Muscular Dystrophies
Conditions
Keywords
Dose proportionality, Food effect, Pharmacokinetics, FTIH, Pharmacodynamics, Dose Escalation
Brief summary
The FTIH study with GSK3439171A will evaluate the safety of GSK3439171A in healthy subjects in order to avoid confounding factors due to the disease or concomitant drugs in patients. The study design is based on pre-clinical findings for GSK3439171A, contributing to the frequency, type and duration of safety assessment and monitoring during treatment periods in each cohort. The single dose assessments in Part A will be conducted to determine safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of the study intervention in individuals before progressing to doses explored further in other parts of the study and will allow for any adjustments needed based on emerging safety, tolerability, and PK information. Part A will also serve to identify a dose for use in examining the effect of food on GSK3439171A exposure in Part C. In Part B, a single dose safety, tolerability and PK will be collected followed by progression of these subjects to the repeat dose portion of the study. The up to 14-day dosing was chosen as it is thought to provide sufficient safety and tolerability data to bridge to longer duration studies. The dosing period can be adjusted depending on PK and PD data collected in Part A of the study. Part B will involve more detailed PK/PD/metabolite assessments to better understand the impact of GSK3439171A on target engagement and metabolism in humans. Approximately 150 subjects will be screened to achieve 75 randomly assigned to study intervention. Duration for Part A, B and C will be approximately 10 weeks, 9 weeks and 8 weeks respectively.
Interventions
DRUGGSK3439171A
Oral solution with doses 0.5 mg up to 4.5 mg and capsule for doses 5 mg and upwards
DRUGPlacebo
Placebo oral solution to match with doses 0.5 mg up to 4.5 mg and capsule for doses 5 mg and upwards
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Part A is a Crossover group single ascending dose study with 2 arms per cohort that is subject and investigator blinded. Part B is a Parallel group repeat dose study with 2 arms per cohort that is subject and investigator blinded. Part C is a Crossover group food effect study with 2 arms per cohort that is not-masked.
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject must be 18 to 65 years of age inclusive, at the time of signing the informed consent. * Subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. A subject with a clinical abnormality or laboratory parameter(s) not specifically listed in the exclusion or
Exclusion criteria
that is outside the reference range for the population being studied may be included only if the investigator, in consultation with the Medical Monitor, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. * Subjects with Body weight \>=50.0 kilograms (Kg) (110 lbs.) and body mass index (BMI) within the range 18.5 to 31.0 kilograms per square meter (inclusive). * Only male subjects are eligible for this study. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Male subjects are eligible to participate if they agree to the following during the their entire enrolment in the study plus an additional 5 days or 5 terminal half-lives (whichever is longer): Refrain from donating sperm plus either be abstinent from sexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent or must agree to use contraception/barrier (female partner to use an additional highly effective contraceptive method with a failure rate of \<1% per year) * Subjects must be capable of giving signed informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| T1/2 of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 40 mg Only) | Day 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| AUC(0 to Inf) of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg) | Day 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| AUC(0 to Inf) of GSK3439171A Following Single Dose-Part B (GSK3439171A 40 mg Only) | Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| AUC(0 to Inf) of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 40 mg Only) | Day 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| Maximum Observed Plasma Concentration (Cmax) of GSK3439171A Following Single Dose-Part A (GSK3439171A 5 mg Only) | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| Cmax of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| Cmax of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg) | Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| Cmax of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg) | Day 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| Cmax of GSK3439171A Following Single Dose-Part B (GSK3439171A 40 mg Only) | Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| Cmax of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 40 mg Only) | Day 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| Time to Maximum Observed Plasma Concentration (Tmax) of GSK3439171A Following Single Dose-Part A (GSK3439171A 5 mg Only) | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| Tmax of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| Tmax of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg) | Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| Tmax of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg) | Day 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| Tmax of GSK3439171A Following Single Dose-Part B (GSK3439171A 40 mg Only) | Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| Tmax of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 40 mg Only) | Day 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| Apparent Terminal Half-life (T1/2) of GSK3439171A Following Single Dose-Part A (GSK3439171A 5 mg Only) | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| T1/2 of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| T1/2 of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg) | Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| T1/2 of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg) | Day 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| T1/2 of GSK3439171A Following Single Dose-Part B (GSK3439171A 40 mg Only) | Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part A | Up to Day 40 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. |
| Number of Participants With AEs and SAEs-Part B | Up to Day 34 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. |
| Number of Participants With AEs and SAEs-Part C | Up to Day 29 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. |
| Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance-Part A | Up to Day 40 | Blood samples were collected for the assessment of clinical chemistry parameters. The clinical concern range for the parameters were: albumin (low: \<30 grams per liter \[g/L\]); alanine aminotransferase (ALT) (high: \>=2xupper limit of normal \[ULN\]); aspartate aminotransferase (AST) (high: \>=2xULN); alkaline phosphatase (ALP) (high: \>=2xULN); total bilirubin (high: \>=1.5xULN); calcium (low: \<2 millimoles (mmol)/L and high: \>2.75 mmol/L); creatinine (high: change from Baseline \>44.2 micromoles/L); glucose (low: \<3 mmol/L and high: \>9 mmol/L); magnesium (low: 0.5 mmol/L and high: 1.23 mmol/L); phosphorus (low: 0.8 mmol/L and high: 1.6 mmol/L); potassium (low: \<3 mmol/L and high: \>5.5 mmol/L); sodium (low: \<130 mmol/L and high: \>150 mmol/L) and creatine kinase (high: \>500 units per liter). The number of participants with any clinical chemistry abnormality of potential clinical importance is reported. |
| Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance-Part B | Up to Day 34 | Blood samples were collected for the assessment of clinical chemistry parameters. The clinical concern range for the parameters were: albumin (low: \<30 g/L); ALT (high: \>=2xULN); AST (high: \>=2xULN); ALP (high: \>=2xULN); total bilirubin (high: \>=1.5xULN); calcium (low: \<2 mmol/L and high: \>2.75 mmol/L); creatinine (high: change from Baseline \>44.2 micromoles/L); glucose (low: \<3 mmol/L and high: \>9 mmol/L); magnesium (low: 0.5 mmol/L and high: 1.23 mmol/L); phosphorus (low: 0.8 mmol/L and high: 1.6 mmol/L); potassium (low: \<3 mmol/L and high: \>5.5 mmol/L); sodium (low: \<130 mmol/L and high: \>150 mmol/L) and creatine kinase (high: \>500 units per liter). The number of participants with any clinical chemistry abnormality of potential clinical importance is reported. |
| Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance-Part C | Up to Day 29 | Blood samples were collected for the assessment of clinical chemistry parameters. The clinical concern range for the parameters were: albumin (low: \<30 g/L); ALT (high: \>=2xULN); AST (high: \>=2xULN); ALP (high: \>=2xULN); total bilirubin (high: \>=1.5xULN); calcium (low: \<2 mmol/L and high: \>2.75 mmol/L); creatinine (high: change from Baseline \>44.2 micromoles/L); glucose (low: \<3 mmol/L and high: \>9 mmol/L); magnesium (low: 0.5 mmol/L and high: 1.23 mmol/L); phosphorus (low: 0.8 mmol/L and high: 1.6 mmol/L); potassium (low: \<3 mmol/L and high: \>5.5 mmol/L); sodium (low: \<130 mmol/L and high: \>150 mmol/L) and creatine kinase (high: \>500 units per liter). The number of participants with any clinical chemistry abnormality of potential clinical importance is reported. |
| Number of Participants With Hematology Abnormalities of Potential Clinical Importance-Part A | Up to Day 40 | Blood samples were collected for the assessment of hematology parameters. The clinical concern range for the parameters were: hematocrit (high: \>0.54 proportion of red blood cells in blood); hemoglobin (high: \>180 g/L), lymphocytes (low: \<0.8x10\^9 cells per liter \[cells/L\]); neutrophil count (low: \<1.5x10\^9 cells/L); platelet count (low: \<100x10\^9 cells/L and high: \>550x10\^9 cells/L); white blood cells count (low: \<3x10\^9 cells/L and high: \>20x10\^9 cells/L). The number of participants with any hematology abnormality of potential clinical importance is reported. |
| Number of Participants With Hematology Abnormalities of Potential Clinical Importance-Part B | Up to Day 34 | Blood samples were collected for the assessment of hematology parameters. The clinical concern range for the parameters were: hematocrit (high: \>0.54 proportion of red blood cells in blood); hemoglobin (high: \>180 g/L), lymphocytes (low: \<0.8x10\^9 cells/L); neutrophil count (low: \<1.5x10\^9 cells/L); platelet count (low: \<100x10\^9 cells/L and high: \>550x10\^9 cells/L); white blood cells count (low: \<3x10\^9 cells/L and high: \>20x10\^9 cells/L). The number of participants with any hematology abnormality of potential clinical importance is reported. |
| Number of Participants With Hematology Abnormalities of Potential Clinical Importance-Part C | Up to Day 29 | Blood samples were collected for the assessment of hematology parameters. The clinical concern range for the parameters were: hematocrit (high: \>0.54 proportion of red blood cells in blood); hemoglobin (high: \>180 g/L), lymphocytes (low: \<0.8x10\^9 cells/L); neutrophil count (low: \<1.5x10\^9 cells/L); platelet count (low: \<100x10\^9 cells/L and high: \>550x10\^9 cells/L); white blood cells count (low: \<3x10\^9 cells/L and high: \>20x10\^9 cells/L). The number of participants with any hematology abnormality of potential clinical importance is reported. |
| Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | 8 hours, 24 hours, 48 hours and 72 hours in Periods 1, 2 and 3 | Urine samples were taken for the assessment of following urine parameters: glucose, ketones, occult blood (OB) and protein by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+ indicating proportional concentrations in the urine sample. |
| Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | 8 hours, 24 hours, 48 hours and 72 hours in Periods 1, 2 and 3 | Urine samples were taken for the assessment of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 to 6.0). Dipstick test results for pH were presented as number of participants having pH value as 5, 6, 7, 8 or 9. |
| Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Day 2 (24 hours); Day 3 (48 hours); Days 4, 13 and 20 (72 hours); pre-dose on Days 7, 10, 11 and 17 | Urine samples were taken for the assessment of following urine parameters: glucose, ketones, OB and protein by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+ indicating proportional concentrations in the urine sample. |
| Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day 2 (24 hours); Day 3 (48 hours); Days 4, 13 and 20 (72 hours); pre-dose on Days 7, 10, 11 and 17 | Urine samples were taken for the assessment of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 to 6.0). Dipstick test results for pH were presented as number of participants having pH value as 5, 6, 7, 8 or 9. |
| Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | 8 hours, 24 hours, 48 hours and 72 hours in Period 1 and Period 2 | Urine samples were taken for the assessment of following urine parameters: glucose, ketones, OB and protein by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+ indicating proportional concentrations in the urine sample. |
| Number of Participants With Urinalysis Dipstick Results (pH)-Part C | 8 hours, 24 hours, 48 hours and 72 hours in Period 1 and Period 2 | Urine samples were taken for the assessment of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 to 6.0). Dipstick test results for pH were presented as number of participants having pH value as 5, 6, 7, 8 or 9. |
| Number of Participants With Vital Signs of Potential Clinical Importance-Part A | Up to Day 40 | Vital signs were measured in a supine position after five minutes of rest and included temperature, systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate and respiratory rate. The clinical concern range for the parameters included: SBP (low: \<85 millimeters of mercury \[mmHg\] and high: \>160 mmHg), DBP (low: \<45 mmHg and high: \>100 mmHg) and heart rate (low: \<40 beats per minute \[bpm\] and high: \>110 bpm). Number of participants with any vital signs of potential clinical importance is reported. |
| Number of Participants With Vital Signs of Potential Clinical Importance-Part B | Up to Day 34 | Vital signs were measured in a supine position after five minutes of rest and included temperature, SBP, DBP, heart rate and respiratory rate. The clinical concern range for the parameters included: SBP (low: \<85 mmHg and high: \>160 mmHg), DBP (low: \<45 mmHg and high: \>100 mmHg) and heart rate (low: \<40 bpm and high: \>110 bpm). Number of participants with any vital signs of potential clinical importance is reported. |
| Number of Participants With Vital Signs of Potential Clinical Importance-Part C | Up to Day 29 | Vital signs were measured in a supine position after five minutes of rest and included temperature, SBP, DBP, heart rate and respiratory rate. The clinical concern range for the parameters included: SBP (low: \<85 mmHg and high: \>160 mmHg), DBP (low: \<45 mmHg and high: \>100 mmHg) and heart rate (low: \<40 bpm and high: \>110 bpm). Number of participants with any vital signs of potential clinical importance is reported. |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Part A | Up to Day 40 | Twelve-lead ECGs were recorded with the participants in a supine position using an ECG machine that automatically calculated heart rate and measured PR, QRS, QT and corrected QT (QTc) intervals. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented. CS 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 worst case post-Baseline is presented. Baseline value is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Number of Participants With Abnormal ECG Findings-Part B | Up to Day 34 | Twelve-lead ECGs were recorded with the participants in a supine position using an ECG machine that automatically calculated heart rate and measured PR, QRS, QT and QTc intervals. CS and NCS abnormal ECG findings have been presented. CS 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 worst case post-Baseline is presented. Baseline value is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Number of Participants With Abnormal ECG Findings-Part C | Up to Day 29 | Twelve-lead ECGs were recorded with the participants in a supine position using an ECG machine that automatically calculated heart rate and measured PR, QRS, QT and QTc intervals. CS and NCS abnormal ECG findings have been presented. CS 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 worst case post-Baseline is presented. Baseline value is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Area Under Tha Plasma Drug Concentration Versus Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC[0 to t]) of GSK3439171A Following Single Dose-Part A (GSK3439171A 5 mg Only) | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| AUC(0 to t) of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| AUC(0 to t) of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg) | Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| AUC(0 to t) of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg) | Day 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| AUC(0 to t) of GSK3439171A Following Single Dose-Part B (GSK3439171A 40 mg Only) | Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| AUC(0 to t) of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 40 mg Only) | Day 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0 to Inf]) of GSK3439171A Following Single Dose-Part A (GSK3439171A 5 mg Only) | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| AUC(0 to Inf) of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| AUC(0 to Inf) of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg) | Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC(0 to Inf) of GSK3439171A (Food Effect)-Part C | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| Cmax for GSK3439171A (Food Effect)-Part C | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| Tmax for GSK3439171A-Part C | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| T1/2 for GSK3439171A-Part C | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| Dose Proportionality of GSK3439171A Using AUC(0 to t) Following a Single Dose-Part A | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Dose proportionality was assessed using Power model with fixed effects of logarithm of treatment and participant as random effect. Slope and 90% confidence interval for the slope are presented. |
| Dose Proportionality of GSK3439171A Using AUC(0 to Inf) Following a Single Dose-Part A | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Dose proportionality was assessed using Power model with fixed effects of logarithm of treatment and participant as random effect. Slope and 90 % confidence interval for the slope are presented. |
| Dose Proportionality of GSK3439171A Using Cmax Following a Single Dose-Part A | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Dose proportionality was assessed using Power model with fixed effects of logarithm of treatment and participant as random effect. Slope and 90% confidence interval for the slope are presented. |
| Dose Proportionality of GSK3439171A Using AUC(0 to Tau) Following Repeat Dose-Part B | Days 10 and 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Dose proportionality was assessed using Power model with fixed effects of logarithm of treatment and participant as random effect. Slope and 90% confidence interval for the slope are presented. |
| Dose Proportionality of GSK3439171A Using Cmax Following Repeat Dose-Part B | Days 10 and 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Dose proportionality was assessed using Power model with fixed effects of logarithm of treatment and participant as random effect. Slope and 90% confidence interval for the slope are presented. |
| Observed Accumulation Ratio for AUC (AUC[Ro])-Part B (GSK3439171A 5 mg and 11 mg) | Days 1 and 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. AUC(Ro) was calculated as Day17 AUC(0 to tau) divided by Day 1 AUC (0 to tau). Analysis was performed using Mixed effect model with AUC (0 to tau) as the response variable. Treatment, visit and treatment-by-visit interaction are added as fixed effects and participant as random effect. Ratio and 90% confidence interval of the ratio is presented. |
| Observed Accumulation Ratio for AUC (AUC[Ro])-Part B (GSK3439171A 40 mg Only) | Days 1 and 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. AUC(Ro) was calculated as Day10 AUC(0 to tau) divided by Day 1 AUC (0 to tau). Analysis was performed using Mixed effect model with AUC (0 to tau) as the response variable. Treatment, visit and treatment-by-visit interaction are added as fixed effects and participant as random effect. Ratio and 90% confidence interval of the ratio is presented. |
| Observed Accumulation Ratio for Cmax (RCmax)-Part B (GSK3439171A 5 mg and 11 mg) | Days 1 and 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. RCmax was calculated as Day17 Cmax divided by Day 1 Cmax. Analysis was performed using Mixed effect model with Cmax as the response variable. Treatment, visit and treatment-by-visit interaction are added as fixed effects and participant as random effect. Ratio and 90% confidence interval of the ratio is presented. |
| Observed Accumulation Ratio for Cmax (RCmax)-Part B (GSK3439171A 40 mg Only) | Days 1 and 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. RCmax was calculated as Day10 Cmax divided by Day 1 Cmax. Analysis was performed using Mixed effect model with Cmax as the response variable. Treatment, visit and treatment-by-visit interaction are added as fixed effects and participant as random effect. Ratio and 90% confidence interval of the ratio is presented. |
| Steady State Accumulation Ratio (Rss)-Part B (GSK3439171A 5 mg and 11 mg) | Days 1 and 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Rss was calculated as Day 17 AUC(0-tau) divided by Day 1 AUC(0-inf). Analysis was performed using Mixed Effect Model, with AUC(0-tau) and AUC(0-inf) as the response variables. Treatment, visit, parameter and parameter-by-treatment-by-visit interaction are added as fixed effects and participant as random effect. Ratio and 90% confidence interval of the ratio is presented. |
| Steady State Accumulation Ratio (Rss)-Part B (GSK3439171A 40 mg Only) | Days 1 and 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Rss was calculated as Day 10 AUC(0-tau) divided by Day 1 AUC(0-inf). Analysis was performed using Mixed Effect Model, with AUC(0-tau) and AUC(0-inf) as the response variables. Treatment, visit, parameter and parameter-by-treatment-by-visit interaction are added as fixed effects and participant as random effect. Ratio and 90% confidence interval of the ratio is presented. |
| Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9, 10, 11, 15, 16 and 17-Part B (GSK3439171A 5 mg and 11 mg) | pre-dose on Days 6, 7, 9, 10, 11, 15, 16 and 17 | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9 and 10-Part B (GSK3439171A 40 mg Only) | pre-dose on Days 6, 7, 9 and 10 | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
| Steady State Assessment Using Trough Plasma Concentration at the End of Dosing Interval for Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg) | pre-dose on Days 6, 7, 9, 10, 11, 15, 16 and 17 | Blood samples were collected at indicated time points for pharmacokinetic analysis. The slope estimate of the day effect was obtained from Mixed Effect Model, with visit as the fixed effect and participant as random effect. The analysis was done separately for each treatment. Variance Component covariance structure was used. The back transformed slope and 90% confidence interval for the slope is presented. |
| Steady State Assessment Using Trough Plasma Concentration at the End of Dosing Interval for Repeat Dose-Part B (GSK3439171A 40 mg Only) | pre-dose on Days 6, 7, 9 and 10 | Blood samples were collected at indicated time points for pharmacokinetic analysis. The slope estimate of the day effect was obtained from Mixed Effect Model, with visit as the fixed effect and participant as random effect. The analysis was done separately for each treatment. Variance Component covariance structure is used. The back transformed slope and 90% confidence interval for the slope is presented. |
| AUC(0 to t) of GSK3439171A (Food Effect)-Part C | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. |
Countries
United States
Participant flow
Recruitment details
This was a 3 part study conducted at a single center in the United States where, Part A is a single oral dose, dose-rising, 3 period crossover study; Part B is a repeat oral dosing, dose escalation study and Part C is a crossover study where a single dose was administered in fasted or fed conditions.
Pre-assignment details
A total of 66 participants were enrolled in Part A (18 participants), Part B (36 participants) and Part C (12 participants).
Participants by arm
| Arm | Count |
|---|---|
| GSK3439171A 5 mg/Placebo/GSK3439171A 30 mg Participants were administered a single oral dose of 5 milligrams (mg) GSK3439171A on Day 1 of treatment period 1, followed by a single oral dose of placebo on Day 1 of treatment period 2. Participants were further administered a single oral dose of 30 mg GSK3439171A on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment. | 3 |
| Placebo/ GSK3439171A 10 mg/GSK3439171A 30 mg Participants were administered a single oral dose of placebo on Day 1 of treatment period 1 followed by a single oral dose of 10 mg GSK3439171A on Day 1 of treatment period 2. Participants were further administered a single oral dose of 30 mg GSK3439171A in treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment. | 3 |
| GSK3439171A 5 mg/GSK3439171A 10 mg/Placebo Participants were administered a single oral dose of 5 mg GSK3439171A on Day 1 of treatment period 1 followed by a single oral dose of 10 mg GSK3439171A on Day 1 of treatment period 2. Participants were further administered a single oral dose of placebo on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment. | 3 |
| GSK3439171A 60 mg/GSK3439171A 120 mg/Placebo Participants were administered a single oral dose of 60 mg GSK3439171A on Day 1 of treatment period 1 followed by a single oral dose of 120 mg GSK3439171A on Day 1 of treatment period 2. Participants then administered a single oral dose of placebo on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment. | 3 |
| Placebo/ GSK3439171A 120 mg/GSK3439171A 180 mg Participants were administered a single oral dose of placebo on Day 1 of treatment period 1 followed by a single oral dose of 120 mg GSK3439171A on Day 1 of treatment period 2. Participants were further administered a single oral dose of 180 mg GSK3439171A on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment. | 3 |
| GSK3439171A 60 mg/Placebo/GSK3439171A 180 mg Participants were administered a single oral dose of 60 mg GSK3439171A on Day 1 of treatment period 1 followed by a single oral dose of placebo on Day 1 of treatment period 2. Participants were further administered a single oral dose of 180 mg GSK3439171A on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment. | 3 |
| Placebo Participants were administered placebo once daily via oral route for 13 or 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | 9 |
| GSK3439171A 5 mg Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | 9 |
| GSK3439171A 11 mg Participants were administered GSK343917A 11 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | 9 |
| GSK3439171A 40 mg Participants were administered GSK343917A 40 mg once daily via oral route for 13 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | 9 |
| GSK3439171A 60 mg Fasted/GSK3439171A 60 mg Fed Participants were administered a single oral dose of GSK3439171A 60 mg in the fasted state on Day 1 of treatment period 1 followed by a washout of 7 days. In treatment period 2, participants were administered a single oral dose of GSK3439171A 60 mg after a high fat meal. All participants were followed up for 14 days after the administration of last dose of study treatment. | 6 |
| GSK3439171A 60 mg Fed/GSK3439171A 60 mg Fasted Participants were administered a single oral dose of GSK3439171A 60 mg after a high fat meal on Day 1 of treatment period 1 followed by a washout of 7 days. In treatment period 2, participants were administered a single oral dose of GSK3439171A 60 mg in the fasted state. All participants were followed up for 14 days after the administration of last dose of study treatment. | 6 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A Washout 2 (7 Days) | Adverse Event | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part B (Maximum of 34 Days) | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
| Part C Washout 1 (7 Days) | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | GSK3439171A 5 mg/Placebo/GSK3439171A 30 mg | Placebo/ GSK3439171A 10 mg/GSK3439171A 30 mg | GSK3439171A 5 mg/GSK3439171A 10 mg/Placebo | GSK3439171A 60 mg/GSK3439171A 120 mg/Placebo | Placebo/ GSK3439171A 120 mg/GSK3439171A 180 mg | GSK3439171A 60 mg/Placebo/GSK3439171A 180 mg | Placebo | GSK3439171A 5 mg | GSK3439171A 11 mg | GSK3439171A 40 mg | GSK3439171A 60 mg Fasted/GSK3439171A 60 mg Fed | GSK3439171A 60 mg Fed/GSK3439171A 60 mg Fasted | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 39.0 Years STANDARD_DEVIATION 4.58 | 43.0 Years STANDARD_DEVIATION 2.65 | 37.3 Years STANDARD_DEVIATION 11.85 | 44.3 Years STANDARD_DEVIATION 12.5 | 49.0 Years STANDARD_DEVIATION 9.17 | 42.0 Years STANDARD_DEVIATION 7.55 | 46.7 Years STANDARD_DEVIATION 8.83 | 37.6 Years STANDARD_DEVIATION 9.26 | 45.0 Years STANDARD_DEVIATION 8.8 | 41.6 Years STANDARD_DEVIATION 10.31 | 38.3 Years STANDARD_DEVIATION 12.89 | 47.8 Years STANDARD_DEVIATION 6.21 | 42.7 Years STANDARD_DEVIATION 9.37 |
| Race/Ethnicity, Customized Asian-East Asian Heritage | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 3 Participants | 3 Participants | 2 Participants | 1 Participants | 2 Participants | 3 Participants | 3 Participants | 4 Participants | 3 Participants | 2 Participants | 4 Participants | 31 Participants |
| Race/Ethnicity, Customized Multiple | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White-White/Caucasian/European Heritage | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 5 Participants | 5 Participants | 5 Participants | 6 Participants | 3 Participants | 2 Participants | 32 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 |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 9 Participants | 9 Participants | 9 Participants | 9 Participants | 6 Participants | 6 Participants | 66 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 6 | 0 / 6 | 0 / 5 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 1 / 17 | 0 / 6 | 2 / 6 | 2 / 5 | 2 / 6 | 1 / 6 | 1 / 6 | 4 / 9 | 5 / 9 | 8 / 9 | 3 / 9 | 1 / 11 | 3 / 11 |
| serious Total, serious adverse events | 0 / 17 | 0 / 6 | 0 / 6 | 0 / 5 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 11 | 0 / 11 |
Outcome results
Primary
Apparent Terminal Half-life (T1/2) of GSK3439171A Following Single Dose-Part A (GSK3439171A 5 mg Only)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours post-dose
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Apparent Terminal Half-life (T1/2) of GSK3439171A Following Single Dose-Part A (GSK3439171A 5 mg Only) | 9.847 Hours | Geometric Coefficient of Variation 46.4 |
Primary
Area Under Tha Plasma Drug Concentration Versus Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC[0 to t]) of GSK3439171A Following Single Dose-Part A (GSK3439171A 5 mg Only)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours post-dose
Population: Pharmacokinetic Population comprised of participants in the Safety population for whom a Pharmacokinetic sample was taken and analyzed for GSK3439171A and result reported
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Area Under Tha Plasma Drug Concentration Versus Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC[0 to t]) of GSK3439171A Following Single Dose-Part A (GSK3439171A 5 mg Only) | 1180.6 Hours*nanograms per milliliter | Geometric Coefficient of Variation 48.9 |
Primary
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0 to Inf]) of GSK3439171A Following Single Dose-Part A (GSK3439171A 5 mg Only)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours post-dose
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0 to Inf]) of GSK3439171A Following Single Dose-Part A (GSK3439171A 5 mg Only) | 1247.2 Hours*nanograms per milliliter | Geometric Coefficient of Variation 51.9 |
Primary
AUC(0 to Inf) of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 40 mg Only)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Day 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | AUC(0 to Inf) of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 40 mg Only) | 15098.7 Hours*nanograms per milliliter | Geometric Coefficient of Variation 27.3 |
Primary
AUC(0 to Inf) of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Day 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | AUC(0 to Inf) of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg) | 2129.0 Hours*nanograms per milliliter | Geometric Coefficient of Variation 31.8 |
| Part A: GSK3439171A 5 mg | AUC(0 to Inf) of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg) | 3687.1 Hours*nanograms per milliliter | Geometric Coefficient of Variation 40.2 |
Primary
AUC(0 to Inf) of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | AUC(0 to Inf) of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | 2305.3 Hours*nanograms per milliliter | Geometric Coefficient of Variation 34.5 |
| Part A: GSK3439171A 5 mg | AUC(0 to Inf) of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | 9441.8 Hours*nanograms per milliliter | Geometric Coefficient of Variation 22.2 |
| Part A: GSK3439171A 10 mg | AUC(0 to Inf) of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | 17257.9 Hours*nanograms per milliliter | Geometric Coefficient of Variation 28.7 |
| Part A: GSK3439171A 30 mg | AUC(0 to Inf) of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | 36478.0 Hours*nanograms per milliliter | Geometric Coefficient of Variation 26.1 |
| Part A: GSK3439171A 60 mg | AUC(0 to Inf) of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | 46844.6 Hours*nanograms per milliliter | Geometric Coefficient of Variation 15.2 |
Primary
AUC(0 to Inf) of GSK3439171A Following Single Dose-Part B (GSK3439171A 40 mg Only)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | AUC(0 to Inf) of GSK3439171A Following Single Dose-Part B (GSK3439171A 40 mg Only) | 10182.6 Hours*nanograms per milliliter | Geometric Coefficient of Variation 24.9 |
Primary
AUC(0 to Inf) of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | AUC(0 to Inf) of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg) | 1514.9 Hours*nanograms per milliliter | Geometric Coefficient of Variation 25.1 |
| Part A: GSK3439171A 5 mg | AUC(0 to Inf) of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg) | 2345.6 Hours*nanograms per milliliter | Geometric Coefficient of Variation 31.7 |
Primary
AUC(0 to t) of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 40 mg Only)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Day 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | AUC(0 to t) of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 40 mg Only) | 14896.5 Hours*nanograms per milliliter | Geometric Coefficient of Variation 26.4 |
Primary
AUC(0 to t) of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Day 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | AUC(0 to t) of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg) | 2072.8 Hours*nanograms per milliliter | Geometric Coefficient of Variation 30.7 |
| Part A: GSK3439171A 5 mg | AUC(0 to t) of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg) | 3628.1 Hours*nanograms per milliliter | Geometric Coefficient of Variation 39.6 |
Primary
AUC(0 to t) of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | AUC(0 to t) of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | 2268.6 Hours*nanograms per milliliter | Geometric Coefficient of Variation 34.4 |
| Part A: GSK3439171A 5 mg | AUC(0 to t) of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | 9289.4 Hours*nanograms per milliliter | Geometric Coefficient of Variation 22.3 |
| Part A: GSK3439171A 10 mg | AUC(0 to t) of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | 17052.3 Hours*nanograms per milliliter | Geometric Coefficient of Variation 27.9 |
| Part A: GSK3439171A 30 mg | AUC(0 to t) of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | 35822.0 Hours*nanograms per milliliter | Geometric Coefficient of Variation 25.3 |
| Part A: GSK3439171A 60 mg | AUC(0 to t) of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | 46086.3 Hours*nanograms per milliliter | Geometric Coefficient of Variation 14.4 |
Primary
AUC(0 to t) of GSK3439171A Following Single Dose-Part B (GSK3439171A 40 mg Only)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | AUC(0 to t) of GSK3439171A Following Single Dose-Part B (GSK3439171A 40 mg Only) | 10031.8 Hours*nanograms per milliliter | Geometric Coefficient of Variation 24.5 |
Primary
AUC(0 to t) of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | AUC(0 to t) of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg) | 1474.0 Hours*nanograms per milliliter | Geometric Coefficient of Variation 24.6 |
| Part A: GSK3439171A 5 mg | AUC(0 to t) of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg) | 2299.2 Hours*nanograms per milliliter | Geometric Coefficient of Variation 31.5 |
Primary
Cmax of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 40 mg Only)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Day 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Cmax of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 40 mg Only) | 1016.29 Nanograms per milliliter | Geometric Coefficient of Variation 24.3 |
Primary
Cmax of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Day 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Cmax of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg) | 138.08 Nanograms per milliliter | Geometric Coefficient of Variation 19.3 |
| Part A: GSK3439171A 5 mg | Cmax of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg) | 243.98 Nanograms per milliliter | Geometric Coefficient of Variation 28 |
Primary
Cmax of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Cmax of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | 214.03 Nanograms per milliliter | Geometric Coefficient of Variation 28.1 |
| Part A: GSK3439171A 5 mg | Cmax of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | 635.37 Nanograms per milliliter | Geometric Coefficient of Variation 26.8 |
| Part A: GSK3439171A 10 mg | Cmax of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | 1272.26 Nanograms per milliliter | Geometric Coefficient of Variation 19.4 |
| Part A: GSK3439171A 30 mg | Cmax of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | 2132.49 Nanograms per milliliter | Geometric Coefficient of Variation 19.1 |
| Part A: GSK3439171A 60 mg | Cmax of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | 2938.01 Nanograms per milliliter | Geometric Coefficient of Variation 21.2 |
Primary
Cmax of GSK3439171A Following Single Dose-Part B (GSK3439171A 40 mg Only)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Cmax of GSK3439171A Following Single Dose-Part B (GSK3439171A 40 mg Only) | 682.62 Nanograms per milliliter | Geometric Coefficient of Variation 24.8 |
Primary
Cmax of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Cmax of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg) | 117.40 Nanograms per milliliter | Geometric Coefficient of Variation 25.1 |
| Part A: GSK3439171A 5 mg | Cmax of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg) | 192.62 Nanograms per milliliter | Geometric Coefficient of Variation 20.8 |
Primary
Maximum Observed Plasma Concentration (Cmax) of GSK3439171A Following Single Dose-Part A (GSK3439171A 5 mg Only)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours post-dose
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Maximum Observed Plasma Concentration (Cmax) of GSK3439171A Following Single Dose-Part A (GSK3439171A 5 mg Only) | 111.01 Nanograms per milliliter | Geometric Coefficient of Variation 10.9 |
Primary
Number of Participants With Abnormal ECG Findings-Part B
Twelve-lead ECGs were recorded with the participants in a supine position using an ECG machine that automatically calculated heart rate and measured PR, QRS, QT and QTc intervals. CS and NCS abnormal ECG findings have been presented. CS 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 worst case post-Baseline is presented. Baseline value is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Up to Day 34
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Number of Participants With Abnormal ECG Findings-Part B | NCS | 9 Participants |
| Part A: Placebo | Number of Participants With Abnormal ECG Findings-Part B | CS | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal ECG Findings-Part B | CS | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal ECG Findings-Part B | NCS | 9 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal ECG Findings-Part B | NCS | 8 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal ECG Findings-Part B | CS | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal ECG Findings-Part B | NCS | 9 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal ECG Findings-Part B | CS | 0 Participants |
Primary
Number of Participants With Abnormal ECG Findings-Part C
Twelve-lead ECGs were recorded with the participants in a supine position using an ECG machine that automatically calculated heart rate and measured PR, QRS, QT and QTc intervals. CS and NCS abnormal ECG findings have been presented. CS 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 worst case post-Baseline is presented. Baseline value is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Up to Day 29
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Number of Participants With Abnormal ECG Findings-Part C | NCS | 10 Participants |
| Part A: Placebo | Number of Participants With Abnormal ECG Findings-Part C | CS | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal ECG Findings-Part C | NCS | 11 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal ECG Findings-Part C | CS | 0 Participants |
Primary
Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Part A
Twelve-lead ECGs were recorded with the participants in a supine position using an ECG machine that automatically calculated heart rate and measured PR, QRS, QT and corrected QT (QTc) intervals. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented. CS 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 worst case post-Baseline is presented. Baseline value is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Up to Day 40
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Part A | NCS | 16 Participants |
| Part A: Placebo | Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Part A | CS | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Part A | NCS | 5 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Part A | CS | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Part A | NCS | 6 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Part A | CS | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Part A | NCS | 5 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Part A | CS | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Part A | NCS | 4 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Part A | CS | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Part A | NCS | 6 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Part A | CS | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Part A | NCS | 6 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Part A | CS | 0 Participants |
Primary
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Urine samples were taken for the assessment of following urine parameters: glucose, ketones, occult blood (OB) and protein by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+ indicating proportional concentrations in the urine sample.
Time frame: 8 hours, 24 hours, 48 hours and 72 hours in Periods 1, 2 and 3
Population: Safety Population. All participants in Part A (17, 6, 6, 5, 6, 6, 6) were included in the analysis; however, only 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 | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 24 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 8 hours; 1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 24 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 8 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 72 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 8 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 48 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 24 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 24 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 48 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 24 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 48 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 72 hours; 1+;n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 24 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 24 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 48 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 48 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 72 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 48 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 8 hours;Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 8 hours;2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 8 hours;1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 24 hours;Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 24 hours;1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 24 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 24 hours;2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 48 hours;Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 48 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 48 hours;1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 48 hours;2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 72 hours;Trace;n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 72 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 72 hours;1+;n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 72 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 72 hours;2+;n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 72 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 8 hours;Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 8 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 48 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 8 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 24 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 24 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 24 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 24 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 24 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 48 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 24 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 48 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 72 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 8 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 72 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 72 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 8 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 8 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 8 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 8 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 8 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 24 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 72 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 24 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 24 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 72 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 48 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 48 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 48 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 48 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 72 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 48 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 72 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 72 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 24 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 8 hours; Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 8 hours; 1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 8 hours; 2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 8 hours; 1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 48 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 24 hours; 1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 24 hours; 1+;n=6,6,0,0,6,0,0 | 1 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 24 hours;2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 48 hours; Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 48 hours; Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 48 hours; 1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 48 hours; 1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 48 hours; 2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 72 hours; Trace;n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 24 hours; Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 72 hours; 1+;n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 72 hours; 2+;n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 8 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 8 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 8 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 8 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 8 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 24 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 8 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 24 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 8 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 72 hours; 2+;n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 48 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 48 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 72 hours; Trace;n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 72 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 72 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 48 hours; 2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 8 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 8 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 48 hours; 1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 8 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 24 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 48 hours; Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 24 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 24 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 24 hours;2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 48 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 48 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 24 hours; 1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 72 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 24 hours; Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 72 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 8 hours; Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 8 hours; 2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 72 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 24 hours; Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 24 hours; 1+;n=6,0,6,0,0,6,0 | 1 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 24 hours;2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 72 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 48 hours; 2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 72 hours; Trace;n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 72 hours; 1+;n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 8 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 72 hours; 2+;n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 8 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 8 hours; 2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 8 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 48 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 48 hours; 1+;n=6,0,6,0,0,6,0 | 1 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 8 hours;Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 48 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 72 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 72 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 72 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 72 hours; 1+;n=5,0,0,5,0,0,6 | 1 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 72 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 24 hours; Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 24 hours; Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 24 hours;2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 8 hours; 1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 24 hours;1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 24 hours;2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 24 hours; 1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 48 hours; 1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 24 hours; 1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 8 hours; Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 8 hours; Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 24 hours;2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 8 hours; 1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 24 hours;Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 8 hours; 2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 8 hours; 1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 24 hours; Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 48 hours; 2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 8 hours;1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 8 hours;2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 48 hours; 1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 8 hours;Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 8 hours;Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 48 hours; Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 48 hours; Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 48 hours; Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 48 hours;2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 24 hours;2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 48 hours; 2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 48 hours;1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 8 hours; 2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 8 hours; 2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 48 hours; 2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 48 hours;Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 48 hours; 1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 24 hours; 1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 24 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 48 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 48 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 48 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 72 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 48 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 48 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 72 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 24 hours; 1+;n=6,0,6,0,0,6,0 | 1 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 72 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 48 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 72 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 24 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 72 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 24 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 72 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 24 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 48 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 72 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 8 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 8 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 24 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 24 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 48 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 48 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 8 hours;Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 8 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 8 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 8 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 24 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 24 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 24 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 8 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 8 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 48 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 8 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 48 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 72 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 8 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 72 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 8 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 72 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 24 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 8 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 48 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 72 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 24 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 72 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 48 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 48 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 24 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 8 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 24 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 24 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 24 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 72 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 8 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 72 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 72 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 8 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 24 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 24 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 72 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 72 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 24 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 24 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 8 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 8 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 48 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 72 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 48 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 8 hours; 1+;n=5,0,0,5,0,0,6 | 1 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 48 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 8 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 8 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 72 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 48 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 72 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 48 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 24 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 72 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 24 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 8 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 48 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 24 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 72 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 8 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 72 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 8 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 48 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 48 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 48 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 24 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 8 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 72 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 48 hours; 2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 8 hours;Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 48 hours; 2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 8 hours; Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 24 hours; Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 48 hours; Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 72 hours; Trace;n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 72 hours; 1+;n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 8 hours;1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 8 hours;2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 24 hours;Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 24 hours;1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 24 hours;2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 48 hours;Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 48 hours;1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 48 hours;2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 72 hours;Trace;n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 72 hours;1+;n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 1; 72 hours;2+;n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 8 hours;Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 8 hours; Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 8 hours; 1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 8 hours; 2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 24 hours; Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 24 hours; 1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 24 hours;2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 48 hours; Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 48 hours; 1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 72 hours; Trace;n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 72 hours; 1+;n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 1; 72 hours; 2+;n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 8 hours; 1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 8 hours; 2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 24 hours; 1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 24 hours;2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 48 hours; 1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 72 hours; 1+;n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 1; 72 hours; 2+;n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 8 hours;Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 8 hours; 1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 8 hours; 2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 24 hours; Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 24 hours; 1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 24 hours;2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 48 hours; Trace;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 48 hours; 1+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 48 hours; 2+;n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 72 hours; Trace;n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 1; 72 hours; 2+;n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 24 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 72 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 48 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 48 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 24 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 24 hours; 1+;n=6,0,6,0,0,6,0 | 1 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 8 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 48 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 8 hours; 1+;n=6,0,6,0,0,6,0 | 1 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 24 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 48 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 72 hours; 1+;n=6,0,6,0,0,6,0 | 1 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 8 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 72 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 72 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 72 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 48 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 48 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 48 hours; Trace;n=6,0,6,0,0,6,0 | 00 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 24 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 24 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 8 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 24 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 8 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 8 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 8 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 2; 8 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 8 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 24 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 24 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 48 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 48 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 72 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 72 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 2; 72 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 72 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 72 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 72 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 48 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 48 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 48 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 24 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 24 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 24 hours; Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 8 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 8 hours; 1+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 2; 8 hours;Trace;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 2; 72 hours; 2+;n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 72 hours; 1+;n=5,0,0,5,0,0,6 | 2 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 24 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 72 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 72 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 48 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 8 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 48 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 48 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 48 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 48 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 24 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 72 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 24 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 72 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 72 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 48 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 48 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 48 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 24 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 24 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 24 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 24 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 24 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 8 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 8 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 8 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Ketones; Period 3; 8 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 72 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 8 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 72 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 8 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 8 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 8 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 48 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 72 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 72 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 8 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 24 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 48 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 8 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 24 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 24 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Protein; Period 3; 24 hours; Trace;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 48 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 72 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Glucose; Period 3; 72 hours; 1+;n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | OB; Period 3; 8 hours; 2+;n=5,0,0,5,0,0,6 | 0 Participants |
Primary
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Urine samples were taken for the assessment of following urine parameters: glucose, ketones, OB and protein by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+ indicating proportional concentrations in the urine sample.
Time frame: Day 2 (24 hours); Day 3 (48 hours); Days 4, 13 and 20 (72 hours); pre-dose on Days 7, 10, 11 and 17
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day13, 72 hours; 1+; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day20, 72 hours; Trace; n=6,9,7,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day10, pre-dose; 1+; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day4, 72 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day20, 72 hours; 1+; n=6,9,7,0 | 1 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day4, 72 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day10, pre-dose; Trace; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day4, 72 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day13, 72 hours; 2+; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day3, 48 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day17, pre-dose; Trace; n=6,9,8,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day4, 72 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day10, pre-dose; 2+; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day2, 24 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day7, pre-dose; 2+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day7, pre-dose; Trace; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day17, pre-dose; Trace; n=6,9,8,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day17, pre-dose; 1+; n=6,9,8,0 | 1 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day7, pre-dose; 1+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day7, pre-dose; 1+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day2, 24 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day4, 72 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day7, pre-dose; 1+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day7, pre-dose; 2+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day17, pre-dose; 2+; n=6,9,8,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day3, 48 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day11, pre-dose; 2+; n=6,9,9,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day10, pre-dose; Trace; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day7, pre-dose; Trace; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day10, pre-dose; 1+; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day20, 72 hours; Trace; n=6,9,7,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day10, pre-dose; 2+; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day4, 72 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day 11, pre-dose; Trace; n=6,9,9,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day13, 72 hours; 1+; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day2, 24 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day11, pre-dose; 1+; n=6,9,9,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day13, 72 hours; Trace; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day17, pre-dose; 2+; n=6,9,8,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day11, pre-dose; 2+; n=6,9,9,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day13, 72 hours; Trace; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day7, pre-dose; Trace; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day13, 72 hours; Trace; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day13, 72 hours; 1+; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day13, 72 hours; 1+; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day4, 72 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day13, 72 hours; 2+; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day7, pre-dose; 2+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day17, pre-dose; Trace; n=6,9,8,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day13, 72 hours; 2+; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day11, pre-dose; 2+; n=6,9,9,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day17, pre-dose; 1+; n=6,9,8,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day17, pre-dose; Trace; n=6,9,8,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day2, 24 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day17, pre-dose; 2+; n=6,9,8,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day4, 72 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day3, 48 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day20, 72 hours; Trace; n=6,9,7,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day17, pre-dose; 1+; n=6,9,8,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day7, pre-dose; 1+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day20, 72 hours; 1+; n=6,9,7,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day 11, pre-dose; Trace; n=6,9,9,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day10, pre-dose; Trace; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day20, 72 hours; 2+; n=6,9,7,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day17, pre-dose; 2+; n=6,9,8,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day20, 72 hours; 2+; n=6,9,7,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day2, 24 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day10, pre-dose; Trace; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day17, pre-dose; 1+; n=6,9,8,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day4, 72 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day2, 24 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day2, 24 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day7, pre-dose; 2+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day20, 72 hours; Trace; n=6,9,7,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day2, 24 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day10, pre-dose; 1+; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day20, 72 hours; 1+; n=6,9,7,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day3, 48 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day3, 48 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day20, 72 hours; 1+; n=6,9,7,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day3, 48 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day10, pre-dose; 1+; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day3, 48 hours; 1+; n=9,9,9,9 | 1 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day3, 48 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day20, 72 hours; 2+; n=6,9,7,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day10, pre-dose; 2+; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day20, 72 hours; 2+; n=6,9,7,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day2, 24 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day 11, pre-dose; Trace; n=6,9,9,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day3, 48 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day4, 72 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day2, 24 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day11, pre-dose; 1+; n=6,9,9,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day4, 72 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day11, pre-dose; 1+; n=6,9,9,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day2, 24 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day13, 72 hours; 2+; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day4, 72 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day11, pre-dose; 2+; n=6,9,9,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day3, 48 hours; Trace; ; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day2, 24 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day 11, pre-dose; 1+; n=6,9,9,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day 11, pre-dose; Trace; n=6,9,9,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day3, 48 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day13, 72 hours; Trace; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day7, pre-dose; Trace; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day10, pre-dose; 2+; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day3, 48 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day3, 48 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day3, 48 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day3, 48 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day4, 72 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day4, 72 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day2, 24 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day4, 72 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day7, pre-dose; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day2, 24 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day7, pre-dose; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day7, pre-dose; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day2, 24 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day20, 72 hours; 2+; n=6,9,7,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day 11, pre-dose; Trace; n=6,9,9,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day 11, pre-dose; Trace; n=6,9,9,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day11, pre-dose; 1+; n=6,9,9,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day3, 48 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day11, pre-dose; 2+; n=6,9,9,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day20, 72 hours; 1+; n=6,9,7,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day20, 72 hours; Trace; n=6,9,7,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day17, pre-dose; Trace; n=6,9,8,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day 11, pre-dose; 1+; n=6,9,9,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day17, pre-dose; 1+; n=6,9,8,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day17, pre-dose; 2+; n=6,9,8,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day11, pre-dose; 2+; n=6,9,9,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day20, 72 hours; 1+; n=6,9,7,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day11, pre-dose; 2+; n=6,9,9,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day17, pre-dose; Trace; n=6,9,8,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day17, pre-dose; 1+; n=6,9,8,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day3, 48 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day17, pre-dose; 2+; n=6,9,8,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day2, 24 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day20, 72 hours; Trace; n=6,9,7,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day20, 72 hours; 1+; n=6,9,7,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day20, 72 hours; 2+; n=6,9,7,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day3, 48 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day2, 24 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day2, 24 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day11, pre-dose; 1+; n=6,9,9,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day2, 24 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day20, 72 hours; Trace; n=6,9,7,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day2, 24 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day 11, pre-dose; Trace; n=6,9,9,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day3, 48 hours; Trace; ; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day4, 72 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day3, 48 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day20, 72 hours; 2+; n=6,9,7,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day3, 48 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day4, 72 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day4, 72 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day4, 72 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day7, pre-dose; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day4, 72 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day7, pre-dose; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day17, pre-dose; 2+; n=6,9,8,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day7, pre-dose; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day7, pre-dose; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day7, pre-dose; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day4, 72 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day7, pre-dose; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day4, 72 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day 11, pre-dose; Trace; n=6,9,9,0 | 1 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day2, 24 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day11, pre-dose; 1+; n=6,9,9,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day11, pre-dose; 2+; n=6,9,9,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day4, 72 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day4, 72 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day17, pre-dose; Trace; n=6,9,8,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day7, pre-dose; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day17, pre-dose; 1+; n=6,9,8,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day17, pre-dose; 2+; n=6,9,8,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day17, pre-dose; 1+; n=6,9,8,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day20, 72 hours; Trace; n=6,9,7,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day20, 72 hours; 1+; n=6,9,7,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day7, pre-dose; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day20, 72 hours; 2+; n=6,9,7,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day2, 24 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day2, 24 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day3, 48 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day2, 24 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day7, pre-dose; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day3, 48 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day3, 48 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day17, pre-dose; Trace; n=6,9,8,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day20, 72 hours; 2+; n=6,9,7,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day2, 24 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day2, 24 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day2, 24 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day3, 48 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day3, 48 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day3, 48 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day4, 72 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day4, 72 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day4, 72 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day7, pre-dose; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day7, pre-dose; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day7, pre-dose; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day 11, pre-dose; Trace; n=6,9,9,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day 11, pre-dose; 1+; n=6,9,9,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day11, pre-dose; 2+; n=6,9,9,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day17, pre-dose; Trace; n=6,9,8,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day17, pre-dose; 1+; n=6,9,8,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day17, pre-dose; 2+; n=6,9,8,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day20, 72 hours; Trace; n=6,9,7,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day20, 72 hours; 1+; n=6,9,7,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day20, 72 hours; 2+; n=6,9,7,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day2, 24 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day2, 24 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day2, 24 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day3, 48 hours; Trace; ; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day3, 48 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day3, 48 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day4, 72 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day4, 72 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day4, 72 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day7, pre-dose; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day7, pre-dose; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day7, pre-dose; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day 11, pre-dose; Trace; n=6,9,9,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day11, pre-dose; 1+; n=6,9,9,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day11, pre-dose; 2+; n=6,9,9,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day17, pre-dose; Trace; n=6,9,8,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day17, pre-dose; 1+; n=6,9,8,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day17, pre-dose; 2+; n=6,9,8,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day20, 72 hours; Trace; n=6,9,7,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day20, 72 hours; 1+; n=6,9,7,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day20, 72 hours; 2+; n=6,9,7,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day2, 24 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day2, 24 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day2, 24 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day3, 48 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day3, 48 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day3, 48 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day4, 72 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day4, 72 hours; 1+; n=9,9,9,9 | 1 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day4, 72 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day7, pre-dose; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day7, pre-dose; 1+; n=9,9,9,9 | 1 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day7, pre-dose; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day 11, pre-dose; Trace; n=6,9,9,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day11, pre-dose; 1+; n=6,9,9,0 | 1 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day11, pre-dose; 2+; n=6,9,9,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day17, pre-dose; Trace; n=6,9,8,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day17, pre-dose; 1+; n=6,9,8,0 | 1 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day17, pre-dose; 2+; n=6,9,8,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day20, 72 hours; Trace; n=6,9,7,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day20, 72 hours; 1+; n=6,9,7,0 | 2 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day20, 72 hours; 2+; n=6,9,7,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day2, 24 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day2, 24 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day2, 24 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day3, 48 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day3, 48 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day3, 48 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day4, 72 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day4, 72 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day4, 72 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day7, pre-dose; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day7, pre-dose; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day7, pre-dose; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day 11, pre-dose; Trace; n=6,9,9,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day11, pre-dose; 1+; n=6,9,9,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day11, pre-dose; 2+; n=6,9,9,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day17, pre-dose; Trace; n=6,9,8,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day17, pre-dose; 1+; n=6,9,8,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day17, pre-dose; 2+; n=6,9,8,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day20, 72 hours; Trace; n=6,9,7,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day20, 72 hours; 1+; n=6,9,7,0 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day3, 48 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day3, 48 hours; 1+; n=9,9,9,9 | 2 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day3, 48 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day3, 48 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day3, 48 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day2, 24 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day2, 24 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day7, pre-dose; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day3, 48 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day2, 24 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day13, 72 hours; 2+; n=3,0,0,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day7, pre-dose; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day4, 72 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day13, 72 hours; 1+; n=3,0,0,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day13, 72 hours; Trace; n=3,0,0,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day2, 24 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day4, 72 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day10, pre-dose; 2+; n=3,0,0,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day10, pre-dose; 1+; n=3,0,0,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day4, 72 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day4, 72 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day10, pre-dose; Trace; n=3,0,0,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day7, pre-dose; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day4, 72 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day7, pre-dose; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day7, pre-dose; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day7, pre-dose; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day2, 24 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day7, pre-dose; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day4, 72 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day4, 72 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day4, 72 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day7, pre-dose; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day4, 72 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day10, pre-dose; Trace; n=3,0,0,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day3, 48 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day10, pre-dose; 1+; n=3,0,0,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day3, 48 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day10, pre-dose; 2+; n=3,0,0,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day3, 48 hours; Trace; ; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day2, 24 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day3, 48 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day2, 24 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Ketones; Day2, 24 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day2, 24 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day13, 72 hours; 2+; n=3,0,0,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day13, 72 hours; 1+; n=3,0,0,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day3, 48 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day13, 72 hours; Trace; n=3,0,0,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day13, 72 hours; 2+; n=3,0,0,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day13, 72 hours; Trace; n=3,0,0,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day13, 72 hours; 1+; n=3,0,0,9 | 1 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day13, 72 hours; Trace; n=3,0,0,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day10, pre-dose; 2+; n=3,0,0,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day10, pre-dose; 2+; n=3,0,0,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day10, pre-dose; 1+; n=3,0,0,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day13, 72 hours; 1+; n=3,0,0,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day10, pre-dose; Trace; n=3,0,0,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day7, pre-dose; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day10, pre-dose; 1+; n=3,0,0,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day2, 24 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day7, pre-dose; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day7, pre-dose; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day13, 72 hours; 2+; n=3,0,0,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day2, 24 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day4, 72 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day4, 72 hours; 1+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day10, pre-dose; Trace; n=3,0,0,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Protein; Day2, 24 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day4, 72 hours; Trace; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | OB; Day3, 48 hours; 2+; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Glucose; Day7, pre-dose; 2+; n=9,9,9,9 | 0 Participants |
Primary
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Urine samples were taken for the assessment of following urine parameters: glucose, ketones, OB and protein by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+ indicating proportional concentrations in the urine sample.
Time frame: 8 hours, 24 hours, 48 hours and 72 hours in Period 1 and Period 2
Population: Safety Population. All participants in Part C (11, 11) were included in the analysis; however, only 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 | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 1, 8 hours; Trace; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 1, 8 hours; 1+; n=6, 6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 1, 8 hours; 2+; n=6, 6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 1, 24 hours; Trace; n=6, 6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 1, 24 hours; 1+; n=6, 6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 1, 24 hours; 2+; n=6, 6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 1, 48 hours; Trace; n=6, 6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 1, 48 hours; 1+; n=6, 6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 1, 48 hours; 2+; n=6, 6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 1, 72 hours; Trace; n=6, 6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 1, 72 hours; 1+; n=6, 6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 1, 72 hours; 2+; n=6, 6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 2, 8 hours; Trace; n=5, 5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 2, 8 hours; 1+; n=5, 5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 2, 8 hours; 2+;n=5, 5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 2, 24 hours; Trace; n=5, 5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 2, 24 hours; 1+; n=5, 5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 2, 24 hours; 2+; n=5, 5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 2, 48 hours; Trace; n=5, 5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 2, 48 hours; 1+; n=5, 5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 2, 48 hours; 2+; n=5, 5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 2, 72 hours; Trace; n=5, 5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 2, 72 hours; 1+; n=5, 5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 2, 72 hours; 2+; n=5, 5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 1, 8 hours; Trace; n=6, 6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 1, 8 hours; 1+; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 1, 8 hours; 2+; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 1, 24 hours; Trace; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 1, 24 hours; 1+; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 1, 24 hours; 2+; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 1, 48 hours; Trace; n=6,6 | 1 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 1, 48 hours; 1+; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 1, 48 hours; 2+; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 1, 72 hours; Trace; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 1, 72 hours; 1+; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 1, 72 hours; 2+; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 2, 8 hours; Trace; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 2, 8 hours; 1+; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 2, 8 hours; 2+; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 2, 24 hours; Trace; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 2, 24 hours; 1+; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 2, 24 hours; 2+; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 2, 48 hours; Trace; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 2, 48 hours; 1+; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 2, 48 hours; 2+; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 2, 72 hours; Trace; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 2, 72 hours; 1+; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 2, 72 hours; 2+; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 1, 8 hours; Trace; n=6, 6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 1, 8 hours; 1+; n=6, 6 | 1 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 1, 8 hours; 2+; n=6, 6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 1, 24 hours; Trace; n=6, 6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 1, 24 hours; 1+; n=6, 6 | 1 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 1, 24 hours; 2+; n=6, 6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 1, 48 hours; Trace; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 1, 48 hours; 1+; n=6, 6 | 1 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 1, 48 hours; 2+; n=6, 6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 1, 72 hours; Trace; n=6, 6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 1, 72 hours; 1+; n=6, 6 | 2 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 1, 72 hours; 2+; n=6, 6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 2, 8 hours; Trace; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 2, 8 hours; 1+; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 2, 8 hours; 2+; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 2, 24 hours; Trace; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 2, 24 hours; 1+; n=5,5 | 1 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 2, 24 hours; 2+; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 2, 48 hours; Trace; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 2, 48 hours; 1+; n=5,5 | 1 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 2, 48 hours; 2+; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 2, 72 hours; Trace; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 2, 72 hours; 1+; n=5,5 | 1 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 2, 72 hours; 2+; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 1, 8 hours; Trace; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 1, 8 hours; 1+; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 1, 8 hours; 2+; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 1, 24 hours; Trace; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 1, 24 hours; 1+; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 1, 24 hours; 2+; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 1, 48 hours; Trace; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 1, 48 hours; 1+; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 1, 48 hours; 2+; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 1, 72 hours; Trace; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 1, 72 hours; 1+; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 1, 72 hours; 2+; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 2, 8 hours; Trace; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 2, 8 hours; 1+; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 2, 8 hours; 2+; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 2, 24 hours; Trace; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 2, 24 hours; 1+; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 2, 24 hours; 2+; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 2, 48 hours; Trace;n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 2, 48 hours; 1+;n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 2, 48 hours; 2+;n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 2, 72 hours; Trace; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 2, 72 hours; 1+; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 2, 72 hours; 2+; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 2, 72 hours; 1+; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 1, 8 hours; Trace; n=6, 6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 1, 8 hours; Trace; n=6, 6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 1, 8 hours; 1+; n=6, 6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 1, 8 hours; Trace; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 1, 8 hours; 2+; n=6, 6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 1, 8 hours; 1+; n=6, 6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 1, 24 hours; Trace; n=6, 6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 2, 8 hours; Trace; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 1, 24 hours; 1+; n=6, 6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 1, 8 hours; 2+; n=6, 6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 1, 24 hours; 2+; n=6, 6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 1, 8 hours; 1+; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 1, 48 hours; Trace; n=6, 6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 1, 24 hours; Trace; n=6, 6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 1, 48 hours; 1+; n=6, 6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 2, 48 hours; Trace;n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 1, 48 hours; 2+; n=6, 6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 1, 24 hours; 1+; n=6, 6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 1, 72 hours; Trace; n=6, 6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 1, 8 hours; 2+; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 1, 72 hours; 1+; n=6, 6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 1, 24 hours; 2+; n=6, 6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 1, 72 hours; 2+; n=6, 6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 2, 8 hours; 1+; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 2, 8 hours; Trace; n=5, 5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 1, 48 hours; Trace; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 2, 8 hours; 1+; n=5, 5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 1, 24 hours; Trace; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 2, 8 hours; 2+;n=5, 5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 1, 48 hours; 1+; n=6, 6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 2, 24 hours; Trace; n=5, 5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 2, 72 hours; Trace; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 2, 24 hours; 1+; n=5, 5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 1, 48 hours; 2+; n=6, 6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 2, 24 hours; 2+; n=5, 5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 1, 24 hours; 1+; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 2, 48 hours; Trace; n=5, 5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 1, 72 hours; Trace; n=6, 6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 2, 48 hours; 1+; n=5, 5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 2, 8 hours; 2+; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 2, 48 hours; 2+; n=5, 5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 1, 72 hours; 1+; n=6, 6 | 1 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 2, 72 hours; Trace; n=5, 5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 1, 24 hours; 2+; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 2, 72 hours; 1+; n=5, 5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 1, 72 hours; 2+; n=6, 6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Glucose; Period 2, 72 hours; 2+; n=5, 5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 2, 48 hours; 1+;n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 1, 8 hours; Trace; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 2, 8 hours; Trace; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 1, 8 hours; 1+; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 1, 48 hours; Trace; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 1, 8 hours; 2+; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 2, 8 hours; 1+; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 1, 24 hours; Trace; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 2, 24 hours; Trace; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 1, 24 hours; 1+; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 2, 8 hours; 2+; n=5,5 | 1 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 1, 24 hours; 2+; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 1, 48 hours; 1+; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 1, 48 hours; Trace; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 2, 24 hours; Trace; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 1, 48 hours; 1+; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 2, 72 hours; 2+; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 1, 48 hours; 2+; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 2, 24 hours; 1+; n=5,5 | 1 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 1, 72 hours; Trace; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 1, 48 hours; 2+; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 1, 72 hours; 1+; n=6,6 | 1 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 2, 24 hours; 2+; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 1, 72 hours; 2+; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 2, 24 hours; 1+; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 2, 8 hours; Trace; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 2, 48 hours; Trace; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 2, 8 hours; 1+; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 1, 72 hours; Trace; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 2, 8 hours; 2+; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 2, 48 hours; 1+; n=5,5 | 1 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 2, 24 hours; Trace; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 2, 48 hours; 2+;n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 2, 24 hours; 1+; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 2, 48 hours; 2+; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 2, 24 hours; 2+; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 1, 72 hours; 1+; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 2, 48 hours; Trace; n=5,5 | 1 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 2, 72 hours; Trace; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 2, 48 hours; 1+; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 2, 24 hours; 2+; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 2, 48 hours; 2+; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 2, 72 hours; 1+; n=5,5 | 1 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 2, 72 hours; Trace; n=5,5 | 1 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Protein; Period 1, 72 hours; 2+; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 2, 72 hours; 1+; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | OB; Period 2, 72 hours; 2+; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Ketone; Period 2, 72 hours; 2+; n=5,5 | 0 Participants |
Primary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part A
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before.
Time frame: Up to Day 40
Population: Safety Population comprised of all participants who took at least one dose of study intervention. Participants were analyzed according to the intervention they actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part A | Any AE | 1 Participants |
| Part A: Placebo | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part A | Any SAE | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part A | Any AE | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part A | Any SAE | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part A | Any SAE | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part A | Any AE | 2 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part A | Any AE | 2 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part A | Any SAE | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part A | Any AE | 2 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part A | Any SAE | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part A | Any AE | 1 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part A | Any SAE | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part A | Any AE | 1 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part A | Any SAE | 0 Participants |
Primary
Number of Participants With AEs and SAEs-Part B
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before.
Time frame: Up to Day 34
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Number of Participants With AEs and SAEs-Part B | Any AE | 4 Participants |
| Part A: Placebo | Number of Participants With AEs and SAEs-Part B | Any SAE | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With AEs and SAEs-Part B | Any SAE | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With AEs and SAEs-Part B | Any AE | 5 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With AEs and SAEs-Part B | Any AE | 8 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With AEs and SAEs-Part B | Any SAE | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With AEs and SAEs-Part B | Any AE | 3 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With AEs and SAEs-Part B | Any SAE | 0 Participants |
Primary
Number of Participants With AEs and SAEs-Part C
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before.
Time frame: Up to Day 29
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Number of Participants With AEs and SAEs-Part C | Any AE | 1 Participants |
| Part A: Placebo | Number of Participants With AEs and SAEs-Part C | Any SAE | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With AEs and SAEs-Part C | Any AE | 3 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With AEs and SAEs-Part C | Any SAE | 0 Participants |
Primary
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance-Part A
Blood samples were collected for the assessment of clinical chemistry parameters. The clinical concern range for the parameters were: albumin (low: \<30 grams per liter \[g/L\]); alanine aminotransferase (ALT) (high: \>=2xupper limit of normal \[ULN\]); aspartate aminotransferase (AST) (high: \>=2xULN); alkaline phosphatase (ALP) (high: \>=2xULN); total bilirubin (high: \>=1.5xULN); calcium (low: \<2 millimoles (mmol)/L and high: \>2.75 mmol/L); creatinine (high: change from Baseline \>44.2 micromoles/L); glucose (low: \<3 mmol/L and high: \>9 mmol/L); magnesium (low: 0.5 mmol/L and high: 1.23 mmol/L); phosphorus (low: 0.8 mmol/L and high: 1.6 mmol/L); potassium (low: \<3 mmol/L and high: \>5.5 mmol/L); sodium (low: \<130 mmol/L and high: \>150 mmol/L) and creatine kinase (high: \>500 units per liter). The number of participants with any clinical chemistry abnormality of potential clinical importance is reported.
Time frame: Up to Day 40
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Placebo | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance-Part A | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance-Part A | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance-Part A | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance-Part A | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance-Part A | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance-Part A | 1 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance-Part A | 1 Participants |
Primary
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance-Part B
Blood samples were collected for the assessment of clinical chemistry parameters. The clinical concern range for the parameters were: albumin (low: \<30 g/L); ALT (high: \>=2xULN); AST (high: \>=2xULN); ALP (high: \>=2xULN); total bilirubin (high: \>=1.5xULN); calcium (low: \<2 mmol/L and high: \>2.75 mmol/L); creatinine (high: change from Baseline \>44.2 micromoles/L); glucose (low: \<3 mmol/L and high: \>9 mmol/L); magnesium (low: 0.5 mmol/L and high: 1.23 mmol/L); phosphorus (low: 0.8 mmol/L and high: 1.6 mmol/L); potassium (low: \<3 mmol/L and high: \>5.5 mmol/L); sodium (low: \<130 mmol/L and high: \>150 mmol/L) and creatine kinase (high: \>500 units per liter). The number of participants with any clinical chemistry abnormality of potential clinical importance is reported.
Time frame: Up to Day 34
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Placebo | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance-Part B | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance-Part B | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance-Part B | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance-Part B | 1 Participants |
Primary
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance-Part C
Blood samples were collected for the assessment of clinical chemistry parameters. The clinical concern range for the parameters were: albumin (low: \<30 g/L); ALT (high: \>=2xULN); AST (high: \>=2xULN); ALP (high: \>=2xULN); total bilirubin (high: \>=1.5xULN); calcium (low: \<2 mmol/L and high: \>2.75 mmol/L); creatinine (high: change from Baseline \>44.2 micromoles/L); glucose (low: \<3 mmol/L and high: \>9 mmol/L); magnesium (low: 0.5 mmol/L and high: 1.23 mmol/L); phosphorus (low: 0.8 mmol/L and high: 1.6 mmol/L); potassium (low: \<3 mmol/L and high: \>5.5 mmol/L); sodium (low: \<130 mmol/L and high: \>150 mmol/L) and creatine kinase (high: \>500 units per liter). The number of participants with any clinical chemistry abnormality of potential clinical importance is reported.
Time frame: Up to Day 29
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Placebo | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance-Part C | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance-Part C | 0 Participants |
Primary
Number of Participants With Hematology Abnormalities of Potential Clinical Importance-Part A
Blood samples were collected for the assessment of hematology parameters. The clinical concern range for the parameters were: hematocrit (high: \>0.54 proportion of red blood cells in blood); hemoglobin (high: \>180 g/L), lymphocytes (low: \<0.8x10\^9 cells per liter \[cells/L\]); neutrophil count (low: \<1.5x10\^9 cells/L); platelet count (low: \<100x10\^9 cells/L and high: \>550x10\^9 cells/L); white blood cells count (low: \<3x10\^9 cells/L and high: \>20x10\^9 cells/L). The number of participants with any hematology abnormality of potential clinical importance is reported.
Time frame: Up to Day 40
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Placebo | Number of Participants With Hematology Abnormalities of Potential Clinical Importance-Part A | 2 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Hematology Abnormalities of Potential Clinical Importance-Part A | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Hematology Abnormalities of Potential Clinical Importance-Part A | 1 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Hematology Abnormalities of Potential Clinical Importance-Part A | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Hematology Abnormalities of Potential Clinical Importance-Part A | 1 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Hematology Abnormalities of Potential Clinical Importance-Part A | 1 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Hematology Abnormalities of Potential Clinical Importance-Part A | 1 Participants |
Primary
Number of Participants With Hematology Abnormalities of Potential Clinical Importance-Part B
Blood samples were collected for the assessment of hematology parameters. The clinical concern range for the parameters were: hematocrit (high: \>0.54 proportion of red blood cells in blood); hemoglobin (high: \>180 g/L), lymphocytes (low: \<0.8x10\^9 cells/L); neutrophil count (low: \<1.5x10\^9 cells/L); platelet count (low: \<100x10\^9 cells/L and high: \>550x10\^9 cells/L); white blood cells count (low: \<3x10\^9 cells/L and high: \>20x10\^9 cells/L). The number of participants with any hematology abnormality of potential clinical importance is reported.
Time frame: Up to Day 34
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Placebo | Number of Participants With Hematology Abnormalities of Potential Clinical Importance-Part B | 3 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Hematology Abnormalities of Potential Clinical Importance-Part B | 3 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Hematology Abnormalities of Potential Clinical Importance-Part B | 2 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Hematology Abnormalities of Potential Clinical Importance-Part B | 1 Participants |
Primary
Number of Participants With Hematology Abnormalities of Potential Clinical Importance-Part C
Blood samples were collected for the assessment of hematology parameters. The clinical concern range for the parameters were: hematocrit (high: \>0.54 proportion of red blood cells in blood); hemoglobin (high: \>180 g/L), lymphocytes (low: \<0.8x10\^9 cells/L); neutrophil count (low: \<1.5x10\^9 cells/L); platelet count (low: \<100x10\^9 cells/L and high: \>550x10\^9 cells/L); white blood cells count (low: \<3x10\^9 cells/L and high: \>20x10\^9 cells/L). The number of participants with any hematology abnormality of potential clinical importance is reported.
Time frame: Up to Day 29
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Placebo | Number of Participants With Hematology Abnormalities of Potential Clinical Importance-Part C | 5 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Hematology Abnormalities of Potential Clinical Importance-Part C | 3 Participants |
Primary
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Urine samples were taken for the assessment of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 to 6.0). Dipstick test results for pH were presented as number of participants having pH value as 5, 6, 7, 8 or 9.
Time frame: 8 hours, 24 hours, 48 hours and 72 hours in Periods 1, 2 and 3
Population: Safety Population. All participants in Part A (17, 6, 6, 5, 6, 6, 6) were included in the analysis; however, only 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 | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | -Period 2; 48 hours; pH=5; n=6,0,6,0,0,6,0 | 3 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 24 hours; pH=5; n=6,0,6,0,0,6,0 | 3 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 72 hours; pH=8; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 24 hours; pH=9; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 24 hours; pH=6; n=6,0,6,0,0,6,0 | 3 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 72 hours; pH=7; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 72 hours; pH=5; n=5,0,0,5,0,0,6 | 1 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 24 hours; pH=8; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 24 hours; pH=7; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 8 hours; pH=6; n=6,6,0,0,6,0,0 | 1 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 48 hours; pH=9; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 48 hours; pH=8; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 48 hours; pH=6; n=5,0,0,5,0,0,6 | 2 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 48 hours; pH=7; n=5,0,0,5,0,0,6 | 1 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 48 hours; pH=5; n=5,0,0,5,0,0,6 | 2 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 72 hours; pH=6; n=5,0,0,5,0,0,6 | 4 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 24 hours; pH=9; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 8 hours; pH=5; n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 72 hours; pH=6; n=6,0,6,0,0,6,0 | 5 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 72 hours; pH=8; n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 72 hours; pH=5; n=6,0,6,0,0,6,0 | 1 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 72 hours; pH=9; n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 48 hours; pH=9; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 8 hours; pH=5; n=6,0,6,0,0,6,0 | 1 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 8 hours; pH=7; n=6,6,0,0,6,0,0 | 3 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 48 hours; pH=8; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 8 hours; pH=6; n=6,0,6,0,0,6,0 | 2 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 48 hours; pH=7; n=6,0,6,0,0,6,0 | 1 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 8 hours; pH=7; n=6,0,6,0,0,6,0 | 3 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 8 hours; pH=8; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 72 hours; pH=9; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 48 hours; pH=6; n=6,0,6,0,0,6,0 | 2 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 8 hours; pH=9; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 24 hours; pH=8; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 24 hours; pH=7; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 8 hours; pH=8; n=6,6,0,0,6,0,0 | 2 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 24 hours; pH=6; n=5,0,0,5,0,0,6 | 3 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 8 hours; pH=9; n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 24 hours; pH=5; n=6,6,0,0,6,0,0 | 4 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 24 hours; pH=5; n=5,0,0,5,0,0,6 | 2 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 24 hours; pH=6; n=6,6,0,0,6,0,0 | 2 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 24 hours; pH=7; n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 24 hours; pH=8; n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 8 hours; pH=9; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 24 hours; pH=9; n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 48 hours; pH=5; n=6,6,0,0,6,0,0 | 1 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 8 hours; pH=8; n=5,0,0,5,0,0,6 | 2 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 48 hours; pH=6; n=6,6,0,0,6,0,0 | 4 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 8 hours; pH=7; n=5,0,0,5,0,0,6 | 2 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 48 hours; pH=7; n=6,6,0,0,6,0,0 | 1 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 8 hours; pH=6; n=5,0,0,5,0,0,6 | 1 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 48 hours; pH=8; n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 8 hours; pH=5; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 48 hours; pH=9; n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 72 hours; pH=9; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 72 hours; pH=5; n=3,0,0,0,6,0,0 | 2 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 72 hours; pH=8; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 72 hours; pH=6; n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 72 hours; pH=7; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 72 hours; pH=7; n=3,0,0,0,6,0,0 | 1 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 8 hours; pH=5; n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 8 hours; pH=6; n=6,6,0,0,6,0,0 | 1 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 48 hours; pH=6; n=6,6,0,0,6,0,0 | 3 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 8 hours; pH=7; n=6,6,0,0,6,0,0 | 5 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 24 hours; pH=8; n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 48 hours; pH=8; n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 8 hours; pH=8; n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 24 hours; pH=6; n=6,6,0,0,6,0,0 | 3 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 24 hours; pH=9; n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 48 hours; pH=7; n=6,6,0,0,6,0,0 | 2 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 24 hours; pH=5; n=6,6,0,0,6,0,0 | 3 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 48 hours; pH=5; n=6,6,0,0,6,0,0 | 1 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 8 hours; pH=9; n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 48 hours; pH=9; n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 24 hours; pH=7; n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 24 hours; pH=8; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 8 hours; pH=7; n=6,0,6,0,0,6,0 | 6 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 8 hours; pH=5; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 8 hours; pH=6; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 8 hours; pH=8; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 8 hours; pH=9; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 24 hours; pH=5; n=6,0,6,0,0,6,0 | 2 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 48 hours; pH=9; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 24 hours; pH=6; n=6,0,6,0,0,6,0 | 3 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 24 hours; pH=7; n=6,0,6,0,0,6,0 | 1 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 24 hours; pH=9; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | -Period 2; 48 hours; pH=5; n=6,0,6,0,0,6,0 | 2 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 48 hours; pH=6; n=6,0,6,0,0,6,0 | 1 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 48 hours; pH=7; n=6,0,6,0,0,6,0 | 2 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 48 hours; pH=8; n=6,0,6,0,0,6,0 | 1 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 72 hours; pH=5; n=6,0,6,0,0,6,0 | 1 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 72 hours; pH=6; n=6,0,6,0,0,6,0 | 3 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 72 hours; pH=7; n=6,0,6,0,0,6,0 | 2 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 72 hours; pH=8; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 72 hours; pH=9; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 48 hours; pH=5; n=5,0,0,5,0,0,6 | 2 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 24 hours; pH=5; n=5,0,0,5,0,0,6 | 2 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 48 hours; pH=7; n=5,0,0,5,0,0,6 | 1 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 24 hours; pH=6; n=5,0,0,5,0,0,6 | 2 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 24 hours; pH=9; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 24 hours; pH=7; n=5,0,0,5,0,0,6 | 1 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 72 hours; pH=6; n=5,0,0,5,0,0,6 | 3 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 24 hours; pH=8; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 72 hours; pH=8; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 72 hours; pH=7; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 72 hours; pH=9; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 72 hours; pH=5; n=5,0,0,5,0,0,6 | 2 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 8 hours; pH=5; n=5,0,0,5,0,0,6 | 1 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 8 hours; pH=6; n=5,0,0,5,0,0,6 | 1 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 48 hours; pH=9; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 8 hours; pH=7; n=5,0,0,5,0,0,6 | 3 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 48 hours; pH=8; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 8 hours; pH=8; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 48 hours; pH=6; n=5,0,0,5,0,0,6 | 2 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 8 hours; pH=9; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 72 hours; pH=5; n=3,0,0,0,6,0,0 | 2 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 24 hours; pH=5; n=6,6,0,0,6,0,0 | 1 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 48 hours; pH=5; n=6,6,0,0,6,0,0 | 4 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 24 hours; pH=7; n=6,6,0,0,6,0,0 | 2 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 8 hours; pH=8; n=6,6,0,0,6,0,0 | 1 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 48 hours; pH=9; n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 24 hours; pH=8; n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 8 hours; pH=7; n=6,6,0,0,6,0,0 | 2 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 72 hours; pH=8; n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 48 hours; pH=8; n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 8 hours; pH=6; n=6,6,0,0,6,0,0 | 3 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 48 hours; pH=6; n=6,6,0,0,6,0,0 | 2 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 24 hours; pH=9; n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 24 hours; pH=6; n=6,6,0,0,6,0,0 | 3 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 72 hours; pH=7; n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 8 hours; pH=5; n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 48 hours; pH=7; n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 72 hours; pH=6; n=3,0,0,0,6,0,0 | 4 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 8 hours; pH=9; n=6,6,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 1; 72 hours; pH=9; n=3,0,0,0,6,0,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 48 hours; pH=9; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 48 hours; pH=6; n=6,0,6,0,0,6,0 | 2 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 8 hours; pH=6; n=6,0,6,0,0,6,0 | 2 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 48 hours; pH=7; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 8 hours; pH=5; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 48 hours; pH=8; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 8 hours; pH=8; n=6,0,6,0,0,6,0 | 2 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 72 hours; pH=5; n=6,0,6,0,0,6,0 | 4 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 72 hours; pH=6; n=6,0,6,0,0,6,0 | 2 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 72 hours; pH=7; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 72 hours; pH=8; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 72 hours; pH=9; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 8 hours; pH=7; n=6,0,6,0,0,6,0 | 2 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 24 hours; pH=7; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 24 hours; pH=6; n=6,0,6,0,0,6,0 | 3 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 24 hours; pH=8; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 24 hours; pH=5; n=6,0,6,0,0,6,0 | 3 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 24 hours; pH=9; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 2; 8 hours; pH=9; n=6,0,6,0,0,6,0 | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | -Period 2; 48 hours; pH=5; n=6,0,6,0,0,6,0 | 4 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 48 hours; pH=7; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 48 hours; pH=5; n=5,0,0,5,0,0,6 | 2 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 8 hours; pH=7; n=5,0,0,5,0,0,6 | 1 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 48 hours; pH=8; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 72 hours; pH=8; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 8 hours; pH=6; n=5,0,0,5,0,0,6 | 3 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 48 hours; pH=9; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 8 hours; pH=5; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 72 hours; pH=9; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 72 hours; pH=5; n=5,0,0,5,0,0,6 | 3 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 72 hours; pH=6; n=5,0,0,5,0,0,6 | 3 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 72 hours; pH=7; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 24 hours; pH=8; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 24 hours; pH=7; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 24 hours; pH=6; n=5,0,0,5,0,0,6 | 3 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 24 hours; pH=9; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 24 hours; pH=5; n=5,0,0,5,0,0,6 | 3 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 8 hours; pH=9; n=5,0,0,5,0,0,6 | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 8 hours; pH=8; n=5,0,0,5,0,0,6 | 2 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Period 3; 48 hours; pH=6; n=5,0,0,5,0,0,6 | 4 Participants |
Primary
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Urine samples were taken for the assessment of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 to 6.0). Dipstick test results for pH were presented as number of participants having pH value as 5, 6, 7, 8 or 9.
Time frame: Day 2 (24 hours); Day 3 (48 hours); Days 4, 13 and 20 (72 hours); pre-dose on Days 7, 10, 11 and 17
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day7, pre-dose; pH=5; n=9,9,9,9 | 1 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day17, pre-dose; pH=6; n=6,9,8,0 | 1 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day 11, pre-dose; pH=7; n=6,9,9,0 | 3 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day4, 72 hours; pH=7; n=9,9,9,9 | 3 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day17, pre-dose; pH=5; n=6,9,8,0 | 1 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day 11, pre-dose; pH=8; n=6,9,9,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day3, 48 hours; pH=7; n=9,9,9,9 | 2 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day13, 72 hours; pH=9; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day 11, pre-dose; pH=9; n=6,9,9,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day3, 48 hours; pH=6; n=9,9,9,9 | 6 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day13, 72 hours; pH=8; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day13, 72 hours; pH=5; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day13, 72 hours; pH=7; n=3,0,0,9 | 1 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day13, 72 hours; pH=6; n=3,0,0,9 | 2 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day7, pre-dose; pH=6; n=9,9,9,9 | 3 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day4, 72 hours; pH=6; n=9,9,9,9 | 5 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day3, 48 hours; pH=5; n=9,9,9,9 | 1 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day2, 24 hours; pH=9; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day7, pre-dose; pH=7; n=9,9,9,9 | 5 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day4, 72 hours; pH=5; n=9,9,9,9 | 1 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day2, 24 hours; pH=8; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day2, 24 hours; pH=7; n=9,9,9,9 | 4 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day7, pre-dose; pH=8; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day4, 72 hours; pH=9; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day2, 24 hours; pH=6; n=9,9,9,9 | 4 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day2, 24 hours; pH=5; n=9,9,9,9 | 1 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day7, pre-dose; pH=9; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day4, 72 hours; pH=8; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day20, 72 hours; pH=9; n=6,9,7,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day20, 72 hours; pH=8; n=6,9,7,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day10, pre-dose; pH=5; n=3,0,0,9 | 1 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day20, 72 hours; pH=7; n=6,9,7,0 | 3 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day10, pre-dose; pH=6; n=3,0,0,9 | 2 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day20, 72 hours; pH=6; n=6,9,7,0 | 2 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day10, pre-dose; pH=7; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day3, 48 hours; pH=9; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day20, 72 hours; pH=5; n=6,9,7,0 | 1 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day10, pre-dose; pH=8; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day17, pre-dose; pH=9; n=6,9,8,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day10, pre-dose; pH=9; n=3,0,0,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day17, pre-dose; pH=8; n=6,9,8,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day 11, pre-dose; pH=5; n=6,9,9,0 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day3, 48 hours; pH=8; n=9,9,9,9 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day17, pre-dose; pH=7; n=6,9,8,0 | 4 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day 11, pre-dose; pH=6; n=6,9,9,0 | 3 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day2, 24 hours; pH=8; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day4, 72 hours; pH=8; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day4, 72 hours; pH=9; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day7, pre-dose; pH=5; n=9,9,9,9 | 3 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day7, pre-dose; pH=6; n=9,9,9,9 | 5 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day7, pre-dose; pH=7; n=9,9,9,9 | 1 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day7, pre-dose; pH=8; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day7, pre-dose; pH=9; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day10, pre-dose; pH=7; n=3,0,0,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day 11, pre-dose; pH=5; n=6,9,9,0 | 3 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day 11, pre-dose; pH=6; n=6,9,9,0 | 5 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day 11, pre-dose; pH=7; n=6,9,9,0 | 1 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day 11, pre-dose; pH=8; n=6,9,9,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day 11, pre-dose; pH=9; n=6,9,9,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day17, pre-dose; pH=5; n=6,9,8,0 | 1 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day17, pre-dose; pH=6; n=6,9,8,0 | 6 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day17, pre-dose; pH=7; n=6,9,8,0 | 2 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day17, pre-dose; pH=8; n=6,9,8,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day17, pre-dose; pH=9; n=6,9,8,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day20, 72 hours; pH=5; n=6,9,7,0 | 2 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day20, 72 hours; pH=6; n=6,9,7,0 | 5 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day20, 72 hours; pH=7; n=6,9,7,0 | 2 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day20, 72 hours; pH=8; n=6,9,7,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day20, 72 hours; pH=9; n=6,9,7,0 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day2, 24 hours; pH=5; n=9,9,9,9 | 2 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day2, 24 hours; pH=6; n=9,9,9,9 | 5 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day2, 24 hours; pH=7; n=9,9,9,9 | 2 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day2, 24 hours; pH=9; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day3, 48 hours; pH=5; n=9,9,9,9 | 4 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day3, 48 hours; pH=6; n=9,9,9,9 | 4 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day3, 48 hours; pH=7; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day3, 48 hours; pH=8; n=9,9,9,9 | 1 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day3, 48 hours; pH=9; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day4, 72 hours; pH=5; n=9,9,9,9 | 3 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day4, 72 hours; pH=6; n=9,9,9,9 | 3 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day4, 72 hours; pH=7; n=9,9,9,9 | 3 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day3, 48 hours; pH=9; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day4, 72 hours; pH=9; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day20, 72 hours; pH=8; n=6,9,7,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day7, pre-dose; pH=9; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day4, 72 hours; pH=6; n=9,9,9,9 | 5 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day20, 72 hours; pH=9; n=6,9,7,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day2, 24 hours; pH=5; n=9,9,9,9 | 1 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day7, pre-dose; pH=8; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day2, 24 hours; pH=6; n=9,9,9,9 | 5 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day2, 24 hours; pH=7; n=9,9,9,9 | 2 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day7, pre-dose; pH=7; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day4, 72 hours; pH=7; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day2, 24 hours; pH=8; n=9,9,9,9 | 1 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day2, 24 hours; pH=9; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day7, pre-dose; pH=6; n=9,9,9,9 | 5 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day4, 72 hours; pH=5; n=9,9,9,9 | 4 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day3, 48 hours; pH=5; n=9,9,9,9 | 4 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day3, 48 hours; pH=6; n=9,9,9,9 | 3 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day 11, pre-dose; pH=9; n=6,9,9,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day 11, pre-dose; pH=8; n=6,9,9,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day 11, pre-dose; pH=7; n=6,9,9,0 | 2 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day7, pre-dose; pH=5; n=9,9,9,9 | 4 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day17, pre-dose; pH=5; n=6,9,8,0 | 3 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day 11, pre-dose; pH=6; n=6,9,9,0 | 4 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day4, 72 hours; pH=8; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day17, pre-dose; pH=6; n=6,9,8,0 | 3 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day 11, pre-dose; pH=5; n=6,9,9,0 | 3 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day3, 48 hours; pH=7; n=9,9,9,9 | 2 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day17, pre-dose; pH=7; n=6,9,8,0 | 2 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day17, pre-dose; pH=8; n=6,9,8,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day17, pre-dose; pH=9; n=6,9,8,0 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day20, 72 hours; pH=5; n=6,9,7,0 | 4 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day3, 48 hours; pH=8; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day20, 72 hours; pH=6; n=6,9,7,0 | 3 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day20, 72 hours; pH=7; n=6,9,7,0 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day4, 72 hours; pH=7; n=9,9,9,9 | 1 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day7, pre-dose; pH=6; n=9,9,9,9 | 5 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day10, pre-dose; pH=6; n=3,0,0,9 | 4 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day4, 72 hours; pH=6; n=9,9,9,9 | 5 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day13, 72 hours; pH=8; n=3,0,0,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day10, pre-dose; pH=5; n=3,0,0,9 | 4 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day3, 48 hours; pH=8; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day2, 24 hours; pH=9; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day7, pre-dose; pH=9; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day4, 72 hours; pH=9; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day13, 72 hours; pH=9; n=3,0,0,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day10, pre-dose; pH=8; n=3,0,0,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day3, 48 hours; pH=5; n=9,9,9,9 | 3 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day7, pre-dose; pH=5; n=9,9,9,9 | 2 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day7, pre-dose; pH=8; n=9,9,9,9 | 1 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day10, pre-dose; pH=7; n=3,0,0,9 | 1 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day4, 72 hours; pH=5; n=9,9,9,9 | 3 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day2, 24 hours; pH=5; n=9,9,9,9 | 1 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day10, pre-dose; pH=9; n=3,0,0,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day3, 48 hours; pH=9; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day3, 48 hours; pH=6; n=9,9,9,9 | 6 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day2, 24 hours; pH=6; n=9,9,9,9 | 8 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day7, pre-dose; pH=7; n=9,9,9,9 | 1 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day4, 72 hours; pH=8; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day13, 72 hours; pH=6; n=3,0,0,9 | 2 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day2, 24 hours; pH=7; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day13, 72 hours; pH=5; n=3,0,0,9 | 4 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day13, 72 hours; pH=7; n=3,0,0,9 | 3 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day3, 48 hours; pH=7; n=9,9,9,9 | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Day2, 24 hours; pH=8; n=9,9,9,9 | 0 Participants |
Primary
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Urine samples were taken for the assessment of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 to 6.0). Dipstick test results for pH were presented as number of participants having pH value as 5, 6, 7, 8 or 9.
Time frame: 8 hours, 24 hours, 48 hours and 72 hours in Period 1 and Period 2
Population: Safety Population. All participants in Part C (11, 11) were included in the analysis; however, only 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 | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 48 hours; pH=5; n=6,6 | 2 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 8 hours; pH=6; n=6,6 | 1 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 8 hours; pH=7; n=6,6 | 3 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 8 hours; pH=8; n=6,6 | 2 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 8 hours; pH=9; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 24 hours; pH=5; n=6,6 | 2 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 24 hours; pH=6; n=6,6 | 3 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 24 hours; pH=7; n=6,6 | 1 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 24 hours; pH=8; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 24 hours; pH=9; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 8 hours; pH=5; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 48 hours; pH=6; n=6,6 | 3 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 48 hours; pH=7; n=6,6 | 1 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 48 hours; pH=8; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 48 hours; pH=9; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 72 hours; pH=5; n=6,6 | 3 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 72 hours; pH=6; n=6,6 | 3 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 72 hours; pH=7; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 72 hours; pH=8; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 72 hours; pH=9; n=6,6 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 8 hours; pH=5; n=5,5 | 1 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 8 hours; pH=6; n=5,5 | 1 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 8 hours; pH=7; n=5,5 | 3 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 8 hours; pH=8; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 8 hours; pH=9; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 24 hours; pH=5; n=5,5 | 3 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 24 hours; pH=6; n=5,5 | 1 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 24 hours; pH=7; n=5,5 | 1 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 24 hours; pH=8; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 24 hours; pH=9; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 48 hours; pH=5; n=5,5 | 3 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 48 hours; pH=6; n=5,5 | 2 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 48 hours; pH=7; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 48 hours; pH=8; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 48 hours; pH=9; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 72 hours; pH=5; n=5,5 | 2 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 72 hours; pH=6; n=5,5 | 3 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 72 hours; pH=7; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 72 hours; pH=8; n=5,5 | 0 Participants |
| Part A: Placebo | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 72 hours; pH=9; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 72 hours; pH=7; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 8 hours; pH=5; n=6,6 | 1 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 8 hours; pH=5; n=5,5 | 1 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 8 hours; pH=6; n=6,6 | 1 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 48 hours; pH=5; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 8 hours; pH=7; n=6,6 | 4 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 8 hours; pH=6; n=5,5 | 1 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 8 hours; pH=8; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 72 hours; pH=5; n=5,5 | 1 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 8 hours; pH=9; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 8 hours; pH=7; n=5,5 | 3 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 24 hours; pH=5; n=6,6 | 2 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 48 hours; pH=6; n=5,5 | 4 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 24 hours; pH=6; n=6,6 | 4 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 8 hours; pH=8; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 24 hours; pH=7; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 72 hours; pH=9; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 24 hours; pH=8; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 8 hours; pH=9; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 24 hours; pH=9; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 48 hours; pH=7; n=5,5 | 1 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 48 hours; pH=5; n=6,6 | 4 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 24 hours; pH=5; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 48 hours; pH=6; n=6,6 | 2 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 72 hours; pH=6; n=5,5 | 4 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 48 hours; pH=7; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 24 hours; pH=6; n=5,5 | 5 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 48 hours; pH=8; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 48 hours; pH=8; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 48 hours; pH=9; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 24 hours; pH=7; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 72 hours; pH=5; n=6,6 | 3 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 72 hours; pH=8; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 72 hours; pH=6; n=6,6 | 3 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 24 hours; pH=8; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 72 hours; pH=7; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 48 hours; pH=9; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 72 hours; pH=8; n=6,6 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 2, 24 hours; pH=9; n=5,5 | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Period 1, 72 hours; pH=9; n=6,6 | 0 Participants |
Primary
Number of Participants With Vital Signs of Potential Clinical Importance-Part A
Vital signs were measured in a supine position after five minutes of rest and included temperature, systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate and respiratory rate. The clinical concern range for the parameters included: SBP (low: \<85 millimeters of mercury \[mmHg\] and high: \>160 mmHg), DBP (low: \<45 mmHg and high: \>100 mmHg) and heart rate (low: \<40 beats per minute \[bpm\] and high: \>110 bpm). Number of participants with any vital signs of potential clinical importance is reported.
Time frame: Up to Day 40
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Placebo | Number of Participants With Vital Signs of Potential Clinical Importance-Part A | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Vital Signs of Potential Clinical Importance-Part A | 1 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Vital Signs of Potential Clinical Importance-Part A | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Vital Signs of Potential Clinical Importance-Part A | 0 Participants |
| Part A: GSK3439171A 60 mg | Number of Participants With Vital Signs of Potential Clinical Importance-Part A | 0 Participants |
| Part A: GSK3439171A 120 mg | Number of Participants With Vital Signs of Potential Clinical Importance-Part A | 0 Participants |
| Part A: GSK3439171A 180 mg | Number of Participants With Vital Signs of Potential Clinical Importance-Part A | 1 Participants |
Primary
Number of Participants With Vital Signs of Potential Clinical Importance-Part B
Vital signs were measured in a supine position after five minutes of rest and included temperature, SBP, DBP, heart rate and respiratory rate. The clinical concern range for the parameters included: SBP (low: \<85 mmHg and high: \>160 mmHg), DBP (low: \<45 mmHg and high: \>100 mmHg) and heart rate (low: \<40 bpm and high: \>110 bpm). Number of participants with any vital signs of potential clinical importance is reported.
Time frame: Up to Day 34
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Placebo | Number of Participants With Vital Signs of Potential Clinical Importance-Part B | 0 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Vital Signs of Potential Clinical Importance-Part B | 0 Participants |
| Part A: GSK3439171A 10 mg | Number of Participants With Vital Signs of Potential Clinical Importance-Part B | 0 Participants |
| Part A: GSK3439171A 30 mg | Number of Participants With Vital Signs of Potential Clinical Importance-Part B | 2 Participants |
Primary
Number of Participants With Vital Signs of Potential Clinical Importance-Part C
Vital signs were measured in a supine position after five minutes of rest and included temperature, SBP, DBP, heart rate and respiratory rate. The clinical concern range for the parameters included: SBP (low: \<85 mmHg and high: \>160 mmHg), DBP (low: \<45 mmHg and high: \>100 mmHg) and heart rate (low: \<40 bpm and high: \>110 bpm). Number of participants with any vital signs of potential clinical importance is reported.
Time frame: Up to Day 29
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Placebo | Number of Participants With Vital Signs of Potential Clinical Importance-Part C | 1 Participants |
| Part A: GSK3439171A 5 mg | Number of Participants With Vital Signs of Potential Clinical Importance-Part C | 0 Participants |
Primary
T1/2 of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 40 mg Only)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Day 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | T1/2 of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 40 mg Only) | 10.948 Hours | Geometric Coefficient of Variation 18.4 |
Primary
T1/2 of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Day 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | T1/2 of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg) | 13.253 Hours | Geometric Coefficient of Variation 23.8 |
| Part A: GSK3439171A 5 mg | T1/2 of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg) | 11.584 Hours | Geometric Coefficient of Variation 11.3 |
Primary
T1/2 of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | T1/2 of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | 11.233 Hours | Geometric Coefficient of Variation 44.6 |
| Part A: GSK3439171A 5 mg | T1/2 of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | 11.956 Hours | Geometric Coefficient of Variation 7.5 |
| Part A: GSK3439171A 10 mg | T1/2 of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | 11.183 Hours | Geometric Coefficient of Variation 17.8 |
| Part A: GSK3439171A 30 mg | T1/2 of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | 11.761 Hours | Geometric Coefficient of Variation 19.3 |
| Part A: GSK3439171A 60 mg | T1/2 of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | 11.076 Hours | Geometric Coefficient of Variation 22.1 |
Primary
T1/2 of GSK3439171A Following Single Dose-Part B (GSK3439171A 40 mg Only)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | T1/2 of GSK3439171A Following Single Dose-Part B (GSK3439171A 40 mg Only) | 11.908 Hours | Geometric Coefficient of Variation 18.9 |
Primary
T1/2 of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | T1/2 of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg) | 15.348 Hours | Geometric Coefficient of Variation 26.6 |
| Part A: GSK3439171A 5 mg | T1/2 of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg) | 14.275 Hours | Geometric Coefficient of Variation 32.4 |
Primary
Time to Maximum Observed Plasma Concentration (Tmax) of GSK3439171A Following Single Dose-Part A (GSK3439171A 5 mg Only)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours post-dose
Population: Pharmacokinetic Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo | Time to Maximum Observed Plasma Concentration (Tmax) of GSK3439171A Following Single Dose-Part A (GSK3439171A 5 mg Only) | 1.0000 Hours |
Primary
Tmax of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 40 mg Only)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Day 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)
Population: Pharmacokinetic Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo | Tmax of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 40 mg Only) | 3.0000 Hours |
Primary
Tmax of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Day 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo | Tmax of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg) | 3.0000 Hours |
| Part A: GSK3439171A 5 mg | Tmax of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg) | 2.0000 Hours |
Primary
Tmax of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose
Population: Pharmacokinetic Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo | Tmax of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | 0.9830 Hours |
| Part A: GSK3439171A 5 mg | Tmax of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | 1.5000 Hours |
| Part A: GSK3439171A 10 mg | Tmax of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | 1.7415 Hours |
| Part A: GSK3439171A 30 mg | Tmax of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | 4.0000 Hours |
| Part A: GSK3439171A 60 mg | Tmax of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | 2.9915 Hours |
Primary
Tmax of GSK3439171A Following Single Dose-Part B (GSK3439171A 40 mg Only)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)
Population: Pharmacokinetic Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo | Tmax of GSK3439171A Following Single Dose-Part B (GSK3439171A 40 mg Only) | 4.0000 Hours |
Primary
Tmax of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)
Population: Pharmacokinetic Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo | Tmax of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg) | 1.5000 Hours |
| Part A: GSK3439171A 5 mg | Tmax of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg) | 2.0000 Hours |
Secondary
AUC(0 to Inf) of GSK3439171A (Food Effect)-Part C
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | AUC(0 to Inf) of GSK3439171A (Food Effect)-Part C | 16458.9 Hours*nanograms per milliliter | Geometric Coefficient of Variation 27.4 |
| Part A: GSK3439171A 5 mg | AUC(0 to Inf) of GSK3439171A (Food Effect)-Part C | 14995.0 Hours*nanograms per milliliter | Geometric Coefficient of Variation 29.7 |
90% CI: [0.84, 1.04]
Secondary
AUC(0 to t) of GSK3439171A (Food Effect)-Part C
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | AUC(0 to t) of GSK3439171A (Food Effect)-Part C | 16263.2 Hours*nanograms per milliliter | Geometric Coefficient of Variation 27 |
| Part A: GSK3439171A 5 mg | AUC(0 to t) of GSK3439171A (Food Effect)-Part C | 14770.1 Hours*nanograms per milliliter | Geometric Coefficient of Variation 29 |
90% CI: [0.84, 1.03]
Secondary
Cmax for GSK3439171A (Food Effect)-Part C
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Cmax for GSK3439171A (Food Effect)-Part C | 1155.60 Nanograms per milliliter | Geometric Coefficient of Variation 16.3 |
| Part A: GSK3439171A 5 mg | Cmax for GSK3439171A (Food Effect)-Part C | 1025.45 Nanograms per milliliter | Geometric Coefficient of Variation 21.2 |
90% CI: [0.79, 1.01]
Secondary
Dose Proportionality of GSK3439171A Using AUC(0 to Inf) Following a Single Dose-Part A
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Dose proportionality was assessed using Power model with fixed effects of logarithm of treatment and participant as random effect. Slope and 90 % confidence interval for the slope are presented.
Time frame: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose
Population: Pharmacokinetic Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Placebo | Dose Proportionality of GSK3439171A Using AUC(0 to Inf) Following a Single Dose-Part A | 1.057 Slope of log dose |
Secondary
Dose Proportionality of GSK3439171A Using AUC(0 to Tau) Following Repeat Dose-Part B
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Dose proportionality was assessed using Power model with fixed effects of logarithm of treatment and participant as random effect. Slope and 90% confidence interval for the slope are presented.
Time frame: Days 10 and 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)
Population: Pharmacokinetic Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Placebo | Dose Proportionality of GSK3439171A Using AUC(0 to Tau) Following Repeat Dose-Part B | 0.966 Slope of log dose |
Secondary
Dose Proportionality of GSK3439171A Using AUC(0 to t) Following a Single Dose-Part A
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Dose proportionality was assessed using Power model with fixed effects of logarithm of treatment and participant as random effect. Slope and 90% confidence interval for the slope are presented.
Time frame: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose
Population: Pharmacokinetic Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Placebo | Dose Proportionality of GSK3439171A Using AUC(0 to t) Following a Single Dose-Part A | 1.068 Slope of log dose |
Secondary
Dose Proportionality of GSK3439171A Using Cmax Following a Single Dose-Part A
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Dose proportionality was assessed using Power model with fixed effects of logarithm of treatment and participant as random effect. Slope and 90% confidence interval for the slope are presented.
Time frame: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose
Population: Pharmacokinetic Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Placebo | Dose Proportionality of GSK3439171A Using Cmax Following a Single Dose-Part A | 0.944 Slope of log dose |
Secondary
Dose Proportionality of GSK3439171A Using Cmax Following Repeat Dose-Part B
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Dose proportionality was assessed using Power model with fixed effects of logarithm of treatment and participant as random effect. Slope and 90% confidence interval for the slope are presented.
Time frame: Days 10 and 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)
Population: Pharmacokinetic Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Placebo | Dose Proportionality of GSK3439171A Using Cmax Following Repeat Dose-Part B | 0.972 Slope of log dose |
Secondary
Observed Accumulation Ratio for AUC (AUC[Ro])-Part B (GSK3439171A 40 mg Only)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. AUC(Ro) was calculated as Day10 AUC(0 to tau) divided by Day 1 AUC (0 to tau). Analysis was performed using Mixed effect model with AUC (0 to tau) as the response variable. Treatment, visit and treatment-by-visit interaction are added as fixed effects and participant as random effect. Ratio and 90% confidence interval of the ratio is presented.
Time frame: Days 1 and 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)
Population: Pharmacokinetic Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Placebo | Observed Accumulation Ratio for AUC (AUC[Ro])-Part B (GSK3439171A 40 mg Only) | 1.49 Ratio |
Secondary
Observed Accumulation Ratio for AUC (AUC[Ro])-Part B (GSK3439171A 5 mg and 11 mg)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. AUC(Ro) was calculated as Day17 AUC(0 to tau) divided by Day 1 AUC (0 to tau). Analysis was performed using Mixed effect model with AUC (0 to tau) as the response variable. Treatment, visit and treatment-by-visit interaction are added as fixed effects and participant as random effect. Ratio and 90% confidence interval of the ratio is presented.
Time frame: Days 1 and 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Placebo | Observed Accumulation Ratio for AUC (AUC[Ro])-Part B (GSK3439171A 5 mg and 11 mg) | 1.39 Ratio |
| Part A: GSK3439171A 5 mg | Observed Accumulation Ratio for AUC (AUC[Ro])-Part B (GSK3439171A 5 mg and 11 mg) | 1.52 Ratio |
Secondary
Observed Accumulation Ratio for Cmax (RCmax)-Part B (GSK3439171A 40 mg Only)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. RCmax was calculated as Day10 Cmax divided by Day 1 Cmax. Analysis was performed using Mixed effect model with Cmax as the response variable. Treatment, visit and treatment-by-visit interaction are added as fixed effects and participant as random effect. Ratio and 90% confidence interval of the ratio is presented.
Time frame: Days 1 and 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)
Population: Pharmacokinetic Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Placebo | Observed Accumulation Ratio for Cmax (RCmax)-Part B (GSK3439171A 40 mg Only) | 1.49 Ratio |
Secondary
Observed Accumulation Ratio for Cmax (RCmax)-Part B (GSK3439171A 5 mg and 11 mg)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. RCmax was calculated as Day17 Cmax divided by Day 1 Cmax. Analysis was performed using Mixed effect model with Cmax as the response variable. Treatment, visit and treatment-by-visit interaction are added as fixed effects and participant as random effect. Ratio and 90% confidence interval of the ratio is presented.
Time frame: Days 1 and 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Placebo | Observed Accumulation Ratio for Cmax (RCmax)-Part B (GSK3439171A 5 mg and 11 mg) | 1.18 Ratio |
| Part A: GSK3439171A 5 mg | Observed Accumulation Ratio for Cmax (RCmax)-Part B (GSK3439171A 5 mg and 11 mg) | 1.28 Ratio |
Secondary
Steady State Accumulation Ratio (Rss)-Part B (GSK3439171A 40 mg Only)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Rss was calculated as Day 10 AUC(0-tau) divided by Day 1 AUC(0-inf). Analysis was performed using Mixed Effect Model, with AUC(0-tau) and AUC(0-inf) as the response variables. Treatment, visit, parameter and parameter-by-treatment-by-visit interaction are added as fixed effects and participant as random effect. Ratio and 90% confidence interval of the ratio is presented.
Time frame: Days 1 and 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)
Population: Pharmacokinetic Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Placebo | Steady State Accumulation Ratio (Rss)-Part B (GSK3439171A 40 mg Only) | 1.16 Ratio |
Secondary
Steady State Accumulation Ratio (Rss)-Part B (GSK3439171A 5 mg and 11 mg)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Rss was calculated as Day 17 AUC(0-tau) divided by Day 1 AUC(0-inf). Analysis was performed using Mixed Effect Model, with AUC(0-tau) and AUC(0-inf) as the response variables. Treatment, visit, parameter and parameter-by-treatment-by-visit interaction are added as fixed effects and participant as random effect. Ratio and 90% confidence interval of the ratio is presented.
Time frame: Days 1 and 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Placebo | Steady State Accumulation Ratio (Rss)-Part B (GSK3439171A 5 mg and 11 mg) | 1.07 Ratio |
| Part A: GSK3439171A 5 mg | Steady State Accumulation Ratio (Rss)-Part B (GSK3439171A 5 mg and 11 mg) | 1.21 Ratio |
Secondary
Steady State Assessment Using Trough Plasma Concentration at the End of Dosing Interval for Repeat Dose-Part B (GSK3439171A 40 mg Only)
Blood samples were collected at indicated time points for pharmacokinetic analysis. The slope estimate of the day effect was obtained from Mixed Effect Model, with visit as the fixed effect and participant as random effect. The analysis was done separately for each treatment. Variance Component covariance structure is used. The back transformed slope and 90% confidence interval for the slope is presented.
Time frame: pre-dose on Days 6, 7, 9 and 10
Population: Pharmacokinetic Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Placebo | Steady State Assessment Using Trough Plasma Concentration at the End of Dosing Interval for Repeat Dose-Part B (GSK3439171A 40 mg Only) | 1.003 Slope |
Secondary
Steady State Assessment Using Trough Plasma Concentration at the End of Dosing Interval for Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg)
Blood samples were collected at indicated time points for pharmacokinetic analysis. The slope estimate of the day effect was obtained from Mixed Effect Model, with visit as the fixed effect and participant as random effect. The analysis was done separately for each treatment. Variance Component covariance structure was used. The back transformed slope and 90% confidence interval for the slope is presented.
Time frame: pre-dose on Days 6, 7, 9, 10, 11, 15, 16 and 17
Population: Pharmacokinetic Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Placebo | Steady State Assessment Using Trough Plasma Concentration at the End of Dosing Interval for Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg) | 1.000 Slope |
| Part A: GSK3439171A 5 mg | Steady State Assessment Using Trough Plasma Concentration at the End of Dosing Interval for Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg) | 0.997 Slope |
Secondary
T1/2 for GSK3439171A-Part C
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | T1/2 for GSK3439171A-Part C | 10.820 Hours | Geometric Coefficient of Variation 13.7 |
| Part A: GSK3439171A 5 mg | T1/2 for GSK3439171A-Part C | 11.679 Hours | Geometric Coefficient of Variation 19.7 |
Secondary
Tmax for GSK3439171A-Part C
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose
Population: Pharmacokinetic Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo | Tmax for GSK3439171A-Part C | 3.0000 Hours |
| Part A: GSK3439171A 5 mg | Tmax for GSK3439171A-Part C | 4.0000 Hours |
Secondary
Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9, 10, 11, 15, 16 and 17-Part B (GSK3439171A 5 mg and 11 mg)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose on Days 6, 7, 9, 10, 11, 15, 16 and 17
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9, 10, 11, 15, 16 and 17-Part B (GSK3439171A 5 mg and 11 mg) | pre-dose Day 6; n=9, 9 | 27.3206 Nanograms per milliliter | Geometric Coefficient of Variation 42.3 |
| Part A: Placebo | Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9, 10, 11, 15, 16 and 17-Part B (GSK3439171A 5 mg and 11 mg) | pre-dose Day 7; n=9, 9 | 29.5449 Nanograms per milliliter | Geometric Coefficient of Variation 44.5 |
| Part A: Placebo | Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9, 10, 11, 15, 16 and 17-Part B (GSK3439171A 5 mg and 11 mg) | pre-dose Day 9; n=9, 9 | 28.5910 Nanograms per milliliter | Geometric Coefficient of Variation 46 |
| Part A: Placebo | Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9, 10, 11, 15, 16 and 17-Part B (GSK3439171A 5 mg and 11 mg) | pre-dose Day 10; n=9, 9 | 29.2380 Nanograms per milliliter | Geometric Coefficient of Variation 44.1 |
| Part A: Placebo | Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9, 10, 11, 15, 16 and 17-Part B (GSK3439171A 5 mg and 11 mg) | pre-dose Day 11; n=9, 9 | 28.8443 Nanograms per milliliter | Geometric Coefficient of Variation 42.8 |
| Part A: Placebo | Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9, 10, 11, 15, 16 and 17-Part B (GSK3439171A 5 mg and 11 mg) | pre-dose Day 15; n=9, 9 | 26.2039 Nanograms per milliliter | Geometric Coefficient of Variation 58 |
| Part A: Placebo | Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9, 10, 11, 15, 16 and 17-Part B (GSK3439171A 5 mg and 11 mg) | pre-dose Day 16; n=9, 9 | 27.4434 Nanograms per milliliter | Geometric Coefficient of Variation 51.3 |
| Part A: Placebo | Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9, 10, 11, 15, 16 and 17-Part B (GSK3439171A 5 mg and 11 mg) | pre-dose Day 17; n=9, 7 | 28.5046 Nanograms per milliliter | Geometric Coefficient of Variation 47.3 |
| Part A: GSK3439171A 5 mg | Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9, 10, 11, 15, 16 and 17-Part B (GSK3439171A 5 mg and 11 mg) | pre-dose Day 17; n=9, 7 | 48.0658 Nanograms per milliliter | Geometric Coefficient of Variation 52.9 |
| Part A: GSK3439171A 5 mg | Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9, 10, 11, 15, 16 and 17-Part B (GSK3439171A 5 mg and 11 mg) | pre-dose Day 6; n=9, 9 | 35.6842 Nanograms per milliliter | Geometric Coefficient of Variation 55.9 |
| Part A: GSK3439171A 5 mg | Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9, 10, 11, 15, 16 and 17-Part B (GSK3439171A 5 mg and 11 mg) | pre-dose Day 11; n=9, 9 | 30.4420 Nanograms per milliliter | Geometric Coefficient of Variation 105.7 |
| Part A: GSK3439171A 5 mg | Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9, 10, 11, 15, 16 and 17-Part B (GSK3439171A 5 mg and 11 mg) | pre-dose Day 7; n=9, 9 | 41.6334 Nanograms per milliliter | Geometric Coefficient of Variation 61.5 |
| Part A: GSK3439171A 5 mg | Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9, 10, 11, 15, 16 and 17-Part B (GSK3439171A 5 mg and 11 mg) | pre-dose Day 16; n=9, 9 | 24.9684 Nanograms per milliliter | Geometric Coefficient of Variation 362.7 |
| Part A: GSK3439171A 5 mg | Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9, 10, 11, 15, 16 and 17-Part B (GSK3439171A 5 mg and 11 mg) | pre-dose Day 9; n=9, 9 | 38.2703 Nanograms per milliliter | Geometric Coefficient of Variation 65.3 |
| Part A: GSK3439171A 5 mg | Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9, 10, 11, 15, 16 and 17-Part B (GSK3439171A 5 mg and 11 mg) | pre-dose Day 15; n=9, 9 | 30.8384 Nanograms per milliliter | Geometric Coefficient of Variation 247.3 |
| Part A: GSK3439171A 5 mg | Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9, 10, 11, 15, 16 and 17-Part B (GSK3439171A 5 mg and 11 mg) | pre-dose Day 10; n=9, 9 | 35.4203 Nanograms per milliliter | Geometric Coefficient of Variation 76.8 |
Secondary
Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9 and 10-Part B (GSK3439171A 40 mg Only)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose on Days 6, 7, 9 and 10
Population: Pharmacokinetic Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9 and 10-Part B (GSK3439171A 40 mg Only) | pre-dose Day 6 | 184.1428 Nanograms per milliliter | Geometric Coefficient of Variation 40.4 |
| Part A: Placebo | Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9 and 10-Part B (GSK3439171A 40 mg Only) | pre-dose Day 7 | 209.1741 Nanograms per milliliter | Geometric Coefficient of Variation 37.8 |
| Part A: Placebo | Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9 and 10-Part B (GSK3439171A 40 mg Only) | pre-dose Day 9 | 211.2785 Nanograms per milliliter | Geometric Coefficient of Variation 37 |
| Part A: Placebo | Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9 and 10-Part B (GSK3439171A 40 mg Only) | pre-dose Day 10 | 215.1369 Nanograms per milliliter | Geometric Coefficient of Variation 36.9 |