per milliliter |
| Part A: Placebo SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 8 hours, n=17,5,3,6,6,0,6,6 | 12560.83 Picogram per milliliter |
| Part A: Placebo SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 1 hour, n=17,5,3,6,6,0,6,6 | 2525.78 Picogram per milliliter |
| Part A: Placebo SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 1 hour, n=17,5,2,6,6,0,6,6 | 2107.38 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 12 hour, n=17,5,3,6,6,0,6,6 | 2738.20 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 4 hours, n=17,5,3,6,6,0,6,6 | 2638.95 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 8 hours, n=17,5,3,6,6,0,6,6 | 2911.87 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 24 hours, n=17,5,3,5,6,0,6,6 | 4528.14 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 4 hours, n=17,5,3,6,6,0,6,6 | 3452.27 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 48 hours, n=17,5,3,6,6,0,6,6 | 4077.77 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 8 hours, n=17,5,3,6,6,0,6,6 | 3630.47 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 1 hour, n=17,5,3,6,6,0,6,6 | 15208.12 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 1 hour, n=17,5,3,6,6,0,6,6 | 2281.20 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 4 hours, n=17,5,3,6,6,0,6,6 | 13851.61 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 12 hour, n=17,5,3,6,6,0,6,6 | 3680.34 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 8 hours, n=17,5,3,6,6,0,6,6 | 13629.60 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 12 hour, n=17,5,3,6,6,0,6,6 | 13890.39 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 48 hours, n=17,5,3,6,6,0,6,6 | 2306.83 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 24 hours, n=17,5,3,6,6,0,6,6 | 16961.79 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 48 hours, n=17,5,3,6,6,0,6,6 | 16209.14 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 24 hours, n=17,5,3,6,6,0,6,6 | 2349.62 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 1 hour, n=17,5,2,6,6,0,6,6 | 2997.62 Picogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 24 hours, n=17,5,3,6,6,0,6,6 | 23634.22 Picogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 8 hours, n=17,5,3,6,6,0,6,6 | 28805.81 Picogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 8 hours, n=17,5,3,6,6,0,6,6 | 9631.19 Picogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 12 hour, n=17,5,3,6,6,0,6,6 | 28948.13 Picogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 24 hours, n=17,5,3,6,6,0,6,6 | 2216.41 Picogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 8 hours, n=17,5,3,6,6,0,6,6 | 3145.66 Picogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 12 hour, n=17,5,3,6,6,0,6,6 | 8736.93 Picogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 4 hours, n=17,5,3,6,6,0,6,6 | 3381.52 Picogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 48 hours, n=17,5,3,6,6,0,6,6 | 27160.99 Picogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 1 hour, n=17,5,3,6,6,0,6,6 | 20385.25 Picogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 12 hour, n=17,5,3,6,6,0,6,6 | 3048.56 Picogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 24 hours, n=17,5,3,5,6,0,6,6 | 4694.58 Picogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 1 hour, n=17,5,3,6,6,0,6,6 | 4340.00 Picogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 48 hours, n=17,5,3,6,6,0,6,6 | 1621.46 Picogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 48 hours, n=17,5,3,6,6,0,6,6 | 10364.95 Picogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 4 hours, n=17,5,3,6,6,0,6,6 | 3774.02 Picogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 4 hours, n=17,5,3,6,6,0,6,6 | 19431.61 Picogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 1 hour, n=17,5,2,6,6,0,6,6 | 2539.15 Picogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 4 hours, n=17,5,3,6,6,0,6,6 | 15636.75 Picogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 12 hour, n=17,5,3,6,6,0,6,6 | 2003.41 Picogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 8 hours, n=17,5,3,6,6,0,6,6 | 16564.79 Picogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 48 hours, n=17,5,3,6,6,0,6,6 | 1729.87 Picogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 24 hours, n=17,5,3,5,6,0,6,6 | 5576.01 Picogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 4 hours, n=17,5,3,6,6,0,6,6 | 1410.01 Picogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 12 hour, n=17,5,3,6,6,0,6,6 | 18712.82 Picogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 12 hour, n=17,5,3,6,6,0,6,6 | 5139.53 Picogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 8 hours, n=17,5,3,6,6,0,6,6 | 1606.85 Picogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 24 hours, n=17,5,3,6,6,0,6,6 | 14387.39 Picogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 8 hours, n=17,5,3,6,6,0,6,6 | 4612.79 Picogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 24 hours, n=17,5,3,6,6,0,6,6 | 1691.59 Picogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 1 hour, n=17,5,2,6,6,0,6,6 | 1273.19 Picogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 1 hour, n=17,5,3,6,6,0,6,6 | 3455.53 Picogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 1 hour, n=17,5,3,6,6,0,6,6 | 12820.72 Picogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 48 hours, n=17,5,3,6,6,0,6,6 | 4186.10 Picogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 48 hours, n=17,5,3,6,6,0,6,6 | 14786.71 Picogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 4 hours, n=17,5,3,6,6,0,6,6 | 4493.55 Picogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 48 hours, n=17,5,3,6,6,0,6,6 | 13685.44 Picogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 12 hour, n=17,5,3,6,6,0,6,6 | 3079.37 Picogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 24 hours, n=17,5,3,5,6,0,6,6 | 3543.62 Picogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 48 hours, n=17,5,3,6,6,0,6,6 | 3963.40 Picogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 1 hour, n=17,5,3,6,6,0,6,6 | 15596.95 Picogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 4 hours, n=17,5,3,6,6,0,6,6 | 12900.07 Picogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 8 hours, n=17,5,3,6,6,0,6,6 | 17019.48 Picogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 12 hour, n=17,5,3,6,6,0,6,6 | 15622.25 Picogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 24 hours, n=17,5,3,6,6,0,6,6 | 12593.53 Picogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 1 hour, n=17,5,2,6,6,0,6,6 | 1278.42 Picogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 4 hours, n=17,5,3,6,6,0,6,6 | 1648.51 Picogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 8 hours, n=17,5,3,6,6,0,6,6 | 1533.33 Picogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 12 hour, n=17,5,3,6,6,0,6,6 | 1297.53 Picogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 24 hours, n=17,5,3,6,6,0,6,6 | 1062.86 Picogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 48 hours, n=17,5,3,6,6,0,6,6 | 1200.15 Picogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 1 hour, n=17,5,3,6,6,0,6,6 | 3916.76 Picogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 4 hours, n=17,5,3,6,6,0,6,6 | 2672.58 Picogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 8 hours, n=17,5,3,6,6,0,6,6 | 4908.42 Picogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 12 hour, n=17,5,3,6,6,0,6,6 | 2062.41 Picogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 1 hour, n=17,5,3,6,6,0,6,6 | 10057.64 Picogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 48 hours, n=17,5,3,6,6,0,6,6 | 14374.44 Picogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 8 hours, n=17,5,3,6,6,0,6,6 | 5233.22 Picogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 1 hour, n=17,5,3,6,6,0,6,6 | 1971.77 Picogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 12 hour, n=17,5,3,6,6,0,6,6 | 12305.88 Picogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 48 hours, n=17,5,3,6,6,0,6,6 | 3788.04 Picogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 24 hours, n=17,5,3,6,6,0,6,6 | 12894.02 Picogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 24 hours, n=17,5,3,5,6,0,6,6 | 3649.08 Picogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 8 hours, n=17,5,3,6,6,0,6,6 | 16486.96 Picogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 12 hour, n=17,5,3,6,6,0,6,6 | 2846.57 Picogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 4 hours, n=17,5,3,6,6,0,6,6 | 3618.72 Picogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 8 hours, n=17,5,3,6,6,0,6,6 | 2312.12 Picogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 48 hours, n=17,5,3,6,6,0,6,6 | 1595.51 Picogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 4 hours, n=17,5,3,6,6,0,6,6 | 2604.00 Picogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 24 hours, n=17,5,3,6,6,0,6,6 | 2275.17 Picogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 1 hour, n=17,5,2,6,6,0,6,6 | 1604.85 Picogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 4 hours, n=17,5,3,6,6,0,6,6 | 12074.28 Picogram per milliliter |
| Part A: GSK3358699 40 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 48 hours, n=17,5,3,6,6,0,6,6 | 8359.81 Picogram per milliliter |
| Part A: GSK3358699 40 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 12 hour, n=17,5,3,6,6,0,6,6 | 2270.49 Picogram per milliliter |
| Part A: GSK3358699 40 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 4 hours, n=17,5,3,6,6,0,6,6 | 7544.02 Picogram per milliliter |
| Part A: GSK3358699 40 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 24 hours, n=17,5,3,6,6,0,6,6 | 8705.59 Picogram per milliliter |
| Part A: GSK3358699 40 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 24 hours, n=17,5,3,6,6,0,6,6 | 1988.64 Picogram per milliliter |
| Part A: GSK3358699 40 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 12 hour, n=17,5,3,6,6,0,6,6 | 6754.46 Picogram per milliliter |
| Part A: GSK3358699 40 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 8 hours, n=17,5,3,6,6,0,6,6 | 8688.63 Picogram per milliliter |
| Part A: GSK3358699 40 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 8 hours, n=17,5,3,6,6,0,6,6 | 2934.21 Picogram per milliliter |
| Part A: GSK3358699 40 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 48 hours, n=17,5,3,6,6,0,6,6 | 1828.23 Picogram per milliliter |
| Part A: GSK3358699 40 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: IL6, 1 hour, n=17,5,3,6,6,0,6,6 | 5728.17 Picogram per milliliter |
| Part A: GSK3358699 40 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 48 hours, n=17,5,3,6,6,0,6,6 | 2404.11 Picogram per milliliter |
| Part A: GSK3358699 40 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 1 hour, n=17,5,3,6,6,0,6,6 | 1552.10 Picogram per milliliter |
| Part A: GSK3358699 40 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 24 hours, n=17,5,3,5,6,0,6,6 | 2741.96 Picogram per milliliter |
| Part A: GSK3358699 40 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 12 hour, n=17,5,3,6,6,0,6,6 | 1729.42 Picogram per milliliter |
| Part A: GSK3358699 40 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 4 hours, n=17,5,3,6,6,0,6,6 | 1643.37 Picogram per milliliter |
| Part A: GSK3358699 40 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 8 hours, n=17,5,3,6,6,0,6,6 | 1863.25 Picogram per milliliter |
| Part A: GSK3358699 40 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: MCP-1, 1 hour, n=17,5,2,6,6,0,6,6 | 1047.32 Picogram per milliliter |
| Part A: GSK3358699 40 mg SD | Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation | Day 1: TNF alpha, 4 hours, n=17,5,3,6,6,0,6,6 | 1876.55 Picogram per milliliter |
Secondary
Part A: Apparent Terminal Phase Half-life (t1/2) of GSK3358699
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period
Population: PK Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo SD | Part A: Apparent Terminal Phase Half-life (t1/2) of GSK3358699 | NA Hours |
| Part A: GSK3358699 1 mg SD | Part A: Apparent Terminal Phase Half-life (t1/2) of GSK3358699 | NA Hours |
| Part A: GSK3358699 3 mg SD | Part A: Apparent Terminal Phase Half-life (t1/2) of GSK3358699 | 2.44 Hours |
| Part A: GSK3358699 10 mg SD | Part A: Apparent Terminal Phase Half-life (t1/2) of GSK3358699 | 2.75 Hours |
| Part A: GSK3358699 20 mg SD | Part A: Apparent Terminal Phase Half-life (t1/2) of GSK3358699 | 6.02 Hours |
| Part A: GSK3358699 25 mg SD | Part A: Apparent Terminal Phase Half-life (t1/2) of GSK3358699 | 4.77 Hours |
| Part A: GSK3358699 30 mg SD | Part A: Apparent Terminal Phase Half-life (t1/2) of GSK3358699 | 6.88 Hours |
Secondary
Part A: Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) of GSK3358699
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours post-dose in each treatment period
Population: PK Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo SD | Part A: Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) of GSK3358699 | NA Hours*nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) of GSK3358699 | NA Hours*nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) of GSK3358699 | 13.17 Hours*nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) of GSK3358699 | 23.86 Hours*nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) of GSK3358699 | 32.69 Hours*nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) of GSK3358699 | 67.38 Hours*nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) of GSK3358699 | 59.05 Hours*nanogram per milliliter |
Secondary
Part A: Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-infinity]) of GSK3358699
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period
Population: PK Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo SD | Part A: Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-infinity]) of GSK3358699 | NA Hours*nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-infinity]) of GSK3358699 | NA Hours*nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-infinity]) of GSK3358699 | 13.20 Hours*nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-infinity]) of GSK3358699 | 23.89 Hours*nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-infinity]) of GSK3358699 | 33.22 Hours*nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-infinity]) of GSK3358699 | 69.13 Hours*nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-infinity]) of GSK3358699 | 59.68 Hours*nanogram per milliliter |
Secondary
Part A: Area Under the Plasma Concentration Curve From Time Zero to Last Time of Quantifiable Concentration (AUC[0-t]) of GSK3358699
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period
Population: PK Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo SD | Part A: Area Under the Plasma Concentration Curve From Time Zero to Last Time of Quantifiable Concentration (AUC[0-t]) of GSK3358699 | 0.74 Hours*nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Area Under the Plasma Concentration Curve From Time Zero to Last Time of Quantifiable Concentration (AUC[0-t]) of GSK3358699 | 2.33 Hours*nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Area Under the Plasma Concentration Curve From Time Zero to Last Time of Quantifiable Concentration (AUC[0-t]) of GSK3358699 | 10.77 Hours*nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Area Under the Plasma Concentration Curve From Time Zero to Last Time of Quantifiable Concentration (AUC[0-t]) of GSK3358699 | 23.40 Hours*nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Area Under the Plasma Concentration Curve From Time Zero to Last Time of Quantifiable Concentration (AUC[0-t]) of GSK3358699 | 31.88 Hours*nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Area Under the Plasma Concentration Curve From Time Zero to Last Time of Quantifiable Concentration (AUC[0-t]) of GSK3358699 | 66.38 Hours*nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Area Under the Plasma Concentration Curve From Time Zero to Last Time of Quantifiable Concentration (AUC[0-t]) of GSK3358699 | 58.09 Hours*nanogram per milliliter |
Secondary
Part A: AUC(0-24) of GSK3206944
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours post-dose in each treatment period
Population: PK Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo SD | Part A: AUC(0-24) of GSK3206944 | 16.44 Hours*nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: AUC(0-24) of GSK3206944 | 28.27 Hours*nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: AUC(0-24) of GSK3206944 | 106.55 Hours*nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: AUC(0-24) of GSK3206944 | 209.96 Hours*nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: AUC(0-24) of GSK3206944 | 374.49 Hours*nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: AUC(0-24) of GSK3206944 | 452.66 Hours*nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: AUC(0-24) of GSK3206944 | 586.70 Hours*nanogram per milliliter |
Secondary
Part A: AUC(0-infinity) of GSK3206944
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period
Population: PK Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo SD | Part A: AUC(0-infinity) of GSK3206944 | 17.08 Hours*nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: AUC(0-infinity) of GSK3206944 | 29.05 Hours*nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: AUC(0-infinity) of GSK3206944 | 108.29 Hours*nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: AUC(0-infinity) of GSK3206944 | 189.02 Hours*nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: AUC(0-infinity) of GSK3206944 | 357.98 Hours*nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: AUC(0-infinity) of GSK3206944 | 492.92 Hours*nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: AUC(0-infinity) of GSK3206944 | 649.74 Hours*nanogram per milliliter |
Secondary
Part A: AUC(0-t) of GSK3206944
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period
Population: PK Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo SD | Part A: AUC(0-t) of GSK3206944 | 15.16 Hours*nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: AUC(0-t) of GSK3206944 | 29.12 Hours*nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: AUC(0-t) of GSK3206944 | 106.55 Hours*nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: AUC(0-t) of GSK3206944 | 209.98 Hours*nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: AUC(0-t) of GSK3206944 | 381.16 Hours*nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: AUC(0-t) of GSK3206944 | 470.40 Hours*nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: AUC(0-t) of GSK3206944 | 630.63 Hours*nanogram per milliliter |
Secondary
Part A: Cmax of GSK3206944
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period
Population: PK Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo SD | Part A: Cmax of GSK3206944 | 3.28 Nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Cmax of GSK3206944 | 6.03 Nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Cmax of GSK3206944 | 19.39 Nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Cmax of GSK3206944 | 50.13 Nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Cmax of GSK3206944 | 71.67 Nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Cmax of GSK3206944 | 102.09 Nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Cmax of GSK3206944 | 121.22 Nanogram per milliliter |
Secondary
Part A: Maximum Plasma Concentration (Cmax) of GSK3358699
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period
Population: PK Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo SD | Part A: Maximum Plasma Concentration (Cmax) of GSK3358699 | 0.68 Nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Maximum Plasma Concentration (Cmax) of GSK3358699 | 1.95 Nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Maximum Plasma Concentration (Cmax) of GSK3358699 | 6.46 Nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Maximum Plasma Concentration (Cmax) of GSK3358699 | 16.10 Nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Maximum Plasma Concentration (Cmax) of GSK3358699 | 17.47 Nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Maximum Plasma Concentration (Cmax) of GSK3358699 | 64.48 Nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Maximum Plasma Concentration (Cmax) of GSK3358699 | 34.58 Nanogram per milliliter |
Secondary
Part A: Monocyte Intracellular Concentration of GSK3206944
Blood samples were collected into sodium heparin tubes for the isolation of monocytes and for measurement of GSK3206944 concentrations in monocytes. GSK3206944 is a metabolite of GSK3358699.
Time frame: Day 1: 1, 4, 8, 24 and 48 hours post-dose in each treatment period
Population: PK Population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Placebo SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 48 hours | NA Nanogram per milliliter |
| Part A: Placebo SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 24 hours | NA Nanogram per milliliter |
| Part A: Placebo SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 4 hours | NA Nanogram per milliliter |
| Part A: Placebo SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 1 hour | NA Nanogram per milliliter |
| Part A: Placebo SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 8 hours | NA Nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 24 hours | NA Nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 48 hours | NA Nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 8 hours | NA Nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 1 hour | NA Nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 4 hours | NA Nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 48 hours | NA Nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 24 hours | NA Nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 4 hours | NA Nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 8 hours | NA Nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 1 hour | 0.177 Nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 1 hour | 0.673 Nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 24 hours | NA Nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 8 hours | NA Nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 48 hours | NA Nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 4 hours | 0.105 Nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 48 hours | NA Nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 1 hour | NA Nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 4 hours | 0.149 Nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 24 hours | NA Nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 8 hours | NA Nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 1 hour | 1.243 Nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 4 hours | 0.277 Nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 8 hours | NA Nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 24 hours | NA Nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 48 hours | NA Nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 8 hours | NA Nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 4 hours | 0.297 Nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 1 hour | 1.410 Nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 48 hours | NA Nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 24 hours | NA Nanogram per milliliter |
Secondary
Part A: Plasma Concentrations of GSK3206944
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period
Population: PK Population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Placebo SD | Part A: Plasma Concentrations of GSK3206944 | 1 hour | 3.0310 Nanogram per milliliter |
| Part A: Placebo SD | Part A: Plasma Concentrations of GSK3206944 | 15 minutes | 0.2050 Nanogram per milliliter |
| Part A: Placebo SD | Part A: Plasma Concentrations of GSK3206944 | 4 hours | 1.9110 Nanogram per milliliter |
| Part A: Placebo SD | Part A: Plasma Concentrations of GSK3206944 | 8 hours | 0.5840 Nanogram per milliliter |
| Part A: Placebo SD | Part A: Plasma Concentrations of GSK3206944 | 2 hours | 3.2830 Nanogram per milliliter |
| Part A: Placebo SD | Part A: Plasma Concentrations of GSK3206944 | 6 hours | 0.9490 Nanogram per milliliter |
| Part A: Placebo SD | Part A: Plasma Concentrations of GSK3206944 | 24 hours | 0.0000 Nanogram per milliliter |
| Part A: Placebo SD | Part A: Plasma Concentrations of GSK3206944 | 30 minutes | 1.2090 Nanogram per milliliter |
| Part A: Placebo SD | Part A: Plasma Concentrations of GSK3206944 | Pre-dose | 0.0000 Nanogram per milliliter |
| Part A: Placebo SD | Part A: Plasma Concentrations of GSK3206944 | 48 hours | NA Nanogram per milliliter |
| Part A: Placebo SD | Part A: Plasma Concentrations of GSK3206944 | 12 hours | 0.2540 Nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Plasma Concentrations of GSK3206944 | 12 hours | 0.4670 Nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Plasma Concentrations of GSK3206944 | 24 hours | 0.1050 Nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Plasma Concentrations of GSK3206944 | 15 minutes | 0.2070 Nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Plasma Concentrations of GSK3206944 | Pre-dose | 0.000 Nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Plasma Concentrations of GSK3206944 | 8 hours | 1.0200 Nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Plasma Concentrations of GSK3206944 | 1 hour | 4.2200 Nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Plasma Concentrations of GSK3206944 | 30 minutes | 1.8410 Nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Plasma Concentrations of GSK3206944 | 2 hours | 5.5640 Nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Plasma Concentrations of GSK3206944 | 4 hours | 3.2490 Nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Plasma Concentrations of GSK3206944 | 48 hours | NA Nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Plasma Concentrations of GSK3206944 | 6 hours | 1.5760 Nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Plasma Concentrations of GSK3206944 | 6 hours | 6.7745 Nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Plasma Concentrations of GSK3206944 | 4 hours | 10.6790 Nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Plasma Concentrations of GSK3206944 | 15 minutes | 0.0550 Nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Plasma Concentrations of GSK3206944 | Pre-dose | 0.0000 Nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Plasma Concentrations of GSK3206944 | 24 hours | 0.2620 Nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Plasma Concentrations of GSK3206944 | 30 minutes | 3.1930 Nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Plasma Concentrations of GSK3206944 | 12 hours | 1.8400 Nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Plasma Concentrations of GSK3206944 | 1 hour | 17.1455 Nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Plasma Concentrations of GSK3206944 | 48 hours | 0.0000 Nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Plasma Concentrations of GSK3206944 | 8 hours | 4.6515 Nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Plasma Concentrations of GSK3206944 | 2 hours | 17.6535 Nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Plasma Concentrations of GSK3206944 | 4 hours | 22.6925 Nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Plasma Concentrations of GSK3206944 | Pre-dose | 0.0000 Nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Plasma Concentrations of GSK3206944 | 15 minutes | 0.0000 Nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Plasma Concentrations of GSK3206944 | 30 minutes | 1.8370 Nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Plasma Concentrations of GSK3206944 | 1 hour | 26.1280 Nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Plasma Concentrations of GSK3206944 | 2 hours | 46.4250 Nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Plasma Concentrations of GSK3206944 | 6 hours | 13.7955 Nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Plasma Concentrations of GSK3206944 | 8 hours | 8.3535 Nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Plasma Concentrations of GSK3206944 | 12 hours | 3.4535 Nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Plasma Concentrations of GSK3206944 | 24 hours | 0.4790 Nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Plasma Concentrations of GSK3206944 | 48 hours | 0.0000 Nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Plasma Concentrations of GSK3206944 | 2 hours | 70.4010 Nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Plasma Concentrations of GSK3206944 | Pre-dose | 0.0000 Nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Plasma Concentrations of GSK3206944 | 6 hours | 23.1275 Nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Plasma Concentrations of GSK3206944 | 1 hour | 33.6145 Nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Plasma Concentrations of GSK3206944 | 8 hours | 13.7165 Nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Plasma Concentrations of GSK3206944 | 30 minutes | 4.3810 Nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Plasma Concentrations of GSK3206944 | 48 hours | 0.3440 Nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Plasma Concentrations of GSK3206944 | 12 hours | 5.3830 Nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Plasma Concentrations of GSK3206944 | 15 minutes | 0.0000 Nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Plasma Concentrations of GSK3206944 | 24 hours | 1.2020 Nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Plasma Concentrations of GSK3206944 | 4 hours | 46.8165 Nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Plasma Concentrations of GSK3206944 | 8 hours | 16.5795 Nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Plasma Concentrations of GSK3206944 | 30 minutes | 17.2245 Nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Plasma Concentrations of GSK3206944 | Pre-dose | 0.0000 Nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Plasma Concentrations of GSK3206944 | 2 hours | 102.0865 Nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Plasma Concentrations of GSK3206944 | 4 hours | 51.7230 Nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Plasma Concentrations of GSK3206944 | 12 hours | 6.7365 Nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Plasma Concentrations of GSK3206944 | 15 minutes | 0.0575 Nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Plasma Concentrations of GSK3206944 | 48 hours | 0.1895 Nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Plasma Concentrations of GSK3206944 | 24 hours | 1.1015 Nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Plasma Concentrations of GSK3206944 | 6 hours | 30.4690 Nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Plasma Concentrations of GSK3206944 | 1 hour | 89.1965 Nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Plasma Concentrations of GSK3206944 | 24 hours | 1.5040 Nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Plasma Concentrations of GSK3206944 | 30 minutes | 6.3350 Nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Plasma Concentrations of GSK3206944 | 2 hours | 121.2220 Nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Plasma Concentrations of GSK3206944 | 48 hours | 0.2565 Nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Plasma Concentrations of GSK3206944 | Pre-dose | 0.0000 Nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Plasma Concentrations of GSK3206944 | 6 hours | 36.8305 Nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Plasma Concentrations of GSK3206944 | 1 hour | 74.5130 Nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Plasma Concentrations of GSK3206944 | 12 hours | 8.7280 Nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Plasma Concentrations of GSK3206944 | 15 minutes | 0.0000 Nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Plasma Concentrations of GSK3206944 | 8 hours | 18.4825 Nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Plasma Concentrations of GSK3206944 | 4 hours | 69.2315 Nanogram per milliliter |
Secondary
Part A: Plasma Concentrations of GSK3358699
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. Pharmacokinetic (PK) parameters were calculated using standard non-compartmental analysis. PK Population consisted of all participants in the Safety Population who received an active dose and for whom a PK sample was obtained and analyzed.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period
Population: PK 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 (MEDIAN) |
|---|---|---|---|
| Part A: Placebo SD | Part A: Plasma Concentrations of GSK3358699 | 12 hours, n=5,3,2,6,12,6,6 | NA Nanogram per milliliter |
| Part A: Placebo SD | Part A: Plasma Concentrations of GSK3358699 | 24 hours, n=5,3,6,6,9,4,5 | NA Nanogram per milliliter |
| Part A: Placebo SD | Part A: Plasma Concentrations of GSK3358699 | 1 hour, n=5,3,6,6,12,6,6 | 0.4210 Nanogram per milliliter |
| Part A: Placebo SD | Part A: Plasma Concentrations of GSK3358699 | 2 hours, n=5,3,6,6,12,6,6 | 0.1810 Nanogram per milliliter |
| Part A: Placebo SD | Part A: Plasma Concentrations of GSK3358699 | 8 hours, n=5,3,6,6,12,6,6 | NA Nanogram per milliliter |
| Part A: Placebo SD | Part A: Plasma Concentrations of GSK3358699 | 30 minutes, n=5,3,6,6,12,6,6 | 0.6840 Nanogram per milliliter |
| Part A: Placebo SD | Part A: Plasma Concentrations of GSK3358699 | 4 hours, n=5,2,6,6,12,6,6 | NA Nanogram per milliliter |
| Part A: Placebo SD | Part A: Plasma Concentrations of GSK3358699 | 15 minutes, n=5,3,6,6,12,6,6 | 0.4950 Nanogram per milliliter |
| Part A: Placebo SD | Part A: Plasma Concentrations of GSK3358699 | 6 hours, n=5,3,6,6,12,6,6 | NA Nanogram per milliliter |
| Part A: Placebo SD | Part A: Plasma Concentrations of GSK3358699 | Pre-dose, n=5,3,6,6,12,6,6 | 0.0000 Nanogram per milliliter |
| Part A: Placebo SD | Part A: Plasma Concentrations of GSK3358699 | 48 hours, n=5,3,6,6,6,6,6 | NA Nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Plasma Concentrations of GSK3358699 | 2 hours, n=5,3,6,6,12,6,6 | 0.4790 Nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Plasma Concentrations of GSK3358699 | Pre-dose, n=5,3,6,6,12,6,6 | 0.0000 Nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Plasma Concentrations of GSK3358699 | 15 minutes, n=5,3,6,6,12,6,6 | 0.6470 Nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Plasma Concentrations of GSK3358699 | 4 hours, n=5,2,6,6,12,6,6 | 0.1560 Nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Plasma Concentrations of GSK3358699 | 8 hours, n=5,3,6,6,12,6,6 | NA Nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Plasma Concentrations of GSK3358699 | 48 hours, n=5,3,6,6,6,6,6 | NA Nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Plasma Concentrations of GSK3358699 | 6 hours, n=5,3,6,6,12,6,6 | NA Nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Plasma Concentrations of GSK3358699 | 12 hours, n=5,3,2,6,12,6,6 | NA Nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Plasma Concentrations of GSK3358699 | 1 hour, n=5,3,6,6,12,6,6 | 0.9960 Nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Plasma Concentrations of GSK3358699 | 24 hours, n=5,3,6,6,9,4,5 | NA Nanogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part A: Plasma Concentrations of GSK3358699 | 30 minutes, n=5,3,6,6,12,6,6 | 1.9510 Nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Plasma Concentrations of GSK3358699 | 1 hour, n=5,3,6,6,12,6,6 | 3.5150 Nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Plasma Concentrations of GSK3358699 | 30 minutes, n=5,3,6,6,12,6,6 | 6.4560 Nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Plasma Concentrations of GSK3358699 | 24 hours, n=5,3,6,6,9,4,5 | NA Nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Plasma Concentrations of GSK3358699 | 15 minutes, n=5,3,6,6,12,6,6 | 1.0480 Nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Plasma Concentrations of GSK3358699 | 12 hours, n=5,3,2,6,12,6,6 | 0.1390 Nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Plasma Concentrations of GSK3358699 | 8 hours, n=5,3,6,6,12,6,6 | 0.2120 Nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Plasma Concentrations of GSK3358699 | 2 hours, n=5,3,6,6,12,6,6 | 1.6930 Nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Plasma Concentrations of GSK3358699 | 4 hours, n=5,2,6,6,12,6,6 | 0.5265 Nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Plasma Concentrations of GSK3358699 | Pre-dose, n=5,3,6,6,12,6,6 | 0.0000 Nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Plasma Concentrations of GSK3358699 | 48 hours, n=5,3,6,6,6,6,6 | NA Nanogram per milliliter |
| Part A: GSK3358699 3 mg SD | Part A: Plasma Concentrations of GSK3358699 | 6 hours, n=5,3,6,6,12,6,6 | 0.3160 Nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Plasma Concentrations of GSK3358699 | 8 hours, n=5,3,6,6,12,6,6 | 0.3775 Nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Plasma Concentrations of GSK3358699 | 1 hour, n=5,3,6,6,12,6,6 | 9.1840 Nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Plasma Concentrations of GSK3358699 | 2 hours, n=5,3,6,6,12,6,6 | 4.8100 Nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Plasma Concentrations of GSK3358699 | 4 hours, n=5,2,6,6,12,6,6 | 1.2865 Nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Plasma Concentrations of GSK3358699 | 6 hours, n=5,3,6,6,12,6,6 | 0.6720 Nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Plasma Concentrations of GSK3358699 | 12 hours, n=5,3,2,6,12,6,6 | 0.1490 Nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Plasma Concentrations of GSK3358699 | 24 hours, n=5,3,6,6,9,4,5 | NA Nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Plasma Concentrations of GSK3358699 | 48 hours, n=5,3,6,6,6,6,6 | NA Nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Plasma Concentrations of GSK3358699 | Pre-dose, n=5,3,6,6,12,6,6 | 0.0000 Nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Plasma Concentrations of GSK3358699 | 15 minutes, n=5,3,6,6,12,6,6 | 0.5390 Nanogram per milliliter |
| Part A: GSK3358699 10 mg SD | Part A: Plasma Concentrations of GSK3358699 | 30 minutes, n=5,3,6,6,12,6,6 | 5.1050 Nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Plasma Concentrations of GSK3358699 | 24 hours, n=5,3,6,6,9,4,5 | 0.1510 Nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Plasma Concentrations of GSK3358699 | 8 hours, n=5,3,6,6,12,6,6 | 0.5915 Nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Plasma Concentrations of GSK3358699 | 4 hours, n=5,2,6,6,12,6,6 | 1.9095 Nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Plasma Concentrations of GSK3358699 | 48 hours, n=5,3,6,6,6,6,6 | 0.0000 Nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Plasma Concentrations of GSK3358699 | 6 hours, n=5,3,6,6,12,6,6 | 1.1020 Nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Plasma Concentrations of GSK3358699 | Pre-dose, n=5,3,6,6,12,6,6 | 0.0000 Nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Plasma Concentrations of GSK3358699 | 1 hour, n=5,3,6,6,12,6,6 | 11.0785 Nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Plasma Concentrations of GSK3358699 | 15 minutes, n=5,3,6,6,12,6,6 | 0.2620 Nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Plasma Concentrations of GSK3358699 | 2 hours, n=5,3,6,6,12,6,6 | 6.9495 Nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Plasma Concentrations of GSK3358699 | 12 hours, n=5,3,2,6,12,6,6 | 0.2510 Nanogram per milliliter |
| Part A: GSK3358699 20 mg SD | Part A: Plasma Concentrations of GSK3358699 | 30 minutes, n=5,3,6,6,12,6,6 | 5.9130 Nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Plasma Concentrations of GSK3358699 | 6 hours, n=5,3,6,6,12,6,6 | 1.4305 Nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Plasma Concentrations of GSK3358699 | 1 hour, n=5,3,6,6,12,6,6 | 28.4500 Nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Plasma Concentrations of GSK3358699 | 4 hours, n=5,2,6,6,12,6,6 | 3.6390 Nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Plasma Concentrations of GSK3358699 | Pre-dose, n=5,3,6,6,12,6,6 | 0.0000 Nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Plasma Concentrations of GSK3358699 | 2 hours, n=5,3,6,6,12,6,6 | 10.6550 Nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Plasma Concentrations of GSK3358699 | 12 hours, n=5,3,2,6,12,6,6 | 0.5195 Nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Plasma Concentrations of GSK3358699 | 15 minutes, n=5,3,6,6,12,6,6 | 5.8460 Nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Plasma Concentrations of GSK3358699 | 24 hours, n=5,3,6,6,9,4,5 | 0.1250 Nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Plasma Concentrations of GSK3358699 | 8 hours, n=5,3,6,6,12,6,6 | 0.8340 Nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Plasma Concentrations of GSK3358699 | 30 minutes, n=5,3,6,6,12,6,6 | 64.4810 Nanogram per milliliter |
| Part A: GSK3358699 25 mg SD | Part A: Plasma Concentrations of GSK3358699 | 48 hours, n=5,3,6,6,6,6,6 | NA Nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Plasma Concentrations of GSK3358699 | 48 hours, n=5,3,6,6,6,6,6 | NA Nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Plasma Concentrations of GSK3358699 | 1 hour, n=5,3,6,6,12,6,6 | 28.8380 Nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Plasma Concentrations of GSK3358699 | 30 minutes, n=5,3,6,6,12,6,6 | 33.2120 Nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Plasma Concentrations of GSK3358699 | 24 hours, n=5,3,6,6,9,4,5 | 0.2090 Nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Plasma Concentrations of GSK3358699 | 6 hours, n=5,3,6,6,12,6,6 | 1.2515 Nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Plasma Concentrations of GSK3358699 | Pre-dose, n=5,3,6,6,12,6,6 | 0.0000 Nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Plasma Concentrations of GSK3358699 | 4 hours, n=5,2,6,6,12,6,6 | 2.5920 Nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Plasma Concentrations of GSK3358699 | 2 hours, n=5,3,6,6,12,6,6 | 8.6735 Nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Plasma Concentrations of GSK3358699 | 15 minutes, n=5,3,6,6,12,6,6 | 0.9245 Nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Plasma Concentrations of GSK3358699 | 12 hours, n=5,3,2,6,12,6,6 | 0.4255 Nanogram per milliliter |
| Part A: GSK3358699 30 mg SD | Part A: Plasma Concentrations of GSK3358699 | 8 hours, n=5,3,6,6,12,6,6 | 0.6665 Nanogram per milliliter |
Secondary
Part A: t1/2 of GSK3206944
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period
Population: PK Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo SD | Part A: t1/2 of GSK3206944 | 4.97 Hours |
| Part A: GSK3358699 1 mg SD | Part A: t1/2 of GSK3206944 | 4.91 Hours |
| Part A: GSK3358699 3 mg SD | Part A: t1/2 of GSK3206944 | 4.10 Hours |
| Part A: GSK3358699 10 mg SD | Part A: t1/2 of GSK3206944 | 3.80 Hours |
| Part A: GSK3358699 20 mg SD | Part A: t1/2 of GSK3206944 | 7.81 Hours |
| Part A: GSK3358699 25 mg SD | Part A: t1/2 of GSK3206944 | 6.98 Hours |
| Part A: GSK3358699 30 mg SD | Part A: t1/2 of GSK3206944 | 6.76 Hours |
Secondary
Part A: Time to Cmax (Tmax) of GSK3358699
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period
Population: PK Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo SD | Part A: Time to Cmax (Tmax) of GSK3358699 | 0.50 Hours |
| Part A: GSK3358699 1 mg SD | Part A: Time to Cmax (Tmax) of GSK3358699 | 0.50 Hours |
| Part A: GSK3358699 3 mg SD | Part A: Time to Cmax (Tmax) of GSK3358699 | 0.50 Hours |
| Part A: GSK3358699 10 mg SD | Part A: Time to Cmax (Tmax) of GSK3358699 | 1.00 Hours |
| Part A: GSK3358699 20 mg SD | Part A: Time to Cmax (Tmax) of GSK3358699 | 1.00 Hours |
| Part A: GSK3358699 25 mg SD | Part A: Time to Cmax (Tmax) of GSK3358699 | 0.76 Hours |
| Part A: GSK3358699 30 mg SD | Part A: Time to Cmax (Tmax) of GSK3358699 | 0.51 Hours |
Secondary
Part A: Tmax of GSK3206944
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period
Population: PK Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo SD | Part A: Tmax of GSK3206944 | 1.00 Hours |
| Part A: GSK3358699 1 mg SD | Part A: Tmax of GSK3206944 | 2.00 Hours |
| Part A: GSK3358699 3 mg SD | Part A: Tmax of GSK3206944 | 2.00 Hours |
| Part A: GSK3358699 10 mg SD | Part A: Tmax of GSK3206944 | 2.01 Hours |
| Part A: GSK3358699 20 mg SD | Part A: Tmax of GSK3206944 | 2.00 Hours |
| Part A: GSK3358699 25 mg SD | Part A: Tmax of GSK3206944 | 2.00 Hours |
| Part A: GSK3358699 30 mg SD | Part A: Tmax of GSK3206944 | 2.00 Hours |
Secondary
Part B: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
Whole blood samples were planned to be collected in TruCulture tubes, containing LPS and incubated for 24 hours, post which the inflammatory mediators (MCP-1, IL6 and TNF alpha) were planned to be analyzed.
Time frame: Day 1: 1, 4, 8, 12, 24 and 48 hours
Population: Safety Population. Data was not collected as no participants were enrolled in Part B.
Secondary
Part B: AUC(0-24) of GSK3206944
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3206944. GSK3206944 is a metabolite of GSK3358699.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours post-dose in each treatment period
Population: PK Population. Data was not collected as no participants were enrolled in Part B.
Secondary
Part B: AUC(0-24) of GSK3358699
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3358699.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours post-dose in each treatment period
Population: PK Population. Data was not collected as no participants were enrolled in Part B.
Secondary
Part B: AUC(0-infinity) of GSK3206944
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3206944. GSK3206944 is a metabolite of GSK3358699.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period
Population: PK Population. Data was not collected as no participants were enrolled in Part B.
Secondary
Part B: AUC(0-infinity) of GSK3358699
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3358699.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period
Population: PK Population. Data was not collected as no participants were enrolled in Part B.
Secondary
Part B: AUC(0-t) of GSK3206944
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3206944. GSK3206944 is a metabolite of GSK3358699.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period
Population: PK Population. Data was not collected as no participants were enrolled in Part B.
Secondary
Part B: AUC(0-t) of GSK3358699
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3358699.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period
Population: PK Population. Data was not collected as no participants were enrolled in Part B.
Secondary
Part B: Cmax of GSK3206944
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3206944. GSK3206944 is a metabolite of GSK3358699.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period
Population: PK Population. Data was not collected as no participants were enrolled in Part B.
Secondary
Part B: Cmax of GSK3358699
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3358699.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period
Population: PK Population. Data was not collected as no participants were enrolled in Part B.
Secondary
Part B: Monocyte Intracellular Concentration of GSK3206944
Blood samples were planned to be collected into sodium heparin tubes for the isolation of monocytes and for measurement of GSK3206944 concentrations in monocytes. GSK3206944 is a metabolite of GSK3358699.
Time frame: Day 1: 1, 4, 8, 24 and 48 hours post-dose in each treatment period
Population: PK Population. Data was not collected as no participants were enrolled in Part B.
Secondary
Part B: Plasma Concentrations of GSK3206944
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3206944. GSK3206944 is a metabolite of GSK3358699.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period
Population: PK Population. Data was not collected as no participants were enrolled in Part B.
Secondary
Part B: Plasma Concentrations of GSK3358699
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3358699.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period
Population: PK Population. Data was not collected as no participants were enrolled in Part B.
Secondary
Part B: t1/2 of GSK3206944
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3206944. GSK3206944 is a metabolite of GSK3358699.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period
Population: PK Population. Data was not collected as no participants were enrolled in Part B.
Secondary
Part B: t1/2 of GSK3358699
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3358699.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period
Population: PK Population. Data was not collected as no participants were enrolled in Part B.
Secondary
Part B: Tmax of GSK3206944
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3206944. GSK3206944 is a metabolite of GSK3358699.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period
Population: PK Population. Data was not collected as no participants were enrolled in Part B.
Secondary
Part B: Tmax of GSK3358699
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3358699.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment period
Population: PK Population. Data was not collected as no participants were enrolled in Part B.
Secondary
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
Whole blood samples of 1 mL were collected in TruCulture tubes, containing LPS and incubated for 24 hours, post which the inflammatory mediators (MCP-1, IL-6 and TNF alpha) were analyzed.
Time frame: Day 1: 1, 4 and 8 hours; Days 2, 4, 8 and 12: Pre-dose; Day 13: Pre-dose, 1, 4 and 8 hours; Day 14: Pre-dose, Pre-LPS challenge, 1, 4, 8, 24 and 48 hours
Population: Safety Population. Data was not collected for Cohorts 6 to 8 as no participants were enrolled. 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 (MEDIAN) |
|---|---|---|---|
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 8,Pre-dose,n=6,7,0,0,0 | 11305.84 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 13,4 hours,n=1,1,0,0,0 | 1872.12 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 14,Pre LPS challenge,n=1,1,0,0,0 | 8696.65 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 13,8 hours,n=1,1,0,0,0 | 1997.87 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 1,8 hours,n=11,14,0,0,0 | 13079.21 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 14,Pre-dose,n=1,1,0,0,0 | 2007.09 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 14,1 hour,n=1,1,0,0,0 | 10082.23 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 14,Pre LPS challenge,n=1,1,0,0,0 | 1876.05 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 12,Pre-dose,n=5,4,0,0,0 | 9329.36 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 14,1 hour,n=1,1,0,0,0 | 3503.11 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 14,4 hours,n=1,1,0,0,0 | 9122.21 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 14,4 hours,n=1,1,0,0,0 | 2066.72 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 8,Pre-dose,n=6,7,0,0,0 | 2932.72 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 14,8 hours,n=1,1,0,0,0 | 2593.90 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 14,8 hours,n=1,1,0,0,0 | 10986.16 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 14,24 hours,n=1,1,0,0,0 | 2082.28 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 13,Pre-dose,n=1,1,0,0,0 | 9966.64 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 14,48 hours,n=1,1,0,0,0 | 1879.53 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 14,24 hours,n=1,1,0,0,0 | 9176.89 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 1,1 hour,n=11,13,0,0,0 | 1994.72 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 14,48 hours,n=1,1,0,0,0 | 8257.88 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 1,4 hours,n=11,14,0,0,0 | 1843.08 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 2,Pre-dose,n=11,14,0,0,0 | 9323.67 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 1,8 hours,n=11,14,0,0,0 | 3692.36 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 1,1 hour,n=11,14,0,0,0 | 1739.49 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 2,Pre-dose,n=11,14,0,0,0 | 2711.07 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 13,1 hour,n=1,1,0,0,0 | 11718.40 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 4,Pre-dose,n=11,14,0,0,0 | 2987.24 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 1,4 hours,n=11,14,0,0,0 | 1825.09 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 1,4 hours,n=11,14,0,0,0 | 9121.35 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 12,Pre-dose,n=5,4,0,0,0 | 2482.03 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 1,8 hours,n=11,14,0,0,0 | 2002.44 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 13,Pre-dose,n=1,1,0,0,0 | 2311.66 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 13,4 hours,n=1,1,0,0,0 | 7099.42 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 13,1 hour,n=1,1,0,0,0 | 3495.21 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 2,Pre-dose,n=11,14,0,0,0 | 1939.09 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 13,4 hours,n=1,1,0,0,0 | 1573.18 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 4,Pre-dose,n=11,14,0,0,0 | 1677.88 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 13,8 hours,n=1,1,0,0,0 | 2486.89 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 4,Pre-dose,n=11,14,0,0,0 | 11002.47 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 14,Pre-dose,n=1,1,0,0,0 | 2304.40 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 8,Pre-dose,n=6,7,0,0,0 | 1638.33 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 14,Pre LPS challenge,n=1,1,0,0,0 | 2092.07 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 13,8 hours,n=1,1,0,0,0 | 10722.24 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 14,1 hour,n=1,1,0,0,0 | 2103.62 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 12,Pre-dose,n=5,4,0,0,0 | 1799.12 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 14,4 hours,n=1,1,0,0,0 | 1771.69 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 1,1 hour,n=11,13,0,0,0 | 9488.65 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 14,8 hours,n=1,1,0,0,0 | 2560.84 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 13,Pre-dose,n=1,1,0,0,0 | 1839.00 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 14,24 hours,n=1,1,0,0,0 | 1482.94 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 14,Pre-dose,n=1,1,0,0,0 | 8918.96 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 14,48 hours,n=1,1,0,0,0 | 1909.65 Picogram per milliliter |
| Part A: Placebo SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 13,1 hour,n=1,1,0,0,0 | 2113.92 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 13,1 hour,n=1,1,0,0,0 | 294.72 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 14,24 hours,n=1,1,0,0,0 | 9114.15 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 1,1 hour,n=11,13,0,0,0 | 9629.75 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 1,4 hours,n=11,14,0,0,0 | 10686.75 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 1,8 hours,n=11,14,0,0,0 | 15475.58 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 2,Pre-dose,n=11,14,0,0,0 | 12396.71 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 4,Pre-dose,n=11,14,0,0,0 | 12558.78 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 8,Pre-dose,n=6,7,0,0,0 | 10766.02 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 12,Pre-dose,n=5,4,0,0,0 | 10539.82 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 13,Pre-dose,n=1,1,0,0,0 | 12743.26 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 13,1 hour,n=1,1,0,0,0 | 12508.94 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 13,4 hours,n=1,1,0,0,0 | 11616.53 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 13,8 hours,n=1,1,0,0,0 | 16723.58 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 14,Pre-dose,n=1,1,0,0,0 | 14654.83 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 14,Pre LPS challenge,n=1,1,0,0,0 | 11340.79 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 14,1 hour,n=1,1,0,0,0 | 13244.20 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 14,4 hours,n=1,1,0,0,0 | 11543.08 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 14,8 hours,n=1,1,0,0,0 | 12544.55 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | IL6:Day 14,48 hours,n=1,1,0,0,0 | 10304.01 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 1,1 hour,n=11,14,0,0,0 | 2216.06 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 1,4 hours,n=11,14,0,0,0 | 2405.11 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 1,8 hours,n=11,14,0,0,0 | 2044.64 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 4,Pre-dose,n=11,14,0,0,0 | 1939.65 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 8,Pre-dose,n=6,7,0,0,0 | 1719.26 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 12,Pre-dose,n=5,4,0,0,0 | 2176.12 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 13,Pre-dose,n=1,1,0,0,0 | 513.36 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 2,Pre-dose,n=11,14,0,0,0 | 1928.51 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 13,4 hours,n=1,1,0,0,0 | 890.77 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 13,8 hours,n=1,1,0,0,0 | 1412.52 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 14,Pre-dose,n=1,1,0,0,0 | 4935.03 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 14,Pre LPS challenge,n=1,1,0,0,0 | 1981.15 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 14,1 hour,n=1,1,0,0,0 | 3623.79 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 14,4 hours,n=1,1,0,0,0 | 3293.92 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 14,8 hours,n=1,1,0,0,0 | 3150.84 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 14,24 hours,n=1,1,0,0,0 | 3372.94 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | MCP-1:Day 14,48 hours,n=1,1,0,0,0 | 2715.94 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 1,1 hour,n=11,13,0,0,0 | 2078.66 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 1,4 hours,n=11,14,0,0,0 | 2297.36 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 1,8 hours,n=11,14,0,0,0 | 3854.86 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 2,Pre-dose,n=11,14,0,0,0 | 3028.33 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 4,Pre-dose,n=11,14,0,0,0 | 3045.05 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 8,Pre-dose,n=6,7,0,0,0 | 2849.52 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 12,Pre-dose,n=5,4,0,0,0 | 2407.60 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 13,Pre-dose,n=1,1,0,0,0 | 2995.36 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 13,1 hour,n=1,1,0,0,0 | 2648.27 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 13,4 hours,n=1,1,0,0,0 | 2815.39 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 13,8 hours,n=1,1,0,0,0 | 4472.25 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 14,Pre-dose,n=1,1,0,0,0 | 3327.69 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 14,Pre LPS challenge,n=1,1,0,0,0 | 2081.54 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 14,1 hour,n=1,1,0,0,0 | 3133.32 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 14,4 hours,n=1,1,0,0,0 | 2457.35 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 14,8 hours,n=1,1,0,0,0 | 3481.91 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 14,24 hours,n=1,1,0,0,0 | 2187.40 Picogram per milliliter |
| Part A: GSK3358699 1 mg SD | Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation | TNF alpha:Day 14,48 hours,n=1,1,0,0,0 | 2597.32 Picogram per milliliter |
Secondary
Part C: AUC(0-24) of GSK3206944
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699.
Time frame: Days 1 and 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, and 24 hours post-dose
Population: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Placebo SD | Part C: AUC(0-24) of GSK3206944 | Day 1, n=14,0,0,0 | 115.31 Hours*nanogram per milliliter |
| Part A: Placebo SD | Part C: AUC(0-24) of GSK3206944 | Day 14, n=2,0,0,0 | 106.19 Hours*nanogram per milliliter |
Secondary
Part C: AUC(0-24) of GSK3358699
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis.
Time frame: Days 1 and 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, and 24 hours post-dose
Population: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Placebo SD | Part C: AUC(0-24) of GSK3358699 | Day 1, n=7,0,0,0 | 9.07 Hours*nanogram per milliliter |
| Part A: Placebo SD | Part C: AUC(0-24) of GSK3358699 | Day 14, n=1,0,0,0 | 7.99 Hours*nanogram per milliliter |
Secondary
Part C: AUC(0-infinity) of GSK3206944
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose
Population: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Placebo SD | Part C: AUC(0-infinity) of GSK3206944 | Day 1, n=14,0,0,0 | 117.25 Hours*nanogram per milliliter |
Secondary
Part C: AUC(0-infinity) of GSK3358699
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose
Population: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Placebo SD | Part C: AUC(0-infinity) of GSK3358699 | Day 1, n=7,0,0,0 | 9.07 Hours*nanogram per milliliter |
Secondary
Part C: AUC(0-t) of GSK3206944
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose
Population: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Placebo SD | Part C: AUC(0-t) of GSK3206944 | Day 1, n=14,0,0,0 | 115.17 Hours*nanogram per milliliter |
| Part A: Placebo SD | Part C: AUC(0-t) of GSK3206944 | Day 14, n=2,0,0,0 | 109.71 Hours*nanogram per milliliter |
Secondary
Part C: AUC(0-t) of GSK3358699
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose
Population: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Placebo SD | Part C: AUC(0-t) of GSK3358699 | Day 1, n=14,0,0,0 | 9.47 Hours*nanogram per milliliter |
| Part A: Placebo SD | Part C: AUC(0-t) of GSK3358699 | Day 14, n=2,0,0,0 | 11.70 Hours*nanogram per milliliter |
Secondary
Part C: Cmax of GSK3206944
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose
Population: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Placebo SD | Part C: Cmax of GSK3206944 | Day 1, n=14,0,0,0 | 23.02 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Cmax of GSK3206944 | Day 14, n=2,0,0,0 | 15.34 Nanogram per milliliter |
Secondary
Part C: Cmax of GSK3358699
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose
Population: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Placebo SD | Part C: Cmax of GSK3358699 | Day 1, n=14,0,0,0 | 6.19 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Cmax of GSK3358699 | Day 14, n=2,0,0,0 | 6.01 Nanogram per milliliter |
Secondary
Part C: Monocyte Intracellular Concentration of GSK3206944
Blood samples were collected into sodium heparin tubes for the isolation of monocytes and for measurement of GSK3206944 concentrations in monocytes. GSK3206944 is a metabolite of GSK3358699.
Time frame: Days 1 and 13: 1, 4 and 8 hour; Days 4, 8 and 12: Pre-dose; Day 14: 1, 4, 8, 24 and 48 hours post-dose
Population: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Placebo SD | Part C: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 1 hour,n=14,0,0,0 | 0.313 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 4 hours,n=14,0,0,0 | NA Nanogram per milliliter |
| Part A: Placebo SD | Part C: Monocyte Intracellular Concentration of GSK3206944 | Day 1: 8 hours,n=14,0,0,0 | NA Nanogram per milliliter |
| Part A: Placebo SD | Part C: Monocyte Intracellular Concentration of GSK3206944 | Day 4: Pre-dose,n=14,0,0,0 | NA Nanogram per milliliter |
| Part A: Placebo SD | Part C: Monocyte Intracellular Concentration of GSK3206944 | Day 8: Pre-dose,n=14,0,0,0 | NA Nanogram per milliliter |
| Part A: Placebo SD | Part C: Monocyte Intracellular Concentration of GSK3206944 | Day 12: Pre-dose,n=14,0,0,0 | NA Nanogram per milliliter |
| Part A: Placebo SD | Part C: Monocyte Intracellular Concentration of GSK3206944 | Day 13: 1 hour,n=1,0,0,0 | 0.317 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Monocyte Intracellular Concentration of GSK3206944 | Day 13: 4 hours,n=1,0,0,0 | NA Nanogram per milliliter |
| Part A: Placebo SD | Part C: Monocyte Intracellular Concentration of GSK3206944 | Day 13: 8 hours,n=1,0,0,0 | NA Nanogram per milliliter |
| Part A: Placebo SD | Part C: Monocyte Intracellular Concentration of GSK3206944 | Day 14: 1 hour,n=1,0,0,0 | 0.256 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Monocyte Intracellular Concentration of GSK3206944 | Day 14: 4 hours,n=1,0,0,0 | NA Nanogram per milliliter |
| Part A: Placebo SD | Part C: Monocyte Intracellular Concentration of GSK3206944 | Day 14: 8 hours,n=1,0,0,0 | NA Nanogram per milliliter |
| Part A: Placebo SD | Part C: Monocyte Intracellular Concentration of GSK3206944 | Day 14: 24 hours,n=1,0,0,0 | NA Nanogram per milliliter |
| Part A: Placebo SD | Part C: Monocyte Intracellular Concentration of GSK3206944 | Day 14: 48 hours,n=1,0,0,0 | NA Nanogram per milliliter |
Secondary
Part C: Plasma Concentrations of GSK3206944
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Days 4, 8 and 12: Pre-dose; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose
Population: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3206944 | Day 1:15 minutes,n=14,0,0,0 | 0.0000 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3206944 | Day 1:30 minutes,n=14,0,0,0 | 3.1310 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3206944 | Day 1:Pre-dose,n=14,0,0,0 | 0.0000 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3206944 | Day 1:1 hour,n=14,0,0,0 | 19.9335 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3206944 | Day 1:2 hours,n=14,0,0,0 | 22.2250 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3206944 | Day 1:4 hours,n=14,0,0,0 | 12.7730 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3206944 | Day 1:6 hours,n=14,0,0,0 | 7.2920 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3206944 | Day 1:8 hours,n=14,0,0,0 | 4.3750 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3206944 | Day 1:12 hours,n=14,0,0,0 | 2.2070 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3206944 | Day 1:24 hours,n=14,0,0,0 | 0.3805 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3206944 | Day 4: Pre-dose,n=14,0,0,0 | 0.5355 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3206944 | Day 8: Pre-dose,n=7,0,0,0 | 0.6640 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3206944 | Day 12: Pre-dose,n=4,0,0,0 | 0.4945 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3206944 | Day 14:Pre-dose,n=2,0,0,0 | 0.5820 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3206944 | Day 14:15 minutes,n=2,0,0,0 | 0.7430 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3206944 | Day 14:30 minutes,n=2,0,0,0 | 6.4130 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3206944 | Day 14:1 hour,n=2,0,0,0 | 15.3355 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3206944 | Day 14:2 hours,n=2,0,0,0 | 15.0925 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3206944 | Day 14:4 hours,n=2,0,0,0 | 10.4550 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3206944 | Day 14:6 hours,n=2,0,0,0 | 6.8500 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3206944 | Day 14:8 hours,n=2,0,0,0 | 6.0330 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3206944 | Day 14:12 hours,n=2,0,0,0 | 2.2290 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3206944 | Day 14:24 hours,n=2,0,0,0 | 0.5275 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3206944 | Day 14:48 hours,n=1,0,0,0 | 0.1110 Nanogram per milliliter |
Secondary
Part C: Plasma Concentrations of GSK3358699
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Days 4, 8 and 12: Pre-dose; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose
Population: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3358699 | Day 14:1 hour,n=2,0,0,0 | 3.0170 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3358699 | Day 14:24 hours,n=2,0,0,0 | NA Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3358699 | Day 14:48 hours,n=2,0,0,0 | NA Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3358699 | Day 14:30 minutes,n=2,0,0,0 | 6.0065 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3358699 | Day 14:15 minutes,n=2,0,0,0 | 4.3390 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3358699 | Day 1:Pre-dose,n=14,0,0,0 | 0.0000 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3358699 | Day 1:15 minutes,n=14,0,0,0 | 0.2825 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3358699 | Day 1:30 minutes,n=14,0,0,0 | 5.7430 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3358699 | Day 1:1 hour,n=14,0,0,0 | 3.8955 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3358699 | Day 1:2 hours,n=14,0,0,0 | 1.3365 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3358699 | Day 1:4 hours,n=14,0,0,0 | 0.5730 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3358699 | Day 1:6 hours,n=14,0,0,0 | 0.2940 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3358699 | Day 1:8 hours,n=10,0,0,0 | 0.1690 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3358699 | Day 1:12 hours,n=3,0,0,0 | 0.1390 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3358699 | Day 1:24 hours,n=14,0,0,0 | NA Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3358699 | Day 4: Pre-dose,n=1,0,0,0 | 0.0000 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3358699 | Day 8: Pre-dose,n=2,0,0,0 | 0.0000 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3358699 | Day 12: Pre-dose,n=4,0,0,0 | NA Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3358699 | Day 14:Pre-dose,n=2,0,0,0 | NA Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3358699 | Day 14:2 hours,n=2,0,0,0 | 1.4905 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3358699 | Day 14:4 hours,n=2,0,0,0 | 0.8295 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3358699 | Day 14:6 hours,n=2,0,0,0 | 0.6360 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3358699 | Day 14:8 hours,n=2,0,0,0 | 0.3920 Nanogram per milliliter |
| Part A: Placebo SD | Part C: Plasma Concentrations of GSK3358699 | Day 14:12 hours,n=1,0,0,0 | 0.2730 Nanogram per milliliter |
Secondary
Part C: t1/2 of GSK3206944
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose
Population: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Placebo SD | Part C: t1/2 of GSK3206944 | Day 1, n=14,0,0,0 | 5.02 Hours |
| Part A: Placebo SD | Part C: t1/2 of GSK3206944 | Day 14, n=2,0,0,0 | 6.15 Hours |
Secondary
Part C: t1/2 of GSK3358699
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose
Population: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Placebo SD | Part C: t1/2 of GSK3358699 | Day 1, n=7,0,0,0 | 2.47 Hours |
| Part A: Placebo SD | Part C: t1/2 of GSK3358699 | Day 14, n=1,0,0,0 | 1.57 Hours |
Secondary
Part C: Tmax of GSK3206944
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose
Population: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Placebo SD | Part C: Tmax of GSK3206944 | Day 1, n=14,0,0,0 | 2.00 Hours |
| Part A: Placebo SD | Part C: Tmax of GSK3206944 | Day 14, n=2,0,0,0 | 0.99 Hours |
Secondary
Part C: Tmax of GSK3358699
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis.
Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose
Population: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Placebo SD | Part C: Tmax of GSK3358699 | Day 1, n=14,0,0,0 | 0.50 Hours |
| Part A: Placebo SD | Part C: Tmax of GSK3358699 | Day 14, n=2,0,0,0 | 0.53 Hours |