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This is an open-label, 2 part, single-dose and crossover study conducted to assess the relative bioavailability of a tablet compared to a capsule of GSK3640254 and to assess the effect of food on the GSK3640254 tablet in healthy participants. This study will also evaluate the effect of food (fasted, moderate fat meal, and high fat meal) on the pharmacokinetics of the GSK3640254 mesylate tablet formulation. In Part 1, participants will be randomly assigned to 1 of 2 treatment sequences (AB or BA) in two sequential treatment periods; and in Part 2, participants will be randomly assigned to 1 of 3 treatment sequences (CDE, DEC, or ECD) in three sequential treatment periods. Participants will be randomized to receive a single dose of GSK3640254 200 milligram (mg) capsules under moderate fat conditions and GSK3640254 200 mg tablets under moderate fat, fasted and high fat conditions in each treatment period. Approximately 30 participants will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Treatment AB | Experimental | Participants will receive a single dose of GSK3640254 200 mg (Treatment A- Reference), capsules, orally under moderate fat conditions on Day 1 in first intervention period; followed by GSK3640254 200 mg (Treatment B- Test), tablets, orally under moderate fat conditions on Day 1 in second intervention period. There will be at least 7 days wash out period between each dose of study intervention. |
|
| Part 1: Treatment BA | Experimental | Participants will receive a single dose of GSK3640254 200 mg (Treatment B- Test), tablets, orally under moderate fat conditions on Day 1 in first intervention period; followed by GSK3640254 200 mg (Treatment A- Reference), capsules, orally under moderate fat conditions on Day 1 in second intervention period. There will be at least 7 days wash out period between each dose of study intervention. |
|
| Part 2: Treatment CDE | Experimental | Participants will receive a single dose of GSK3640254 200 mg (Treatment C- Test), tablets, orally under moderate fat conditions on Day 1 in first intervention period; followed by GSK3640254 200 mg (Treatment D- Reference), tablets, orally under fasted conditions on Day 1 in second intervention period; followed by GSK3640254 200 mg (Treatment E- Test), tablets, orally under high fat conditions on Day 1 in third intervention period. There will be at least 7 days wash out period between each dose of study intervention. |
|
| Part 2: Treatment DEC |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK3640254 Tablet | Drug | GSK3640254 tablets will contain mesylate salt with a unit dose of 100 mg (2x100 mg) and will be administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0 to Inf]) for GSK3640254-Part 1 | Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis. PK parameters were calculated using standard non-compartmental analysis. | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
| Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Time t (AUC[0 to t]) for GSK3640254-Part 1 | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
| Maximum Observed Concentration (Cmax) for GSK3640254-Part 1 | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
| Time of Maximum Observed Concentration for GSK3640254-Part 1 | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
| AUC(0 to Inf) for GSK3640254-Part 2 | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 | 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 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 or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | ViiV Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Austin | Texas | 78744 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34995417 | Derived | Johnson M, Pene Dumitrescu T, Joshi SR, Mathew A, Bainbridge V, Zhan J, Lataillade M. Relative Bioavailability and Food Effect of GSK3640254 Tablet and Capsule Formulations in Healthy Participants. Clin Pharmacol Drug Dev. 2022 May;11(5):632-639. doi: 10.1002/cpdd.1051. Epub 2022 Jan 7. |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
A total of 39 participants were enrolled in Part 1 (18 participants) and Part 2 (21 participants) of the study.
This was a 2-part, randomized, single dose cross-over study conducted at a single center in the United States to assess the relative bioavailability and food effect of GSK3640254 tablet and capsule formulations in healthy participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Treatment Sequence AB | Participants were administered a single dose of GSK3640254 200 milligram (mg) capsules (Treatment A-reference), orally under moderate fat conditions on Day 1 in Period 1, followed by GSK3640254 200 mg tablets (Treatment B- test), orally under moderate fat conditions on Day 1 in Period 2. There was a wash out period of at least 7 days between each dose of study intervention. |
| FG001 | Part 1: Treatment Sequence BA | Participants were administered a single dose of GSK3640254 200 mg tablets (Treatment B-test), orally under moderate fat conditions on Day 1 in Period 1, followed by GSK3640254 200 mg capsules (Treatment A-reference), orally under moderate fat conditions on Day 1 in Period 2. There was a wash out period of at least 7 days between each dose of study intervention. |
| FG002 | Part 2: Treatment Sequence CDE | Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 1, followed by GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 2, followed by GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention. |
| FG003 | Part 2: Treatment Sequence DEC | Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 1, followed by GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 2, followed by GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention. |
| FG004 | Part 2: Treatment Sequence ECD | Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 1; followed by GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 2; followed by GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 Period 1 (Day 1) |
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| Part 1 Period 2 (Up to Day 5) |
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| Part 2 Period 1 (Day 1) |
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| Part 2 Period 2 (Day 1) |
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| Part 2 Period 3 (Up to Day 5) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Treatment Sequence AB | Participants were administered a single dose of GSK3640254 200 milligram (mg) capsules (Treatment A-reference), orally under moderate fat conditions on Day 1 in Period 1, followed by GSK3640254 200 mg tablets (Treatment B- test), orally under moderate fat conditions on Day 1 in Period 2. There was a wash out period of at least 7 days between each dose of study intervention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0 to Inf]) for GSK3640254-Part 1 | Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis. PK parameters were calculated using standard non-compartmental analysis. | PK Parameter Population comprised of all participants who underwent plasma PK sampling and had evaluable PK parameters estimated. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per milliliter | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
|
Up to Day 12 for Part 1 and up to Day 19 for Part 2
AEs and SAEs were collected in the Safety Population which comprised of all participants who received at least 1 dose of study medication. Data is presented treatment-wise.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: GSK3640254 200 mg Capsules | Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye irritation | Eye disorders | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | ViiV Healthcare | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 20, 2020 | Jan 31, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 16, 2020 | Jan 31, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C000723722 | GSK3640254 |
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Eligible participants will be randomly assigned to 1 of 2 treatment sequences (AB or BA) in Part 1 and 1 of 3 treatment sequences (CDE, DEC, or ECD) in Part 2.
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This is an open label study.
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Participants will receive a single dose of GSK3640254 200 mg (Treatment D- Reference), tablets, orally under fasted conditions on Day 1 in first intervention period; followed by GSK3640254 200 mg (Treatment E- Test), tablets, orally under high fat conditions on Day 1 in second intervention period; followed by GSK3640254 200 mg (Treatment C- Test), tablets, orally under moderate fat conditions on Day 1 in third intervention period. There will be at least 7 days wash out period between each dose of study intervention. |
|
| Part 2: Treatment ECD | Experimental | Participants will receive a single dose of GSK3640254 200 mg (Treatment E- Test), tablets, orally under high fat conditions on Day 1 in first intervention period; followed by GSK3640254 200 mg (Treatment C- Test), tablets, orally under moderate fat conditions on Day 1 in second intervention period; followed by GSK3640254 200 mg (Treatment D- Reference), tablets, orally under fasted conditions on Day 1 in third intervention period. There will be at least 7 days wash out period between each dose of study intervention. |
|
| GSK3640254 Capsule | Drug | GSK3640254 capsules will contain mesylate salt with a unit dose of 100 mg (2x100 mg) and will be administered orally. |
|
| AUC(0 to t) for GSK3640254-Part 2 |
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. |
| pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
| Cmax for GSK3640254-Part 2 | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
| Time of Maximum Observed Concentration for GSK3640254-Part 2 | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
| Up to Day 12 |
| Number of Participants With AEs and SAEs-Part 2 | 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 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 or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. | Up to Day 19 |
| Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets. | Baseline (Day -1), Day 2 and Day 5 |
| Absolute Values for Erythrocytes Count-Part 1 | Blood samples were collected for the assessment of following hematology parameter: erythrocytes count. | Baseline (Day -1), Day 2 and Day 5 |
| Absolute Values for Hemoglobin-Part 1 | Blood samples were collected for the assessment of following hematology parameter: hemoglobin. | Baseline (Day -1), Day 2 and Day 5 |
| Absolute Values for Hematocrit-Part 1 | Blood samples were collected for the assessment of following hematology parameter: hematocrit. | Baseline (Day -1), Day 2 and Day 5 |
| Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 1 | Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume. | Baseline (Day -1), Day 2 and Day 5 |
| Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 1 | Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin. | Baseline (Day -1), Day 2 and Day 5 |
| Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets. | Baseline (Day -1), Day 2 and Day 5 |
| Absolute Values for Erythrocytes Count-Part 2 | Blood samples were collected for the assessment of following hematology parameter: erythrocytes count. | Baseline (Day -1), Day 2 and Day 5 |
| Absolute Values for Hemoglobin-Part 2 | Blood samples were collected for the assessment of following hematology parameter: hemoglobin. | Baseline (Day -1), Day 2 and Day 5 |
| Absolute Values for Hematocrit-Part 2 | Blood samples were collected for the assessment of following hematology parameter: hematocrit. | Baseline (Day -1), Day 2 and Day 5 |
| Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 2 | Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume. | Baseline (Day -1), Day 2 and Day 5 |
| Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 2 | Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin. | Baseline (Day -1), Day 2 and Day 5 |
| Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 2 and Day 5 |
| Change From Baseline in Erythrocytes Count-Part 1 | Blood samples were collected for the assessment of following hematology parameter: erythrocytes count. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 2 and Day 5 |
| Change From Baseline in Hemoglobin-Part 1 | Blood samples were collected for the assessment of following hematology parameter: hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 2 and Day 5 |
| Change From Baseline in Hematocrit-Part 1 | Blood samples were collected for the assessment of following hematology parameter: hematocrit. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 2 and Day 5 |
| Change From Baseline in Erythrocyte Mean Corpuscular Volume-Part 1 | Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 2 and Day 5 |
| Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin-Part 1 | Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 2 and Day 5 |
| Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 2 and Day 5 |
| Change From Baseline in Erythrocytes Count-Part 2 | Blood samples were collected for the assessment of following hematology parameter: erythrocytes count. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 2 and Day 5 |
| Change From Baseline in Hemoglobin-Part 2 | Blood samples were collected for the assessment of following hematology parameter: hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 2 and Day 5 |
| Change From Baseline in Hematocrit-Part 2 | Blood samples were collected for the assessment of following hematology parameter: hematocrit. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 2 and Day 5 |
| Change From Baseline in Erythrocyte Mean Corpuscular Volume-Part 2 | Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 2 and Day 5 |
| Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin-Part 2 | Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 2 and Day 5 |
| Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate. | Baseline (Day -1), Day 2 and Day 5 |
| Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide. | Baseline (Day -1), Day 2 and Day 5 |
| Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH. | Baseline (Day -1), Day 2 and Day 5 |
| Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein. | Baseline (Day -1), Day 2 and Day 5 |
| Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 1 | Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase. | Baseline (Day -1), Day 2 and Day 5 |
| Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate. | Baseline (Day -1), Day 2 and Day 5 |
| Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide. | Baseline (Day -1), Day 2 and Day 5 |
| Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH. | Baseline (Day -1), Day 2 and Day 5 |
| Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein. | Baseline (Day -1), Day 2 and Day 5 |
| Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2 | Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase. | Baseline (Day -1), Day 2 and Day 5 |
| Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 2 and Day 5 |
| Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 2 and Day 5 |
| Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1 | Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 2 and Day 5 |
| Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 2 and Day 5 |
| Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 1 | Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 2 and Day 5 |
| Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 2 and Day 5 |
| Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 2 and Day 5 |
| Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 2 and Day 5 |
| Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 2 and Day 5 |
| Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 2 | Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 2 and Day 5 |
| Absolute Values for Urine Parameter: Specific Gravity-Part 1 | Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. | Baseline (Day -1), Day 2 and Day 5 |
| Absolute Values for Urine Parameter: Urobilinogen-Part 1 | Urine samples were collected at indicated time points for the assessment of urine urobilinogen. | Baseline (Day -1), Day 2 and Day 5 |
| Absolute Values for Urine Parameter: Potential of Hydrogen (pH)-Part 1 | Urine samples were collected at indicated time points 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 acidic pH (5.0 - 6.0). | Baseline (Day -1), Day 2 and Day 5 |
| Absolute Values for Urine Parameter: Specific Gravity-Part 2 | Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. | Baseline (Day -1), Day 2 and Day 5 |
| Absolute Values for Urine Parameter: Urobilinogen-Part 2 | Urine samples were collected at indicated time points for the assessment of urine urobilinogen. | Baseline (Day -1), Day 2 and Day 5 |
| Absolute Values for Urine Parameter: pH-Part 2 | Urine samples were collected at indicated time points 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 acidic pH (5.0 - 6.0). | Baseline (Day -1), Day 2 and Day 5 |
| Change From Baseline in Urine Parameter: Specific Gravity-Part 1 | Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 2 and Day 5 |
| Change From Baseline in Urine Parameter: Urobilinogen-Part 1 | Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 2 and Day 5 |
| Change From Baseline in Urine Parameter: pH-Part 1 | Urine samples were collected at indicated time points 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 acidic pH (5.0 - 6.0). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 2 and Day 5 |
| Change From Baseline in Urine Parameter: Specific Gravity-Part 2 | Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 2 and Day 5 |
| Change From Baseline in Urine Parameter: Urobilinogen-Part 2 | Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 2 and Day 5 |
| Change From Baseline in Urine Parameter: pH-Part 2 | Urine samples were collected at indicated time points 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 acidic pH (5.0 - 6.0). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 2 and Day 5 |
| Number of Participants With Abnormal Urine Dipstick Results-Part 1 | Urine samples were collected at indicated time points for the assessment of following urine parameters: bilirubin, glucose, ketones, nitrite, leukocyte esterase, occult blood and protein by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Only parameters and time points with abnormal results have been presented. | Day 2 and Day 5 |
| Number of Participants With Abnormal Urine Dipstick Results-Part 2 | Urine samples were collected at indicated time points for the assessment of following urine parameters: bilirubin, glucose, ketones, nitrite, leukocyte esterase, occult blood and protein by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Only parameters and time points with abnormal results have been presented. | Day 2 and Day 5 |
| Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals. | Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5 |
| Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals. | Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5 |
| Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1 | Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5 |
| Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5 |
| Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1 | Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
| Absolute Values for Vital Sign: Pulse Rate-Part 1 | Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
| Absolute Values for Vital Sign: Respiratory Rate-Part 1 | Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
| Absolute Values for Vital Sign: Temperature-Part 1 | Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
| Absolute Values for Vital Signs: DBP and SBP-Part 2 | Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
| Absolute Values for Vital Sign: Pulse Rate-Part 2 | Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
| Absolute Values for Vital Sign: Respiratory Rate-Part 2 | Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
| Absolute Values for Vital Sign: Temperature-Part 2 | Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
| Change From Baseline in Vital Signs: SBP and DBP-Part 1 | Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
| Change From Baseline in Vital Sign: Pulse Rate-Part 1 | Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
| Change From Baseline in Vital Sign: Respiratory Rate-Part 1 | Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
| Change From Baseline in Vital Sign: Temperature-Part 1 | Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
| Change From Baseline in Vital Signs: SBP and DBP-Part 2 | Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
| Change From Baseline in Vital Sign: Pulse Rate-Part 2 | Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
| Change From Baseline in Vital Sign: Respiratory Rate-Part 2 | Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
| Change From Baseline in Vital Sign: Temperature-Part 2 | Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
| Lag Time for Absorption (Tlag) for GSK3640254-Part 1 | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
| Apparent Terminal Phase Half-life (t1/2) for GSK3640254-Part 1 | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
| Apparent Oral Clearance (CL/F) for GSK3640254-Part 1 | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
| Apparent Volume of Distribution (Vz/F) for GSK3640254-Part 1 | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
| Plasma Concentration of GSK3640254-Part 1 | Blood samples were collected at indicated time points for PK analysis. | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
| Tlag for GSK3640254-Part 2 | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
| T1/2 for GSK3640254-Part 2 | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
| CL/F for GSK3640254-Part 2 | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
| Vz/F for GSK3640254-Part 2 | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
| Plasma Concentration of GSK3640254-Part 2 | Blood samples were collected at indicated time points for PK analysis. | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 | Part 1: Treatment Sequence BA | Participants were administered a single dose of GSK3640254 200 mg tablets (Treatment B-test), orally under moderate fat conditions on Day 1 in Period 1, followed by GSK3640254 200 mg capsules (Treatment A-reference), orally under moderate fat conditions on Day 1 in Period 2. There was a wash out period of at least 7 days between each dose of study intervention. |
| BG002 | Part 2: Treatment Sequence CDE | Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 1, followed by GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 2, followed by GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention. |
| BG003 | Part 2: Treatment Sequence DEC | Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 1, followed by GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 2, followed by GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention. |
| BG004 | Part 2: Treatment Sequence ECD | Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 1; followed by GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 2; followed by GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention. |
| BG005 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| OG001 |
| Part 1: GSK3640254 200 mg Tablets |
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2. |
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| Primary | Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Time t (AUC[0 to t]) for GSK3640254-Part 1 | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per milliliter | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
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| Primary | Maximum Observed Concentration (Cmax) for GSK3640254-Part 1 | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
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| Primary | Time of Maximum Observed Concentration for GSK3640254-Part 1 | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. | PK Parameter Population | Posted | Median | Full Range | Hours | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
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| Primary | AUC(0 to Inf) for GSK3640254-Part 2 | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*micrograms per milliliter | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
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| Primary | AUC(0 to t) for GSK3640254-Part 2 | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*micrograms per milliliter | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
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| Primary | Cmax for GSK3640254-Part 2 | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
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| Primary | Time of Maximum Observed Concentration for GSK3640254-Part 2 | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | Posted | Median | Full Range | Hours | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
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| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 | 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 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 or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. | Safety Population comprised of all participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Up to Day 12 |
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| Secondary | Number of Participants With AEs and SAEs-Part 2 | 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 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 or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. | Safety Population | Posted | Count of Participants | Participants | Up to Day 19 |
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| Secondary | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | 10^9 cells per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Absolute Values for Erythrocytes Count-Part 1 | Blood samples were collected for the assessment of following hematology parameter: erythrocytes count. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | 10^12 cells per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Absolute Values for Hemoglobin-Part 1 | Blood samples were collected for the assessment of following hematology parameter: hemoglobin. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Absolute Values for Hematocrit-Part 1 | Blood samples were collected for the assessment of following hematology parameter: hematocrit. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 1 | Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Femtoliters | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 1 | Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Picograms | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | 10^9 cells per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Absolute Values for Erythrocytes Count-Part 2 | Blood samples were collected for the assessment of following hematology parameter: erythrocytes count. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | 10^12 cells per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Absolute Values for Hemoglobin-Part 2 | Blood samples were collected for the assessment of following hematology parameter: hemoglobin. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Absolute Values for Hematocrit-Part 2 | Blood samples were collected for the assessment of following hematology parameter: hematocrit. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 2 | Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Femtoliters | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 2 | Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Picograms | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | 10^9 cells per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Change From Baseline in Erythrocytes Count-Part 1 | Blood samples were collected for the assessment of following hematology parameter: erythrocytes count. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | 10^12 cells per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Change From Baseline in Hemoglobin-Part 1 | Blood samples were collected for the assessment of following hematology parameter: hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Change From Baseline in Hematocrit-Part 1 | Blood samples were collected for the assessment of following hematology parameter: hematocrit. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Change From Baseline in Erythrocyte Mean Corpuscular Volume-Part 1 | Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Femtoliters | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin-Part 1 | Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Picograms | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | 10^9 cells per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Change From Baseline in Erythrocytes Count-Part 2 | Blood samples were collected for the assessment of following hematology parameter: erythrocytes count. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | 10^12 cells per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Change From Baseline in Hemoglobin-Part 2 | Blood samples were collected for the assessment of following hematology parameter: hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Change From Baseline in Hematocrit-Part 2 | Blood samples were collected for the assessment of following hematology parameter: hematocrit. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Change From Baseline in Erythrocyte Mean Corpuscular Volume-Part 2 | Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Femtoliters | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin-Part 2 | Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Picograms | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Millimoles per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | International units per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 1 | Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Units per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Millimoles per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | International units per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2 | Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Units per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Millimoles per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1 | Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | International units per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 1 | Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Units per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Millimoles per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | International units per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 2 | Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Units per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Absolute Values for Urine Parameter: Specific Gravity-Part 1 | Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Ratio | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Absolute Values for Urine Parameter: Urobilinogen-Part 1 | Urine samples were collected at indicated time points for the assessment of urine urobilinogen. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Absolute Values for Urine Parameter: Potential of Hydrogen (pH)-Part 1 | Urine samples were collected at indicated time points 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 acidic pH (5.0 - 6.0). | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | pH | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Absolute Values for Urine Parameter: Specific Gravity-Part 2 | Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Ratio | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Absolute Values for Urine Parameter: Urobilinogen-Part 2 | Urine samples were collected at indicated time points for the assessment of urine urobilinogen. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Absolute Values for Urine Parameter: pH-Part 2 | Urine samples were collected at indicated time points 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 acidic pH (5.0 - 6.0). | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | pH | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Change From Baseline in Urine Parameter: Specific Gravity-Part 1 | Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Ratio | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Change From Baseline in Urine Parameter: Urobilinogen-Part 1 | Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Change From Baseline in Urine Parameter: pH-Part 1 | Urine samples were collected at indicated time points 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 acidic pH (5.0 - 6.0). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | pH | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Change From Baseline in Urine Parameter: Specific Gravity-Part 2 | Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Ratio | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Change From Baseline in Urine Parameter: Urobilinogen-Part 2 | Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Change From Baseline in Urine Parameter: pH-Part 2 | Urine samples were collected at indicated time points 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 acidic pH (5.0 - 6.0). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | pH | Baseline (Day -1), Day 2 and Day 5 |
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| Secondary | Number of Participants With Abnormal Urine Dipstick Results-Part 1 | Urine samples were collected at indicated time points for the assessment of following urine parameters: bilirubin, glucose, ketones, nitrite, leukocyte esterase, occult blood and protein by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Only parameters and time points with abnormal results have been presented. | Safety Population | Posted | Count of Participants | Participants | Day 2 and Day 5 |
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| Secondary | Number of Participants With Abnormal Urine Dipstick Results-Part 2 | Urine samples were collected at indicated time points for the assessment of following urine parameters: bilirubin, glucose, ketones, nitrite, leukocyte esterase, occult blood and protein by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Only parameters and time points with abnormal results have been presented. | Safety Population | Posted | Count of Participants | Participants | Day 2 and Day 5 |
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| Secondary | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Milliseconds | Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5 |
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| Secondary | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Milliseconds | Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5 |
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| Secondary | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1 | Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Milliseconds | Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5 |
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| Secondary | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Milliseconds | Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5 |
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| Secondary | Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1 | Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. | Safety Population | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
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| Secondary | Absolute Values for Vital Sign: Pulse Rate-Part 1 | Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. | Safety Population | Posted | Mean | Standard Deviation | Beats per minute | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
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| Secondary | Absolute Values for Vital Sign: Respiratory Rate-Part 1 | Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Breaths per minute | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
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| Secondary | Absolute Values for Vital Sign: Temperature-Part 1 | Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. | Safety Population | Posted | Mean | Standard Deviation | Degrees Celsius | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
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| Secondary | Absolute Values for Vital Signs: DBP and SBP-Part 2 | Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. | Safety Population | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
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| Secondary | Absolute Values for Vital Sign: Pulse Rate-Part 2 | Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. | Safety Population | Posted | Mean | Standard Deviation | Beats per minute | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
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| Secondary | Absolute Values for Vital Sign: Respiratory Rate-Part 2 | Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. | Safety Population | Posted | Mean | Standard Deviation | Breaths per minute | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
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| Secondary | Absolute Values for Vital Sign: Temperature-Part 2 | Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. | Safety Population | Posted | Mean | Standard Deviation | Degrees Celsius | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
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| Secondary | Change From Baseline in Vital Signs: SBP and DBP-Part 1 | Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
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| Secondary | Change From Baseline in Vital Sign: Pulse Rate-Part 1 | Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. | Safety Population | Posted | Mean | Standard Deviation | Beats per minute | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
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|
| Secondary | Change From Baseline in Vital Sign: Respiratory Rate-Part 1 | Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | Mean | Standard Deviation | Breaths per minute | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
|
|
|
| Secondary | Change From Baseline in Vital Sign: Temperature-Part 1 | Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Degrees Celsius | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
|
|
|
| Secondary | Change From Baseline in Vital Signs: SBP and DBP-Part 2 | Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
|
|
|
| Secondary | Change From Baseline in Vital Sign: Pulse Rate-Part 2 | Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Beats per minute | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
|
|
|
| Secondary | Change From Baseline in Vital Sign: Respiratory Rate-Part 2 | Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Breaths per minute | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
|
|
|
| Secondary | Change From Baseline in Vital Sign: Temperature-Part 2 | Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Degrees Celsius | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 |
|
|
|
| Secondary | Lag Time for Absorption (Tlag) for GSK3640254-Part 1 | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. | PK Parameter Population | Posted | Mean | Standard Deviation | Hours | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
|
|
|
| Secondary | Apparent Terminal Phase Half-life (t1/2) for GSK3640254-Part 1 | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
|
|
|
| Secondary | Apparent Oral Clearance (CL/F) for GSK3640254-Part 1 | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters per hour | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
|
|
|
| Secondary | Apparent Volume of Distribution (Vz/F) for GSK3640254-Part 1 | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
|
|
|
| Secondary | Plasma Concentration of GSK3640254-Part 1 | Blood samples were collected at indicated time points for PK analysis. | PK Concentration Population comprised of all participants who underwent plasma PK sampling and had evaluable PK assay results. | Posted | Median | Full Range | Nanograms per milliliter | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
|
|
|
| Secondary | Tlag for GSK3640254-Part 2 | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Hours | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
|
|
|
| Secondary | T1/2 for GSK3640254-Part 2 | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
|
|
|
| Secondary | CL/F for GSK3640254-Part 2 | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter per hour | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
|
|
|
| Secondary | Vz/F for GSK3640254-Part 2 | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
|
|
|
| Secondary | Plasma Concentration of GSK3640254-Part 2 | Blood samples were collected at indicated time points for PK analysis. | PK Concentration Population. Only those participants with data available at the specified time points were analyzed. | Posted | Median | Full Range | Nanograms per milliliter | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Part 1: GSK3640254 200 mg Tablets | Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2. | 0 | 18 | 0 | 18 | 1 | 18 |
| EG002 | Part 2: GSK3640254 200 mg Tablet (Moderate Fat) | Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG003 | Part 2: GSK3640254 200 mg Tablet (Fasted) | Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. | 0 | 19 | 0 | 19 | 0 | 19 |
| EG004 | Part 2: GSK3640254 200 mg Tablet (High Fat) | Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3. | 0 | 21 | 0 | 21 | 2 | 21 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
| Ratio |
| 2.594 |
| 2-Sided |
| 90 |
| 2.1003 |
| 3.2038 |
Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-inf). Ratio of GSK3640254 200 mg tablet (high fat)/(fasted) |
| Other |
| Ratio |
| 2.785 |
| 2-Sided |
| 90 |
| 2.2943 |
| 3.3807 |
Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-t). Ratio of GSK3640254 200 mg tablet (high fat)/(fasted) |
| Other |
| Ratio |
| 3.080 |
| 2-Sided |
| 90 |
| 2.4359 |
| 3.8935 |
Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter Cmax. Ratio of GSK3640254 200 mg tablet (high fat)/(fasted) |
| Other |
| Title | Measurements |
|---|---|
|
| Basophils; Day 2; n=18, 18 |
|
|
| Basophils; Day 5; n=9, 9 |
|
|
| Eosinophils; Baseline; n=18, 18 |
|
|
| Eosinophils; Day 2; n=18, 18 |
|
|
| Eosinophils; Day 5; n=9, 9 |
|
|
| Lymphocytes; Baseline; n=18, 18 |
|
|
| Lymphocytes; Day 2; n=18, 18 |
|
|
| Lymphocytes; Day 5; n=9, 9 |
|
|
| Monocytes; Baseline; n=18, 18 |
|
|
| Monocytes; Day 2; n=18, 18 |
|
|
| Monocytes; Day 5; n=9, 9 |
|
|
| Neutrophils; Baseline; n=18, 18 |
|
|
| Neutrophils; Day 2; n=18, 18 |
|
|
| Neutrophils; Day 5; n=9, 9 |
|
|
| Platelets; Baseline; n=18, 18 |
|
|
| Platelets; Day 2; n=18, 18 |
|
|
| Platelets; Day 5; n=9, 9 |
|
|
| Day 2; n=18, 18 |
|
|
| Day 5; n=9, 9 |
|
|
| Day 2; n=18, 18 |
|
|
| Day 5; n=9, 9 |
|
|
| Day 2; n=18, 18 |
|
|
| Day 5; n=9, 9 |
|
|
| Day 2; n=18, 18 |
|
|
| Day 5; n=9, 9 |
|
|
| Day 2; n=18, 18 |
|
|
| Day 5; n=9, 9 |
|
|
| Basophils; Day 2; n=20, 19, 21 |
|
|
| Basophils; Day 5; n=7, 5, 7 |
|
|
| Eosinophils; Baseline; n=20, 19, 21 |
|
|
| Eosinophils; Day 2; n=20, 19, 21 |
|
|
| Eosinophils; Day 5; n=7, 5, 7 |
|
|
| Lymphocytes; Baseline; n=20, 19, 21 |
|
|
| Lymphocytes; Day 2; n=20, 19, 21 |
|
|
| Lymphocytes; Day 5; n=7, 5, 7 |
|
|
| Monocytes; Baseline; n=20, 19, 21 |
|
|
| Monocytes; Day 2; n=20, 19, 21 |
|
|
| Monocytes; Day 5; n=7, 5, 7 |
|
|
| Neutrophils; Baseline; n=20, 19, 21 |
|
|
| Neutrophils; Day 2; n=20, 19, 21 |
|
|
| Neutrophils; Day 5; n=7, 5, 7 |
|
|
| Platelets; Baseline; n=20, 19, 21 |
|
|
| Platelets; Day 2; n=20, 19, 21 |
|
|
| Platelets; Day 5; n=7, 5, 7 |
|
|
| Day 2; n=20, 19, 21 |
|
|
| Day 5; n=7, 5, 7 |
|
|
| Day 2; n=20, 19, 21 |
|
|
| Day 5; n=7, 5, 7 |
|
|
| Day 2; n=20, 19, 21 |
|
|
| Day 5; n=7, 5, 7 |
|
|
| Day 2; n=20, 19, 21 |
|
|
| Day 5; n=7, 5, 7 |
|
|
| Day 2; n=20, 19, 21 |
|
|
| Day 5; n=7, 5, 7 |
|
|
| Basophils; Day 5; n=9, 9 |
|
|
| Eosinophils; Day 2; n=18, 18 |
|
|
| Eosinophils; Day 5; n=9, 9 |
|
|
| Lymphocytes; Day 2; n=18, 18 |
|
|
| Lymphocytes; Day 5; n=9, 9 |
|
|
| Monocytes; Day 2; n=18, 18 |
|
|
| Monocytes; Day 5; n=9, 9 |
|
|
| Neutrophils; Day 2; n=18, 18 |
|
|
| Neutrophils; Day 5; n=9, 9 |
|
|
| Platelets; Day 2; n=18, 18 |
|
|
| Platelets; Day 5; n=9, 9 |
|
|
| Day 5; n=9, 9 |
|
|
| Day 5; n=9, 9 |
|
|
| Day 5; n=9, 9 |
|
|
| Day 5; n=9, 9 |
|
|
| Day 5; n=9, 9 |
|
|
| Basophils; Day 5; n=7, 5, 7 |
|
|
| Eosinophils; Day 2; n=20, 19, 21 |
|
|
| Eosinophils; Day 5; n=7, 5, 7 |
|
|
| Lymphocytes; Day 2; n=20, 19, 21 |
|
|
| Lymphocytes; Day 5; n=7, 5, 7 |
|
|
| Monocytes; Day 2; n=20, 19, 21 |
|
|
| Monocytes; Day 5; n=7, 5, 7 |
|
|
| Neutrophils; Day 2; n=20, 19, 21 |
|
|
| Neutrophils; Day 5; n=7, 5, 7 |
|
|
| Platelets; Day 2; n=20, 19, 21 |
|
|
| Platelets; Day 5; n=7, 5, 7 |
|
|
| Day 5; n=7, 5, 7 |
|
|
| Day 5; n=7, 5, 7 |
|
|
| Day 5; n=7, 5, 7 |
|
|
| Day 5; n=7, 5, 7 |
|
|
| Day 5; n=7, 5, 7 |
|
|
| Creatinine; Day 2; n=18, 18 |
|
|
| Creatinine; Day 5; n=9, 9 |
|
|
| Total bilirubin; Baseline; n=18, 18 |
|
|
| Total bilirubin; Day 2; n=18, 18 |
|
|
| Total bilirubin; Day 5; n=9, 9 |
|
|
| Direct bilirubin; Baseline; n=18, 18 |
|
|
| Direct bilirubin; Day 2; n=18, 18 |
|
|
| Direct bilirubin; Day 5; n=9, 9 |
|
|
| Urate; Baseline; n=18, 18 |
|
|
| Urate; Day 2; n=18, 18 |
|
|
| Urate; Day 5; n=9, 9 |
|
|
| Calcium; Day 2; n=18, 18 |
|
|
| Calcium; Day 5; n=9, 9 |
|
|
| Glucose; Baseline; n=18, 18 |
|
|
| Glucose; Day 2; n=18, 18 |
|
|
| Glucose; Day 5; n=9, 9 |
|
|
| Potassium; Baseline; n=18, 18 |
|
|
| Potassium; Day 2; n=18, 18 |
|
|
| Potassium; Day 5; n=9, 9 |
|
|
| Sodium; Baseline; n=18, 18 |
|
|
| Sodium; Day 2; n=18, 18 |
|
|
| Sodium; Day 5; n=9, 9 |
|
|
| Chloride; Baseline; n=18, 18 |
|
|
| Chloride; Day 2; n=18, 18 |
|
|
| Chloride; Day 5; n=9, 9 |
|
|
| Phosphate; Baseline; n=18, 18 |
|
|
| Phosphate; Day 2; n=18, 18 |
|
|
| Phosphate; Day 5; n=9, 9 |
|
|
| BUN; Baseline; n=18, 18 |
|
|
| BUN; Day 2; n=18, 18 |
|
|
| BUN; Day 5; n=9, 9 |
|
|
| Triglycerides; Baseline; n=18, 18 |
|
|
| Triglycerides; Day 2; n=18, 18 |
|
|
| Triglycerides; Day 5; n=9, 9 |
|
|
| Cholesterol; Baseline; n=18, 18 |
|
|
| Cholesterol; Day 2; n=18, 18 |
|
|
| Cholesterol; Day 5; n=9, 9 |
|
|
| Anion gap; Baseline; n=18, 18 |
|
|
| Anion gap; Day 2; n=18, 18 |
|
|
| Anion gap; Day 5; n=9, 9 |
|
|
| Carbon dioxide; Baseline; n=18, 18 |
|
|
| Carbon dioxide; Day 2; n=18, 18 |
|
|
| Carbon dioxide; Day 5; n=9, 9 |
|
|
| ALT; Day 2; n=18, 18 |
|
|
| ALT; Day 5; n=9, 9 |
|
|
| ALP; Baseline; n=18, 18 |
|
|
| ALP; Day 2; n=18, 18 |
|
|
| ALP; Day 5; n=9, 9 |
|
|
| AST; Baseline; n=18, 18 |
|
|
| AST; Day 2; n=18, 18 |
|
|
| AST; Day 5; n=9, 9 |
|
|
| GGT; Baseline; n=18, 18 |
|
|
| GGT; Day 2; n=18, 18 |
|
|
| GGT; Day 5; n=9, 9 |
|
|
| CK; Baseline; n=18, 18 |
|
|
| CK; Day 2; n=18, 18 |
|
|
| CK; Day 5; n=9, 9 |
|
|
| LDH; Baseline; n=18, 18 |
|
|
| LDH; Day 2; n=18, 18 |
|
|
| LDH; Day 5; n=9, 9 |
|
|
| Albumin; Day 2; n=18, 18 |
|
|
| Albumin; Day 5; n=9, 9 |
|
|
| Globulin; Baseline; n=18, 18 |
|
|
| Globulin; Day 2; n=18, 18 |
|
|
| Globulin; Day 5; n=9, 9 |
|
|
| Protein; Baseline; n=18, 18 |
|
|
| Protein; Day 2; n=18, 18 |
|
|
| Protein; Day 5; n=9, 9 |
|
|
| Amylase; Day 2; n=18, 18 |
|
|
| Amylase; Day 5; n=9, 9 |
|
|
| Lipase; Baseline; n=18, 18 |
|
|
| Lipase; Day 2; n=18, 18 |
|
|
| Lipase; Day 5; n=9, 9 |
|
|
| Creatinine; Day 2; n=20, 19, 21 |
|
|
| Creatinine; Day 5; n=7, 5, 7 |
|
|
| Total bilirubin; Baseline; n=20, 19, 21 |
|
|
| Total bilirubin; Day 2; n=20, 19, 21 |
|
|
| Total bilirubin; Day 5; n=7, 5, 7 |
|
|
| Direct bilirubin; Baseline; n=20, 19, 21 |
|
|
| Direct bilirubin; Day 2; n=20, 19, 21 |
|
|
| Direct bilirubin; Day 5; n=7, 5, 7 |
|
|
| Urate; Baseline; n=20, 19, 21 |
|
|
| Urate; Day 2; n=20, 19, 21 |
|
|
| Urate; Day 5; n=7, 5, 7 |
|
|
| Calcium; Day 2; n=20, 19, 21 |
|
|
| Calcium; Day 5; n=7, 5, 7 |
|
|
| Glucose; Baseline; n=20, 19, 21 |
|
|
| Glucose; Day 2; n=20, 19, 21 |
|
|
| Glucose; Day 5; n=7, 5, 7 |
|
|
| Potassium; Baseline; n=20, 19, 21 |
|
|
| Potassium; Day 2; n=20, 19, 21 |
|
|
| Potassium; Day 5; n=7, 5, 7 |
|
|
| Sodium; Baseline; n=20, 19, 21 |
|
|
| Sodium; Day 2; n=20, 19, 21 |
|
|
| Sodium; Day 5; n=7, 5, 7 |
|
|
| Chloride; Baseline; n=20, 19, 21 |
|
|
| Chloride; Day 2; n=20, 19, 21 |
|
|
| Chloride; Day 5; n=7, 5, 7 |
|
|
| Phosphate; Baseline; n=20, 19, 21 |
|
|
| Phosphate; Day 2; n=20, 19, 21 |
|
|
| Phosphate; Day 5; n=7, 5, 7 |
|
|
| BUN; Baseline; n=20, 19, 21 |
|
|
| BUN; Day 2; n=20, 19, 21 |
|
|
| BUN; Day 5; n=7, 5, 7 |
|
|
| Triglycerides; Baseline; n=20, 19, 21 |
|
|
| Triglycerides; Day 2; n=20, 19, 21 |
|
|
| Triglycerides; Day 5; n=7, 5, 7 |
|
|
| Cholesterol; Baseline; n=20, 19, 21 |
|
|
| Cholesterol; Day 2; n=20, 19, 21 |
|
|
| Cholesterol; Day 5; n=7, 5, 7 |
|
|
| Anion gap; Baseline; n=20, 19, 21 |
|
|
| Anion gap; Day 2; n=20, 19, 21 |
|
|
| Anion gap; Day 5; n=7, 5, 7 |
|
|
| Carbon dioxide; Baseline; n=20, 19, 21 |
|
|
| Carbon dioxide; Day 2; n=20, 19, 21 |
|
|
| Carbon dioxide; Day 5; n=7, 5, 7 |
|
|
| ALT; Day 2; n=20, 19, 21 |
|
|
| ALT; Day 5; n=7, 5, 7 |
|
|
| ALP; Baseline; n=20, 19, 21 |
|
|
| ALP; Day 2; n=20, 19, 21 |
|
|
| ALP; Day 5; n=7, 5, 7 |
|
|
| AST; Baseline; n=20, 19, 21 |
|
|
| AST; Day 2; n=20, 19, 21 |
|
|
| AST; Day 5; n=7, 5, 7 |
|
|
| GGT; Baseline; n=20, 19, 21 |
|
|
| GGT; Day 2; n=20, 19, 21 |
|
|
| GGT; Day 5; n=7, 5, 7 |
|
|
| CK; Baseline; n=20, 19, 21 |
|
|
| CK; Day 2; n=20, 19, 21 |
|
|
| CK; Day 5; n=7, 5, 7 |
|
|
| LDH; Baseline; n=20, 19, 21 |
|
|
| LDH; Day 2; n=20, 19, 21 |
|
|
| LDH; Day 5; n=7, 5, 7 |
|
|
| Albumin; Day 2; n=20, 19, 21 |
|
|
| Albumin; Day 5; n=7, 5, 7 |
|
|
| Globulin; Baseline; n=20, 19, 21 |
|
|
| Globulin; Day 2; n=20, 19, 21 |
|
|
| Globulin; Day 5; n=7, 5, 7 |
|
|
| Protein; Baseline; n=20, 19, 21 |
|
|
| Protein; Day 2; n=20, 19, 21 |
|
|
| Protein; Day 5; n=7, 5, 7 |
|
|
| Amylase; Day 2; n=20, 19, 21 |
|
|
| Amylase; Day 5; n=7, 5, 7 |
|
|
| Lipase; Baseline; n=20, 19, 21 |
|
|
| Lipase; Day 2; n=20, 19, 21 |
|
|
| Lipase; Day 5; n=7, 5, 7 |
|
|
| Creatinine; Day 5; n=9, 9 |
|
|
| Total bilirubin; Day 2; n=18, 18 |
|
|
| Total bilirubin; Day 5; n=9, 9 |
|
|
| Direct bilirubin; Day 2; n=18, 18 |
|
|
| Direct bilirubin; Day 5; n=9, 9 |
|
|
| Urate; Day 2; n=18, 18 |
|
|
| Urate; Day 5; n=9, 9 |
|
|
| Calcium; Day 5; n=9, 9 |
|
|
| Glucose; Day 2; n=18, 18 |
|
|
| Glucose; Day 5; n=9, 9 |
|
|
| Potassium; Day 2; n=18, 18 |
|
|
| Potassium; Day 5; n=9, 9 |
|
|
| Sodium; Day 2; n=18, 18 |
|
|
| Sodium; Day 5; n=9, 9 |
|
|
| Chloride; Day 2; n=18, 18 |
|
|
| Chloride; Day 5; n=9, 9 |
|
|
| Phosphate; Day 2; n=18, 18 |
|
|
| Phosphate; Day 5; n=9, 9 |
|
|
| BUN; Day 2; n=18, 18 |
|
|
| BUN; Day 5; n=9, 9 |
|
|
| Triglycerides; Day 2; n=18, 18 |
|
|
| Triglycerides; Day 5; n=9, 9 |
|
|
| Cholesterol; Day 2; n=18, 18 |
|
|
| Cholesterol; Day 5; n=9, 9 |
|
|
| Anion gap; Day 2; n=18, 18 |
|
|
| Anion gap; Day 5; n=9, 9 |
|
|
| Carbon dioxide; Day 2; n=18, 18 |
|
|
| Carbon dioxide; Day 5; n=9, 9 |
|
|
| ALT; Day 5; n=9, 9 |
|
|
| ALP; Day 2; n=18, 18 |
|
|
| ALP; Day 5; n=9, 9 |
|
|
| AST; Day 2; n=18, 18 |
|
|
| AST; Day 5; n=9, 9 |
|
|
| GGT; Day 2; n=18, 18 |
|
|
| GGT; Day 5; n=9, 9 |
|
|
| CK; Day 2; n=18, 18 |
|
|
| CK; Day 5; n=9, 9 |
|
|
| LDH; Day 2; n=18, 18 |
|
|
| LDH; Day 5; n=9, 9 |
|
|
| Albumin; Day 5; n=9, 9 |
|
|
| Globulin; Day 2; n=18, 18 |
|
|
| Globulin; Day 5; n=9, 9 |
|
|
| Protein; Day 2; n=18, 18 |
|
|
| Protein; Day 5; n=9, 9 |
|
|
| Amylase; Day 5; n=9, 9 |
|
|
| Lipase; Day 2; n=18, 18 |
|
|
| Lipase; Day 5; n=9, 9 |
|
|
| Creatinine; Day 5; n=7, 5, 7 |
|
|
| Total bilirubin; Day 2; n=20, 19, 21 |
|
|
| Total bilirubin; Day 5; n=7, 5, 7 |
|
|
| Direct bilirubin; Day 2; n=20, 19, 21 |
|
|
| Direct bilirubin; Day 5; n=7, 5, 7 |
|
|
| Urate; Day 2; n=20, 19, 21 |
|
|
| Urate; Day 5; n=7, 5, 7 |
|
|
| Calcium; Day 5; n=7, 5, 7 |
|
|
| Glucose; Day 2; n=20, 19, 21 |
|
|
| Glucose; Day 5; n=7, 5, 7 |
|
|
| Potassium; Day 2; n=20, 19, 21 |
|
|
| Potassium; Day 5; n=7, 5, 7 |
|
|
| Sodium; Day 2; n=20, 19, 21 |
|
|
| Sodium; Day 5; n=7, 5, 7 |
|
|
| Chloride; Day 2; n=20, 19, 21 |
|
|
| Chloride; Day 5; n=7, 5, 7 |
|
|
| Phosphate; Day 2; n=20, 19, 21 |
|
|
| Phosphate; Day 5; n=7, 5, 7 |
|
|
| BUN; Day 2; n=20, 19, 21 |
|
|
| BUN; Day 5; n=7, 5, 7 |
|
|
| Triglycerides; Day 2; n=20, 19, 21 |
|
|
| Triglycerides; Day 5; n=7, 5, 7 |
|
|
| Cholesterol; Day 2; n=20, 19, 21 |
|
|
| Cholesterol; Day 5; n=7, 5, 7 |
|
|
| Anion gap; Day 2; n=20, 19, 21 |
|
|
| Anion gap; Day 5; n=7, 5, 7 |
|
|
| Carbon dioxide; Day 2; n=20, 19, 21 |
|
|
| Carbon dioxide; Day 5; n=7, 5, 7 |
|
|
| ALT; Day 5; n=7, 5, 7 |
|
|
| ALP; Day 2; n=20, 19, 21 |
|
|
| ALP; Day 5; n=7, 5, 7 |
|
|
| AST; Day 2; n=20, 19, 21 |
|
|
| AST; Day 5; n=7, 5, 7 |
|
|
| GGT; Day 2; n=20, 19, 21 |
|
|
| GGT; Day 5; n=7, 5, 7 |
|
|
| CK; Day 2; n=20, 19, 21 |
|
|
| CK; Day 5; n=7, 5, 7 |
|
|
| LDH; Day 2; n=20, 19, 21 |
|
|
| LDH; Day 5; n=7, 5, 7 |
|
|
| Albumin; Day 5; n=7, 5, 7 |
|
|
| Globulin; Day 2; n=20, 19, 21 |
|
|
| Globulin; Day 5; n=7, 5, 7 |
|
|
| Protein; Day 2; n=20, 19, 21 |
|
|
| Protein; Day 5; n=7, 5, 7 |
|
|
| Amylase; Day 5; n=7, 5, 7 |
|
|
| Lipase; Day 2; n=20, 19, 21 |
|
|
| Lipase; Day 5; n=7, 5, 7 |
|
|
| Day 2; n=18, 18 |
|
|
| Day 5; n=9, 9 |
|
|
| Day 2; n=18, 18 |
|
|
| Day 5; n=9, 9 |
|
|
| Day 2; n=18, 18 |
|
|
| Day 5; n=9, 9 |
|
|
| Day 2; n=20, 19, 21 |
|
|
| Day 5; n=7, 5, 7 |
|
|
| Day 2; n=20, 19, 21 |
|
|
| Day 5; n=7, 5, 7 |
|
|
| Day 2; n=20, 19, 21 |
|
|
| Day 5; n=7, 5, 7 |
|
|
| Day 5; n=9, 9 |
|
|
| Day 5; n=9, 9 |
|
|
| Day 5; n=9, 9 |
|
|
| Day 5; n=7, 5, 7 |
|
|
| Day 5; n=7, 5, 7 |
|
|
| Day 5; n=7, 5, 7 |
|
|
| Leukocyte esterase, Day 5, Trace |
|
| Leukocyte esterase, Day 5, 1+ |
|
| Occult blood, Day 2, Trace |
|
| Occult blood, Day 2, 1+ |
|
| Title | Measurements |
|---|---|
|
| Leukocyte esterase; Day 2; 1+ |
|
| Occult blood; Day 2; Trace |
|
| Occult blood; Day 2; 2+ |
|
| Occult blood; Day 2; 3+ |
|
| PR interval, Day 1 (2 hours); n=18, 18 |
|
|
| PR interval, Day 1 (4 hours); n=18, 18 |
|
|
| PR interval, Day 5; n=9, 9 |
|
|
| QRS duration, Baseline; n=18, 18 |
|
|
| QRS duration, Day 1 (2 hours); n=18, 18 |
|
|
| QRS duration, Day 1 (4 hours); n=18, 18 |
|
|
| QRS duration, Day 5; n=9, 9 |
|
|
| QT interval, Baseline; n=18, 18 |
|
|
| QT interval, Day 1 (2 hours); n=18, 18 |
|
|
| QT interval, Day 1 (4 hours); n=18, 18 |
|
|
| QT interval, Day 5; n=9, 9 |
|
|
| QTcF interval, Baseline; n=18, 18 |
|
|
| QTcF interval, Day 1 (2 hours); n=18, 18 |
|
|
| QTcF interval, Day 1 (4 hours); n=18, 18 |
|
|
| QTcF interval, Day 5; n=9, 9 |
|
|
| PR interval, Day 1 (2 hours); n=20, 19, 21 |
|
|
| PR interval, Day 1 (4 hours); n=20, 19, 21 |
|
|
| PR interval, Day 5; n=7, 5, 7 |
|
|
| QRS duration, Baseline; n=20, 19, 21 |
|
|
| QRS duration, Day 1 (2 hours); n=20, 19, 21 |
|
|
| QRS duration, Day 1 (4 hours); n=20, 19, 21 |
|
|
| QRS duration, Day 5; n=7, 5, 7 |
|
|
| QT interval, Baseline; n=20, 19, 21 |
|
|
| QT interval, Day 1 (2 hours); n=20, 19, 21 |
|
|
| QT interval, Day 1 (4 hours); n=20, 19, 21 |
|
|
| QT interval, Day 5; n=7, 5, 7 |
|
|
| QTcF interval, Baseline; n=20, 19, 21 |
|
|
| QTcF interval, Day 1 (2 hours); n=20, 19, 21 |
|
|
| QTcF interval, Day 1 (4 hours); n=20, 19, 21 |
|
|
| QTcF interval, Day 5; n=7, 5, 7 |
|
|
| PR interval, Day 1 (4 hours); n=18, 18 |
|
|
| PR interval, Day 5; n=9, 9 |
|
|
| QRS duration, Day 1 (2 hours); n=18, 18 |
|
|
| QRS duration, Day 1 (4 hours); n=18, 18 |
|
|
| QRS duration, Day 5; n=9, 9 |
|
|
| QT interval, Day 1 (2 hours); n=18, 18 |
|
|
| QT interval, Day 1 (4 hours); n=18, 18 |
|
|
| QT interval, Day 5; n=9, 9 |
|
|
| QTcF interval, Day 1 (2 hours); n=18, 18 |
|
|
| QTcF interval, Day 1 (4 hours); n=18, 18 |
|
|
| QTcF interval, Day 5; n=9, 9 |
|
|
| PR interval, Day 1 (4 hours); n=20, 19, 21 |
|
|
| PR interval, Day 5; n=7, 5, 7 |
|
|
| QRS duration, Day 1 (2 hours); n=20, 19, 21 |
|
|
| QRS duration, Day 1 (4 hours); n=20, 19, 21 |
|
|
| QRS duration, Day 5; n=7, 5, 7 |
|
|
| QT interval, Day 1 (2 hours); n=20, 19, 21 |
|
|
| QT interval, Day 1 (4 hours); n=20, 19, 21 |
|
|
| QT interval, Day 5; n=7, 5, 7 |
|
|
| QTcF interval, Day 1 (2 hours); n=20, 19, 21 |
|
|
| QTcF interval, Day 1 (4 hours); n=20, 19, 21 |
|
|
| QTcF interval, Day 5; n=7, 5, 7 |
|
|
| SBP; Day 2 |
|
|
| SBP; Day 3 |
|
|
| SBP; Day 4 |
|
|
| SBP; Day 5 |
|
|
| DBP; Baseline |
|
|
| DBP; Day 2 |
|
|
| DBP; Day 3 |
|
|
| DBP; Day 4 |
|
|
| DBP; Day 5 |
|
|
| Day 3 |
|
| Day 4 |
|
| Day 5 |
|
| Day 2; n=17, 17 |
|
|
| Day 3; n=17, 18 |
|
|
| Day 4; n=18, 18 |
|
|
| Day 5; n=18, 18 |
|
|
| Day 3 |
|
| Day 4 |
|
| Day 5 |
|
| SBP, Day 2 |
|
|
| SBP, Day 3 |
|
|
| SBP, Day 4 |
|
|
| SBP, Day 5 |
|
|
| DBP, Baseline |
|
|
| DBP, Day 2 |
|
|
| DBP, Day 3 |
|
|
| DBP, Day 4 |
|
|
| DBP, Day 5 |
|
|
|
| Day 3 |
|
| Day 4 |
|
| Day 5 |
|
|
| Day 3 |
|
| Day 4 |
|
| Day 5 |
|
|
| Day 3 |
|
| Day 4 |
|
| Day 5 |
|
| SBP; Day 3 |
|
|
| SBP; Day 4 |
|
|
| SBP; Day 5 |
|
|
| DBP; Day 2 |
|
|
| DBP; Day 3 |
|
|
| DBP; Day 4 |
|
|
| DBP; Day 5 |
|
|
| Day 4 |
|
| Day 5 |
|
| Day 3; n=17, 18 |
|
|
| Day 4; n=18, 18 |
|
|
| Day 5; n=18, 18 |
|
|
| Day 4 |
|
| Day 5 |
|
| SBP, Day 3 |
|
|
| SBP, Day 4 |
|
|
| SBP, Day 5 |
|
|
| DBP, Day 2 |
|
|
| DBP, Day 3 |
|
|
| DBP, Day 4 |
|
|
| DBP, Day 5 |
|
|
|
| Day 4 |
|
| Day 5 |
|
|
| Day 4 |
|
| Day 5 |
|
|
| Day 4 |
|
| Day 5 |
|
| 1.5 hours |
|
| 2 hours |
|
| 2.5 hours |
|
| 3 hours |
|
| 3.5 hours |
|
| 4 hours |
|
| 4.5 hours |
|
| 5 hours |
|
| 6 hours |
|
| 8 hours |
|
| 12 hours |
|
| 24 hours |
|
| 48 hours |
|
| 72 hours |
|
| 96 hours |
|
| 1 hour |
|
| 1.5 hours |
|
| 2 hours |
|
| 2.5 hours |
|
| 3 hours |
|
| 3.5 hours |
|
| 4 hours |
|
| 4.5 hours |
|
| 5 hours |
|
| 6 hours |
|
| 8 hours |
|
| 12 hours |
|
| 24 hours |
|
| 48 hours |
|
| 72 hours |
|
| 96 hours |
|