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This is an open-label, single-center, single dose, non-randomized, sequential, fixed-sequence study, which will evaluate pharmacokinetics (PK) of dolutegravir (DTG) in healthy adult subjects. The study will contain 6 periods with five prototype liquid formulations for evaluation in fasted state. In period 1, 2 and 3 single reference dose of 2 dispersible tablets of 5 milligram DTG will be administered and at least 2 liquid prototype DTG formulations (containing a target total dose of 10mg DTG). There will be a wash-out period of 7 days between each period. In period 4 through 6, there would be options to evaluate additional prototype liquid formulations. The total duration of study will be up to 17 weeks. DTG has been found to be safe and effective in adults infected with human immunodeficiency virus (HIV). DTG dispersible tablets have been developed primarily for use in children from 4 weeks to 6 years of age, and a DTG liquid formulation are is being developed to study the appropriate dose needed for the HIV-exposed and infected neonatal population in the first four weeks of life. Approximately 18 subjects will be enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subject receiving Dolutegravir 10 mg | Experimental | Subject will receive a prototype equivalent to DTG 10 mg liquid formulation in period 1, a prototype equivalent to DTG 10 mg liquid formulation in period 2, a DTG 10 mg dispersible tablet in Period 3, each period will be separated by washout period of >= 7 days, if required a prototype equivalent to DTG 10 mg liquid formulation in period 4, a prototype equivalent to DTG 10 mg liquid formulation in period 5, and a prototype equivalent to DTG 10 mg liquid formulation in period 6 will be evaluated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dolutegravir dispersible tablet | Drug | DTG will be available as an oral tablet with dosing strength of 5 mg 2 tablet will be dispersed in water will be administered orally for prescribed regimen. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Time Point (AUC[0-t]) for DTG | Blood samples were collected at indicated time points and pharmacokinetic (PK) analysis was performed. PK parameters were determined by non-compartmental methods. | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose |
| AUC From Time Zero to Infinity (AUC[0-inf]) for DTG | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods. | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose |
| Maximum Observed Concentration (Cmax) for DTG | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods. | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Absorption Lag Time (Tlag) Following Administration of DTG | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods. | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose |
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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 | Nottingham | NG11 6JS | United Kingdom |
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 22 participants were enrolled in the study. The washout time between dosing in consecutive study periods was a minimum of 7 days.
This was a Phase 1, open-label, non-randomized, single dose study in healthy adult participants conducted at a single center in the United Kingdom (UK) to assess the prototype liquid fomulations of dolutegravir (DTG) versus DTG dispersible tablets (reference).
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| ID | Title | Description |
|---|---|---|
| FG000 | Prototype A/DTG Reference/Prototype B | Participants were administered a single oral dose of 5 milligrams (mg) per milliliter (mL) DTG sodium oral suspension (Prototype A), for a total of 10 mg in Period 1 followed by a single oral dose of two 5 mg DTG dispersible tablets dispersed in water (DTG reference) in Period 2. Participants further received a single oral dose of 2 mg/mL DTG sodium oral liquid (Prototype B) in Period 3, also receiving a total dose of 10 mg. There was a minimum washout of 7 days between doses. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (4 Days) |
| |||||||||||||
| Period 2 (4 Days) |
| |||||||||||||
| Period 3 (4 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prototype A/DTG Reference/Prototype B | Participants were administered a single oral dose of 5 milligrams (mg) per milliliter (mL) DTG sodium oral suspension (Prototype A), for a total of 10 mg in Period 1 followed by a single oral dose of two 5 mg DTG dispersible tablets dispersed in water (DTG reference) in Period 2. Participants further received a single oral dose of 2 mg/mL DTG sodium oral liquid (Prototype B) in Period 3, also receiving a total dose of 10 mg. There was a minimum washout of 7 days between doses. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 to the Last Quantifiable Time Point (AUC[0-t]) for DTG | Blood samples were collected at indicated time points and pharmacokinetic (PK) analysis was performed. PK parameters were determined by non-compartmental methods. | PK Population comprised of participants in the 'All Participants' (who were randomized and received at least one dose of study medication)' population for whom a PK sample was obtained and had evaluable PK assay results. Only those participants with data available at the specified data points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*micrograms per milliliter | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose |
|
Non-serious and serious adverse events were collected up to Week 11
Non-serious AEs and SAEs were collected in the Safety Population
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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 | Prototype A | Participants received a single oral dose of Prototype A (5 mg/mL DTG oral suspension) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 22.0 | 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 27, 2019 | May 4, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 17, 2019 | May 4, 2020 | 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 |
|---|---|
| C562325 | dolutegravir |
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The study is non-randomized 6 period, 6 way fixed sequential design.
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| Dolutegravir oral suspension | Drug | DTG will be available as an oral suspension with dosing strength of 5 mg per milliliter (ml) or 2 mg per ml with miglyol 812N or ethyl cellulose in miglyol 812N as vehicle for suspension administered orally for prescribed regimen. |
|
| Dolutegravir oral solution | Drug | DTG will be available as an oral solution with dosing strength of 2 mg per ml will be administered orally for prescribed regimen. |
|
| Time of Maximum Observed Concentration (Tmax) Following Administration of DTG |
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods. |
| Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose |
| Time of Last Quantifiable Concentration (Tlast) Following Administration of DTG | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods. | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose |
| Elimination Half-life (t½) Following Administration of DTG | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods. | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose |
| Apparent Elimination Rate Constant (Lambda z) Following Administration of DTG | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods. | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose |
| Percentage of AUC(0-inf) Extrapolated (%AUCex) Following Administration of DTG | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods. | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose |
| AUC From Time Zero to 24 Hours (AUC[0-24]) Following Administration of DTG | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods. | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, and 24 hours post-dose |
| AUC From Time Zero to 72 Hours (AUC[0-72]) Following Administration of DTG | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods. | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
| Apparent Oral Clearance (CL/F) Following Administration of DTG | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods. | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
| Last Quantifiable Concentration (Ct) Following Administration of DTG | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods. | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
| Apparent Oral Volume of Distribution (Vz/F) Following Administration of DTG | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods. | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
| Concentration at 24hours Post-dose (C24) Following Administration of DTG | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods. | 24 hours |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP and DBP was measured in a supine position after at least 5 minutes of rest for the participant in a quiet setting without any distractions using a completely automated device. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specific time point value. | Baseline (Day -1) and Day 4 |
| Change From Baseline in Pulse Rate | Pulse rate was measured in a supine position after at least 5 minutes of rest for the participant in a quiet setting without any distractions using a completely automated device. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specific time point value. | Baseline (Day -1) and Day 4 |
| Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. A SAE is defined as any untoward medical occurrence that, at any dose results in death,is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgement. | Up to Week 11 |
| Number of Participants With Clinically Significant Hematology Parameters | Blood samples were collected to analyze the following hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, hemoglobin, hematocrit, mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), percentage reticulocytes and red blood cell count. Data for clinically significant abnormal hematology parameters have been presented. Clinically significant abnormal laboratory findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | Baseline (Day -1) |
| Number of Participants With Clinically Significant Chemistry Parameters | Blood samples were collected to analyze the following clinical chemistry parameters: Potassium, calcium, sodium, creatinine, glucose, alkaline phosphatase, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Blood urea nitrogen (BUN), total and direct bilirubin, total protein and creatine kinase. Data for clinically significant abnormal clinical chemistry parameters have been presented. Clinically significant abnormal laboratory findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | Baseline (Day -1) |
| Number of Participants With Clinically Significant Urine Parameters | Urine samples were collected to analyze the following urinalysis parameters: specific gravity, potential of hydrogen (pH). Clinically significant abnormal laboratory findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | Baseline (Day -1) |
|
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Prototype B | Participants received a single oral dose of Prototype B (2 mg/mL DTG [as DTG Sodium in glycerol vehicle] oral liquid) |
| OG002 | DTG Reference | Participants received a single oral dose of DTG reference tablets (2x5 mg DTG dispersible tablets dispersed in water) |
|
|
|
| Secondary | Absorption Lag Time (Tlag) Following Administration of DTG | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods. | PK Population. Only those participants with data available at the specified data points were analyzed. | Posted | Median | Full Range | Hours | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose |
|
|
|
| Secondary | Time of Maximum Observed Concentration (Tmax) Following Administration of DTG | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods. | PK Population. Only those participants with data available at the specified data points were analyzed. | Posted | Median | Full Range | Hours | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose |
|
|
|
| Secondary | Time of Last Quantifiable Concentration (Tlast) Following Administration of DTG | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods. | PK Population. Only those participants with data available at the specified data points were analyzed. | Posted | Median | Full Range | Hours | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose |
|
|
|
| Secondary | Elimination Half-life (t½) Following Administration of DTG | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods. | PK Population. Only those participants with data available at the specified data points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose |
|
|
|
| Secondary | Apparent Elimination Rate Constant (Lambda z) Following Administration of DTG | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods. | PK Population. Only those participants with data available at the specified data points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Per hour | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose |
|
|
|
| Secondary | Percentage of AUC(0-inf) Extrapolated (%AUCex) Following Administration of DTG | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods. | PK Population. Only those participants with data available at the specified data points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage of AUCex | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose |
|
|
|
| Secondary | AUC From Time Zero to 24 Hours (AUC[0-24]) Following Administration of DTG | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods. | PK Population. Only those participants with data available at the specified data points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*micrograms per milliliter | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, and 24 hours post-dose |
|
|
|
| Secondary | AUC From Time Zero to 72 Hours (AUC[0-72]) Following Administration of DTG | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods. | PK Population. Only those participants with data available at the specified data points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*micrograms per milliliter | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
|
|
|
| Secondary | Apparent Oral Clearance (CL/F) Following Administration of DTG | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods. | PK Population. Only those participants with data available at the specified data points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters per hour | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
|
|
|
| Secondary | Last Quantifiable Concentration (Ct) Following Administration of DTG | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods. | PK Population. Only those participants with data available at the specified data points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
|
|
|
| Secondary | Apparent Oral Volume of Distribution (Vz/F) Following Administration of DTG | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods. | PK Population. Only those participants with data available at the specified data points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
|
|
|
| Secondary | Concentration at 24hours Post-dose (C24) Following Administration of DTG | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods. | PK Population. Only those participants with data available at the specified data points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | 24 hours |
|
|
|
| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP and DBP was measured in a supine position after at least 5 minutes of rest for the participant in a quiet setting without any distractions using a completely automated device. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specific time point value. | Safety Population. All participants who were randomized and received at least one dose of study medication were part of Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline (Day -1) and Day 4 |
|
|
|
| Secondary | Change From Baseline in Pulse Rate | Pulse rate was measured in a supine position after at least 5 minutes of rest for the participant in a quiet setting without any distractions using a completely automated device. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specific time point value. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Beats per minute | Baseline (Day -1) and Day 4 |
|
|
|
| Secondary | Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. A SAE is defined as any untoward medical occurrence that, at any dose results in death,is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgement. | Safety Population. | Posted | Count of Participants | Participants | Up to Week 11 |
|
|
|
| Secondary | Number of Participants With Clinically Significant Hematology Parameters | Blood samples were collected to analyze the following hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, hemoglobin, hematocrit, mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), percentage reticulocytes and red blood cell count. Data for clinically significant abnormal hematology parameters have been presented. Clinically significant abnormal laboratory findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | Safety Population. | Posted | Count of Participants | Participants | Baseline (Day -1) |
|
|
|
| Secondary | Number of Participants With Clinically Significant Chemistry Parameters | Blood samples were collected to analyze the following clinical chemistry parameters: Potassium, calcium, sodium, creatinine, glucose, alkaline phosphatase, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Blood urea nitrogen (BUN), total and direct bilirubin, total protein and creatine kinase. Data for clinically significant abnormal clinical chemistry parameters have been presented. Clinically significant abnormal laboratory findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | Safety Population. | Posted | Count of Participants | Participants | Baseline (Day -1) |
|
|
|
| Secondary | Number of Participants With Clinically Significant Urine Parameters | Urine samples were collected to analyze the following urinalysis parameters: specific gravity, potential of hydrogen (pH). Clinically significant abnormal laboratory findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | Safety Population. | Posted | Count of Participants | Participants | Baseline (Day -1) |
|
|
|
| Primary | AUC From Time Zero to Infinity (AUC[0-inf]) for DTG | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods. | PK Population. Only those participants with data available at the specified data points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*micrograms per milliliter | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose |
|
|
|
|
| Primary | Maximum Observed Concentration (Cmax) for DTG | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods. | PK Population. Only those participants with data available at the specified data points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3,3.5, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose |
|
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 3 |
| 18 |
| EG001 | Prototype B | Participants received a single oral dose of Prototype B (2 mg/mL DTG [as DTG Sodium in glycerol vehicle] oral liquid) | 0 | 19 | 0 | 19 | 3 | 19 |
| EG002 | DTG Reference | Participants received a single oral dose of DTG reference tablets (2x5 mg DTG dispersible tablets dispersed in water) | 0 | 22 | 0 | 22 | 4 | 22 |
| Tension headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 22.0 | 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 |
|
| Title | Measurements |
|---|---|
|
| Ratio |
| 1.13 |
| 90 |
| 1.06 |
| 1.20 |
| Equivalence |
Bioequivalence is established when the 90% confidence interval of the ratio for AUC (0 to inf) between treatment formulations (Prototype B versus DTG Reference Treatment) are within the range of 0.80 to 1.25 |
| Ratio |
| 1.22 |
| 2-Sided |
| 90 |
| 1.13 |
| 1.33 |
| Equivalence |
Bioequivalence is established when the 90% confidence interval of the ratio for Cmax between treatment formulations (Prototype B versus DTG Reference Treatment) are within the range of 0.80 to 1.25 |