HIV Infections
Conditions
Keywords
Dispersible tablets, Bioavailability, Dolutegravir, Healthy, Conventional tablets
Brief summary
The aim of this cross-over study is to compare the relative bioavailability and pharmacokinetic parameters of both 10 mg conventional tablets and 5 mg dispersible tablets of dolutegravir (DTG) with that of 25 mg or 50 mg conventional DTG tablets. The study will be carried out in 2 parts. Part 1 of the study will be open-label, 2 period designs with a wash out period of at least 7 days between the dosing periods. Subjects will be randomized to receive either single dose of five 10 mg DTG tablets or one 50 mg DTG tablet in a crossover manner in the fasting state. Part 2 of the study will be a 3 period crossover design with a wash out period of at least 7 days between the dosing periods. Subjects will be randomized to receive either single dose of five 5 mg DTG tablets (administered as dispersed with water or directly to mouth) or one 25 mg DTG tablet in a crossover manner in the fasting state. Subjects will have a follow-up visit 7-10 days post last dose of study treatment. Approximately 14 healthy subjects will participate in Part 1 and approximately 24 healthy subjects will participate in Part 2 of the study. The total duration of Part 1 will be approximately 7 to 8 weeks and that of part 2 will be approximately 8 to 9 weeks. TIVICAY® is a trademark of the GlaxoSmithKline group of companies.
Interventions
DRUGConventional dolutegravir 10 mg tablet
Single dose of five 10 mg DTG tablets will be administered directly to mouth with 240 mL of water in the morning to randomized subjects in fasting state present in Part 1. DTG will be a white, round shaped, biconvex tablet.
DRUGConventional dolutegravir 50 mg tablet
Single dose of one 50 mg tablet will be administered directly to mouth with 240 mL of water in the morning to randomized subjects in fasting state present in Part 1. DTG will be a white, round shaped, biconvex tablet.
DRUGDispersible dolutegravir 5 mg tablet
Single dose of five 5 mg DTG tablets will be administered as dispersed in water or direct to mouth with 240 mL of water in the morning to randomized subjects in fasting state present in Part 2. DTG will be a white, round shaped, biconvex tablet.
DRUGConventional dolutegravir 25 mg tablet
Single dose of one 25 mg DTG tablet will be administered directly to mouth with 240 mL of water in the morning to randomized subjects in fasting state present in Part 2. DTG will be a white, round shaped, biconvex tablet.
Sponsors
GlaxoSmithKline
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Between 18 and 65 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac evaluation (history and electrocardiogram \[ECG\]). A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or
Exclusion criteria
, outside the reference range for the population being studied may be included only if the investigator in consultation with the Medical Monitor agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. * Body weight \>= 50 kilogram (kg) for males and \>= 45 kg for females and body mass index (BMI) within the range 18.5 - 31.0 kg per meter square (kg/m\^2) (inclusive). * Male or female. Non-reproductive potential defined as: Pre-menopausal females with one of the following: Documented tubal ligation; Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; Hysterectomy; Documented Bilateral Oophorectomy. Postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause\]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication and until 2 weeks after dosing with study medication and completion of the follow-up visit. * Capable of giving signed informed consent which includes compliance with the requirements and restrictions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration-time Curve From Time of Dose Extrapolated to Infinite Time (AUC[0-infinity]) of DTG for Part 1 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the pharmacokinetic (PK) profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. The PK Population was defined as participants in the All Subjects Population for whom a PK sample was obtained and that had evaluable PK assay results. |
| Area Under the Plasma Concentration-time Curve From Time of Dose to Last Measurable Concentration AUC [0-t] of DTG for Part 1 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.. |
| Maximum Observed Concentration (Cmax) of DTG for Part 1 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| AUC (0-infinity) of DTG for Part 2 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Terminal Phase Half-life (t1/2) of DTG for Part 1 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| Terminal-phase Rate Constant (Lambda z) of DTG for Part 1 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| Percentage of AUC (0-infinity) Obtained by Extrapolation (%AUCex) of DTG for Part 1 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| Area Under the Concentration-time Curve Over Time Zero (Pre-dose) to 24 Hours After Dose Administration (AUC[0-24]) of DTG for Part 1 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| Apparent Oral Clearance (CL/F) of DTG for Part 1 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.. |
| Apparent Volume of Distribution During the Terminal Phase (Vz/F) of DTG for Part 1 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| Last Observed Quantifiable Concentration (Ct) of DTG for Part 1 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| Observed Concentration at 24 Hours After Dose Administration (C24) of DTG for Part 1 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| Plasma DTG Tlag for Part 2 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| Tmax of DTG for Part 2 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2 | Blood sample were collected at the indicated time points after administration of study treatment to investigate the pharmacokinetic profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| t1/2 of DTG for Part 2 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| Lambda Z of DTG for Part 2 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times |
| %AUCex of DTG for Part 2 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| AUC (0-24) of DTG for Part 2 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| DTG CL/F for Part 2 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| Vz/F of DTG for Part 2 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| Ct of DTG for Part 2 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times |
| C24 of DTG for Part 2 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) for Part 1 | Up to 25 days in Part 1 | AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Data has been presented for AEs and SAEs up-to follow-up (25 days) in Part 1. All Subjects Population was defined as all participants who received at least 1 dose of study medication. |
| Number of Participants With Adverse Events AEs and Serious Adverse Events SAEs for Part 2 | Up to 36 days in Part 2 | AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Data has been presented for AEs and SAEs up-to follow-up (36 days) in Part 2. |
| Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1 | Baseline and up to 25 days in Part 1 | Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum glucose, serum calcium, serum potassium, serum sodium, serum urea results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). |
| Change From Baseline in Clinical Chemistry Parameters Serum Alanine Amino Transferase (ALT), Serum Alkaline Phosphatase, Serum Aspartate Amino Transferase (AST), Serum Creatine Kinase for Part 1 | Baseline and up to 25 days in Part 1 | Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum ALT, serum alkaline phosphatase, serum AST, serum creatine kinase results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). |
| Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1 | Baseline and up to 25 days in Part 1 | Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum albumin and serum protein results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). |
| Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1 | Baseline and up to 25 days in Part 1 | Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum bilirubin, serum creatinine and serum direct bilirubin results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). |
| Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Baseline and up to 36 days in Part 2 | Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum glucose, serum calcium, serum potassium, serum sodium, serum urea results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). |
| Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2 | Baseline and up to 36 days in Part 2 | Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum ALT, serum alkaline phosphatase, serum AST, serum creatine kinase results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). |
| Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2 | Baseline and up to 36 days in Part 2 | Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum albumin and serum protein results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). |
| Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatine and Serum Direct Bilirubin for Part 2 | Baseline and up to 36 days in Part 2 | Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum bilirubin, serum creatine and serum direct bilirubin results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). |
| Change From Baseline in Hematology Parameter Blood Erythrocyte Mean Corpuscular Hemoglobin (MCH) for Part 1 | Baseline and up to 25 days in Part 1 | Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocyte MCH results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). |
| Change From Baseline in Hematology Parameter Blood Erythrocyte Mean Corpuscular Volume (MCV) for Part 1 | Baseline and up to 25 days in Part 1 | Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocyte MCV results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles). |
| Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Baseline and up to 25 days in Part 1 | Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils, blood platelets results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles) |
| Change From Baseline in Hematology Parameter Blood Hemoglobin for Part 1 | Baseline and up to 25 days in Part 1 | Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood hemoglobin results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles) |
| Change From Baseline in Hematology Parameter Blood Hematocrit for Part 1 | Baseline and up to 25 days in Part 1 | Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood hematocrit results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles). |
| Change From Baseline in Hematology Parameter Blood Erythrocytes for Part 1 | Baseline and up to 25 days in Part 1 | Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocyte results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles). |
| Change From Baseline in Hematology Parameter Blood Erythrocyte MCH for Part 2 | Baseline and up to 36 days in Part 2 | Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocyte MCH results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles). |
| Change From Baseline in Hematology Parameter Blood Erythrocyte MCV for Part 2 | Baseline and up to 36 days in Part 2 | Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocyte MCV results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles). |
| Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Baseline and up to 36 days in Part 2 | Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils, blood platelets results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles) |
| Change From Baseline in Hematology Parameter Blood Hemoglobin for Part 2 | Baseline and up to 36 days in Part 2 | Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood hemoglobin results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles) |
| Change From Baseline in Hematology Parameter Blood Hematocrit for Part 2 | Baseline and up to 36 days in Part 2 | Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood hematocrit results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles) |
| Change From Baseline in Hematology Parameter Blood Erythrocytes for Part 2 | Baseline and up to 36 days in Part 2 | Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocytes results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles). |
| Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Up to 25 days in Part 1 | Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood and urine protein. In this dipstick test, the level of ketones, glucose, occult blood and protein in urine samples was recorded as negative trace, 1+, 2+, and 3+ (the plus sign increases with a higher level of glucose, ketones, or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive). Urine samples were collected for the measurement of urinalysis parameters by dipstick method up-to follow-up (Day 25) in Part 1. Only categories with significant values have been presented. |
| Urine Potential of Hydrogen (pH) Analysis by Dipstick Method for Part 1 | Up to 25 days in Part 1 | Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Urine samples were collected for the measurement of urine pH by dipstick method up-to follow-up (Day 25) in Part 1. Only categories with significant values have been presented. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles). |
| Urine Specific Gravity Analysis by Dipstick Method for Part 1 | Up to 25 days in Part 1 | Urinary specific gravity measurement is a routine part of urinalysis. 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. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected for the measurement of urine specific gravity by dipstick method up-to follow-up (Day 25) in Part 1. Only categories with significant values have been presented. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles). |
| Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2 | Up to 36 days in Part 2 | Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood and urine protein. In this dipstick test, the level of ketones, glucose, occult blood and protein in urine samples was recorded as negative trace, 1+, 2+, and 3+ (the plus sign increases with a higher level of glucose, ketones, or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive). Urine samples were collected for the measurement of urinalysis parameters by dipstick method up-to follow-up (Day 36) in Part 2. Only categories with significant values have been presented. |
| AUC (0-t) of DTG for Part 2 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| Urine Specific Gravity Analysis by Dipstick Method for Part 2 | Up to 36 days in Part 2 | Urinary specific gravity measurement is a routine part of urinalysis. 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. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected for the measurement of urine specific gravity by dipstick method up-to follow-up (Day 36) in Part 2. Only categories with significant values have been presented. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). |
| Number of Participants With Chemistry Toxicities of Grade 2 as Defined by Division of Acquired Immunodeficiency Syndrome (DAIDS) for Part 1 | Up to 25 days in Part 1 | The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life threatening. low LDL (low-density lipid); HDL (high-density lipid). Data has been presented for clinical chemistry laboratory result parameter (serum sodium) with toxicity of Grade 2 for Part 1. |
| Number of Participants With Urinalysis Toxicities of Grade 2 as Defined by DAIDS for Part 1 | Up to 25 days in Part 1 | The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life threatening, low LDL and HDL Data has been presented for urinalysis laboratory result parameter (urine protein by dipstick analysis) with toxicity of Grade 2 for Part 1. |
| Urine pH Analysis by Dipstick Method for Part 2 | Up to 36 days in Part 2 | Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Urine samples were collected for the measurement of urine pH by dipstick method up-to follow-up (Day 36) in Part 2. Only categories with significant values have been presented. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles). |
| Cmax of DTG for Part 2 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| Plasma DTG Lag Time Before Observation of Drug Concentrations (Tlag) for Part 1 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| Time to First Occurrence of Cmax (Tmax) of DTG for Part 1 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 1 site in the United States of America from 03 May 2017 to 23 Jun 2017. The study was conducted in 2 parts and a total of 38 participants were enrolled: 14 in Part 1 (treatment A and B over 2 dosing periods) and 24 in Part 2 (treatment C,D,E, over 3 dosing periods) with washout of 7(-4 hours) days between doses.
Pre-assignment details
A total of 106 participants were screened however 68 were screen failures the reasons for which were did not meet inclusion/exclusion, adverse event, lost to follow up, investigator discretion, withdrew consent and screened but enrollment target reached prior to enrollment. All of the 38 enrolled participants completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Total Participants: Part 1 Participants in Part 1 of the study received each of 2 treatments Five 10 mg DTG tablets direct to mouth with 240 mL of water and One 50 mg DTG tablet direct to mouth with 240 mL of water over 2 Treatment periods. There was a washout of at least 7 (-4 hours) days between the Treatment Periods 1 and 2. | 14 |
| Total Participants: Part 2 Participants in Part 2, of the study received each of the 3 treatments Dispersible 5 mg DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1), Dispersible 5 mg DTG tablet (5 tablets) administered as direct to mouth (test 1) and Conventional 25-mg DTG tablet administered as direct to mouth \[reference\]) over 3 Treatment Periods. There was a washout of 7(-4 hours) days between the treatment periods 1, 2 and 3. | 24 |
| Total | 38 |
Baseline characteristics
| Characteristic | Total Participants: Part 2 | Total | Total Participants: Part 1 |
|---|---|---|---|
| Age, Continuous | 35.7 Years STANDARD_DEVIATION 9.71 | 34.9 Years STANDARD_DEVIATION 9.355 | 34.1 Years STANDARD_DEVIATION 9 |
| Race/Ethnicity, Customized Black or African American | 9 Participants | 13 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 15 Participants | 25 Participants | 10 Participants |
| Sex: Female, Male Female | 8 Participants | 17 Participants | 9 Participants |
| Sex: Female, Male Male | 16 Participants | 21 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 | 0 / 24 | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 1 / 14 | 2 / 14 | 2 / 24 | 2 / 24 | 3 / 24 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 | 0 / 24 | 0 / 24 | 0 / 24 |
Outcome results
Primary
Area Under the Plasma Concentration-time Curve From Time of Dose Extrapolated to Infinite Time (AUC[0-infinity]) of DTG for Part 1
Blood samples were collected at the indicated time points after administration of study treatment to investigate the pharmacokinetic (PK) profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. The PK Population was defined as participants in the All Subjects Population for whom a PK sample was obtained and that had evaluable PK assay results.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 10 mg | Area Under the Plasma Concentration-time Curve From Time of Dose Extrapolated to Infinite Time (AUC[0-infinity]) of DTG for Part 1 | 58900 hours*nanograms/mL (h*ng/mL) | Geometric Coefficient of Variation 37.2 |
| DTG 50 mg | Area Under the Plasma Concentration-time Curve From Time of Dose Extrapolated to Infinite Time (AUC[0-infinity]) of DTG for Part 1 | 58400 hours*nanograms/mL (h*ng/mL) | Geometric Coefficient of Variation 29.3 |
90% CI: [0.8626, 1.1789]
Primary
Area Under the Plasma Concentration-time Curve From Time of Dose to Last Measurable Concentration AUC [0-t] of DTG for Part 1
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times..
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 10 mg | Area Under the Plasma Concentration-time Curve From Time of Dose to Last Measurable Concentration AUC [0-t] of DTG for Part 1 | 55800 h*ng/mL | Geometric Coefficient of Variation 36.6 |
| DTG 50 mg | Area Under the Plasma Concentration-time Curve From Time of Dose to Last Measurable Concentration AUC [0-t] of DTG for Part 1 | 55200 h*ng/mL | Geometric Coefficient of Variation 27.3 |
90% CI: [0.8648, 1.1845]
Primary
AUC (0-infinity) of DTG for Part 2
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times..
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 10 mg | AUC (0-infinity) of DTG for Part 2 | 51300 h*ng/mL | Geometric Coefficient of Variation 18.8 |
| DTG 50 mg | AUC (0-infinity) of DTG for Part 2 | 48800 h*ng/mL | Geometric Coefficient of Variation 26.9 |
| DTG 25 mg (Reference) | AUC (0-infinity) of DTG for Part 2 | 31600 h*ng/mL | Geometric Coefficient of Variation 34.4 |
90% CI: [1.4986, 1.7604]
90% CI: [1.4253, 1.6743]
Primary
Maximum Observed Concentration (Cmax) of DTG for Part 1
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 10 mg | Maximum Observed Concentration (Cmax) of DTG for Part 1 | 2780 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 42.1 |
| DTG 50 mg | Maximum Observed Concentration (Cmax) of DTG for Part 1 | 2700 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 25.7 |
90% CI: [0.8623, 1.2373]
Secondary
Apparent Oral Clearance (CL/F) of DTG for Part 1
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times..
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 10 mg | Apparent Oral Clearance (CL/F) of DTG for Part 1 | 0.849 Liters/hour | Geometric Coefficient of Variation 37.2 |
| DTG 50 mg | Apparent Oral Clearance (CL/F) of DTG for Part 1 | 0.856 Liters/hour | Geometric Coefficient of Variation 29.3 |
Secondary
Apparent Volume of Distribution During the Terminal Phase (Vz/F) of DTG for Part 1
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 10 mg | Apparent Volume of Distribution During the Terminal Phase (Vz/F) of DTG for Part 1 | 19.4 Liters | Geometric Coefficient of Variation 39.2 |
| DTG 50 mg | Apparent Volume of Distribution During the Terminal Phase (Vz/F) of DTG for Part 1 | 20.0 Liters | Geometric Coefficient of Variation 22.8 |
Secondary
Area Under the Concentration-time Curve Over Time Zero (Pre-dose) to 24 Hours After Dose Administration (AUC[0-24]) of DTG for Part 1
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 10 mg | Area Under the Concentration-time Curve Over Time Zero (Pre-dose) to 24 Hours After Dose Administration (AUC[0-24]) of DTG for Part 1 | 37500 h*ng/mL | Geometric Coefficient of Variation 38.1 |
| DTG 50 mg | Area Under the Concentration-time Curve Over Time Zero (Pre-dose) to 24 Hours After Dose Administration (AUC[0-24]) of DTG for Part 1 | 36600 h*ng/mL | Geometric Coefficient of Variation 24.3 |
Secondary
AUC (0-24) of DTG for Part 2
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 10 mg | AUC (0-24) of DTG for Part 2 | 34000 h*ng/mL | Geometric Coefficient of Variation 16.1 |
| DTG 50 mg | AUC (0-24) of DTG for Part 2 | 32300 h*ng/mL | Geometric Coefficient of Variation 24.9 |
| DTG 25 mg (Reference) | AUC (0-24) of DTG for Part 2 | 20400 h*ng/mL | Geometric Coefficient of Variation 32.7 |
Secondary
AUC (0-t) of DTG for Part 2
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 10 mg | AUC (0-t) of DTG for Part 2 | 49000 h*ng/mL | Geometric Coefficient of Variation 17.5 |
| DTG 50 mg | AUC (0-t) of DTG for Part 2 | 46700 h*ng/mL | Geometric Coefficient of Variation 26 |
| DTG 25 mg (Reference) | AUC (0-t) of DTG for Part 2 | 30100 h*ng/mL | Geometric Coefficient of Variation 33.7 |
90% CI: [1.503, 1.7661]
90% CI: [1.4317, 1.6822]
Secondary
%AUCex of DTG for Part 2
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2
Population: PK Population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DTG 10 mg | %AUCex of DTG for Part 2 | 4.37 Percentage of AUC |
| DTG 50 mg | %AUCex of DTG for Part 2 | 4.23 Percentage of AUC |
| DTG 25 mg (Reference) | %AUCex of DTG for Part 2 | 4.66 Percentage of AUC |
Secondary
C24 of DTG for Part 2
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 10 mg | C24 of DTG for Part 2 | 770 ng/mL | Geometric Coefficient of Variation 19 |
| DTG 50 mg | C24 of DTG for Part 2 | 741 ng/mL | Geometric Coefficient of Variation 26.9 |
| DTG 25 mg (Reference) | C24 of DTG for Part 2 | 493 ng/mL | Geometric Coefficient of Variation 36 |
Secondary
Change From Baseline in Clinical Chemistry Parameters Serum Alanine Amino Transferase (ALT), Serum Alkaline Phosphatase, Serum Aspartate Amino Transferase (AST), Serum Creatine Kinase for Part 1
Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum ALT, serum alkaline phosphatase, serum AST, serum creatine kinase results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time frame: Baseline and up to 25 days in Part 1
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Alanine Amino Transferase (ALT), Serum Alkaline Phosphatase, Serum Aspartate Amino Transferase (AST), Serum Creatine Kinase for Part 1 | Serum ALT, Day 2, n=14, 14 | 0.8 International units/liter (IU/L) | Standard Deviation 6.29 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Alanine Amino Transferase (ALT), Serum Alkaline Phosphatase, Serum Aspartate Amino Transferase (AST), Serum Creatine Kinase for Part 1 | Serum ALT, Follow-up, n=5, 5 | -1.6 International units/liter (IU/L) | Standard Deviation 3.58 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Alanine Amino Transferase (ALT), Serum Alkaline Phosphatase, Serum Aspartate Amino Transferase (AST), Serum Creatine Kinase for Part 1 | Serum alkaline phosphatase, Day 2, n=14, 14 | 1.5 International units/liter (IU/L) | Standard Deviation 3.98 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Alanine Amino Transferase (ALT), Serum Alkaline Phosphatase, Serum Aspartate Amino Transferase (AST), Serum Creatine Kinase for Part 1 | Serum alkaline phosphatase, Follow-up, n=5, 5 | 1.4 International units/liter (IU/L) | Standard Deviation 2.19 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Alanine Amino Transferase (ALT), Serum Alkaline Phosphatase, Serum Aspartate Amino Transferase (AST), Serum Creatine Kinase for Part 1 | Serum AST, Day 2, n=14, 14 | 0.6 International units/liter (IU/L) | Standard Deviation 4.88 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Alanine Amino Transferase (ALT), Serum Alkaline Phosphatase, Serum Aspartate Amino Transferase (AST), Serum Creatine Kinase for Part 1 | Serum AST, Follow-up, n=5, 5 | -1.0 International units/liter (IU/L) | Standard Deviation 3.32 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Alanine Amino Transferase (ALT), Serum Alkaline Phosphatase, Serum Aspartate Amino Transferase (AST), Serum Creatine Kinase for Part 1 | Serum creatine kinase, Day 2, n=14, 14 | -43.6 International units/liter (IU/L) | Standard Deviation 64.32 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Alanine Amino Transferase (ALT), Serum Alkaline Phosphatase, Serum Aspartate Amino Transferase (AST), Serum Creatine Kinase for Part 1 | Serum creatine kinase, Follow-up, n=5, 5 | -17.2 International units/liter (IU/L) | Standard Deviation 33.21 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Alanine Amino Transferase (ALT), Serum Alkaline Phosphatase, Serum Aspartate Amino Transferase (AST), Serum Creatine Kinase for Part 1 | Serum creatine kinase, Follow-up, n=5, 5 | 0.8 International units/liter (IU/L) | Standard Deviation 22.75 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Alanine Amino Transferase (ALT), Serum Alkaline Phosphatase, Serum Aspartate Amino Transferase (AST), Serum Creatine Kinase for Part 1 | Serum ALT, Day 2, n=14, 14 | -1.1 International units/liter (IU/L) | Standard Deviation 2.18 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Alanine Amino Transferase (ALT), Serum Alkaline Phosphatase, Serum Aspartate Amino Transferase (AST), Serum Creatine Kinase for Part 1 | Serum AST, Day 2, n=14, 14 | -0.9 International units/liter (IU/L) | Standard Deviation 1.29 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Alanine Amino Transferase (ALT), Serum Alkaline Phosphatase, Serum Aspartate Amino Transferase (AST), Serum Creatine Kinase for Part 1 | Serum ALT, Follow-up, n=5, 5 | -1.0 International units/liter (IU/L) | Standard Deviation 2 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Alanine Amino Transferase (ALT), Serum Alkaline Phosphatase, Serum Aspartate Amino Transferase (AST), Serum Creatine Kinase for Part 1 | Serum creatine kinase, Day 2, n=14, 14 | -37.1 International units/liter (IU/L) | Standard Deviation 52.19 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Alanine Amino Transferase (ALT), Serum Alkaline Phosphatase, Serum Aspartate Amino Transferase (AST), Serum Creatine Kinase for Part 1 | Serum alkaline phosphatase, Day 2, n=14, 14 | 0.8 International units/liter (IU/L) | Standard Deviation 3.12 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Alanine Amino Transferase (ALT), Serum Alkaline Phosphatase, Serum Aspartate Amino Transferase (AST), Serum Creatine Kinase for Part 1 | Serum AST, Follow-up, n=5, 5 | 0.6 International units/liter (IU/L) | Standard Deviation 0.89 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Alanine Amino Transferase (ALT), Serum Alkaline Phosphatase, Serum Aspartate Amino Transferase (AST), Serum Creatine Kinase for Part 1 | Serum alkaline phosphatase, Follow-up, n=5, 5 | 1.0 International units/liter (IU/L) | Standard Deviation 5 |
Secondary
Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1
Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum albumin and serum protein results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time frame: Baseline and up to 25 days in Part 1
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1 | Serum Albumin, Day 2, n=14, 14 | 0.3 Grams/liter (g/L) | Standard Deviation 1.94 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1 | Serum Albumin, Follow-up, n=5, 5 | -1.2 Grams/liter (g/L) | Standard Deviation 1.3 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1 | Serum Protein, Day 2, n=14, 14 | 2.3 Grams/liter (g/L) | Standard Deviation 3.83 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1 | Serum Protein, Follow-up, n=5, 5 | 0.8 Grams/liter (g/L) | Standard Deviation 1.79 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1 | Serum Protein, Follow-up, n=5, 5 | 1.8 Grams/liter (g/L) | Standard Deviation 3.27 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1 | Serum Albumin, Day 2, n=14, 14 | 0.1 Grams/liter (g/L) | Standard Deviation 1.79 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1 | Serum Protein, Day 2, n=14, 14 | 2.4 Grams/liter (g/L) | Standard Deviation 3.76 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1 | Serum Albumin, Follow-up, n=5, 5 | -0.4 Grams/liter (g/L) | Standard Deviation 1.82 |
Secondary
Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2
Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum albumin and serum protein results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time frame: Baseline and up to 36 days in Part 2
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2 | Serum Protein, Day 2, n=24, 24, 24 | 2.3 g/L | Standard Deviation 3.29 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2 | Serum Protein, Follow-up, n=3, 2, 3 | 1.7 g/L | Standard Deviation 3.06 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2 | Serum Albumin, Follow-up, n=3, 2, 3 | 2.0 g/L | Standard Deviation 1.73 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2 | Serum Albumin, Day 2, n=24, 24, 24 | 0.4 g/L | Standard Deviation 2.22 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2 | Serum Protein, Day 2, n=24, 24, 24 | 3.2 g/L | Standard Deviation 3.48 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2 | Serum Protein, Follow-up, n=3, 2, 3 | -4.0 g/L | Standard Deviation 7.07 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2 | Serum Albumin, Follow-up, n=3, 2, 3 | -1.0 g/L | Standard Deviation 4.24 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2 | Serum Albumin, Day 2, n=24, 24, 24 | 1.1 g/L | Standard Deviation 2.24 |
| DTG 25 mg (Reference) | Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2 | Serum Protein, Follow-up, n=3, 2, 3 | 0.3 g/L | Standard Deviation 1.15 |
| DTG 25 mg (Reference) | Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2 | Serum Albumin, Day 2, n=24, 24, 24 | 0.5 g/L | Standard Deviation 2.47 |
| DTG 25 mg (Reference) | Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2 | Serum Albumin, Follow-up, n=3, 2, 3 | 1.7 g/L | Standard Deviation 0.58 |
| DTG 25 mg (Reference) | Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2 | Serum Protein, Day 2, n=24, 24, 24 | 2.7 g/L | Standard Deviation 3.83 |
Secondary
Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2
Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum ALT, serum alkaline phosphatase, serum AST, serum creatine kinase results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time frame: Baseline and up to 36 days in Part 2
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2 | Serum ALT, Day 2, n=24, 24, 24 | -0.4 IU/L | Standard Deviation 1.72 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2 | Serum ALT, Follow-up, n=3, 2, 3 | 2.0 IU/L | Standard Deviation 1.73 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2 | Serum alkaline phosphatase, Day 2, n=24, 24, 24 | 0.5 IU/L | Standard Deviation 3.39 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2 | Serum alkaline phosphatase, Follow-up, n=3, 2, 3 | 4.3 IU/L | Standard Deviation 2.52 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2 | Serum AST, Day 2, n=24, 24, 24 | -1.4 IU/L | Standard Deviation 2.72 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2 | Serum AST, Follow-up, n=3, 2, 3 | 0.0 IU/L | Standard Deviation 1 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2 | Serum Creatine kinase, Day 2, n=24, 24, 24 | -35.2 IU/L | Standard Deviation 67.19 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2 | Serum Creatine kinase, Follow-up, n=3, 2, 3 | -7.3 IU/L | Standard Deviation 18.04 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2 | Serum alkaline phosphatase, Day 2, n=24, 24, 24 | 1.8 IU/L | Standard Deviation 3.98 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2 | Serum Creatine kinase, Day 2, n=24, 24, 24 | -15.7 IU/L | Standard Deviation 37.79 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2 | Serum alkaline phosphatase, Follow-up, n=3, 2, 3 | 1.0 IU/L | Standard Deviation 11.31 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2 | Serum AST, Day 2, n=24, 24, 24 | -0.7 IU/L | Standard Deviation 1.99 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2 | Serum AST, Follow-up, n=3, 2, 3 | -3.0 IU/L | Standard Deviation 1.41 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2 | Serum ALT, Day 2, n=24, 24, 24 | -1.0 IU/L | Standard Deviation 2.07 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2 | Serum ALT, Follow-up, n=3, 2, 3 | -1.0 IU/L | Standard Deviation 1.41 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2 | Serum Creatine kinase, Follow-up, n=3, 2, 3 | -10.5 IU/L | Standard Deviation 9.19 |
| DTG 25 mg (Reference) | Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2 | Serum alkaline phosphatase, Day 2, n=24, 24, 24 | 0.2 IU/L | Standard Deviation 5.1 |
| DTG 25 mg (Reference) | Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2 | Serum ALT, Follow-up, n=3, 2, 3 | 0.3 IU/L | Standard Deviation 2.08 |
| DTG 25 mg (Reference) | Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2 | Serum ALT, Day 2, n=24, 24, 24 | -1.1 IU/L | Standard Deviation 1.57 |
| DTG 25 mg (Reference) | Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2 | Serum alkaline phosphatase, Follow-up, n=3, 2, 3 | 2.3 IU/L | Standard Deviation 3.51 |
| DTG 25 mg (Reference) | Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2 | Serum Creatine kinase, Day 2, n=24, 24, 24 | -37.2 IU/L | Standard Deviation 42.81 |
| DTG 25 mg (Reference) | Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2 | Serum AST, Follow-up, n=3, 2, 3 | -0.3 IU/L | Standard Deviation 3.21 |
| DTG 25 mg (Reference) | Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2 | Serum AST, Day 2, n=24, 24, 24 | -1.3 IU/L | Standard Deviation 1.66 |
| DTG 25 mg (Reference) | Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2 | Serum Creatine kinase, Follow-up, n=3, 2, 3 | 23.3 IU/L | Standard Deviation 43.25 |
Secondary
Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatine and Serum Direct Bilirubin for Part 2
Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum bilirubin, serum creatine and serum direct bilirubin results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time frame: Baseline and up to 36 days in Part 2
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatine and Serum Direct Bilirubin for Part 2 | Serum Bilirubin, Day 2, n=24, 24, 24 | 2.26 umol/L | Standard Deviation 2.26 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatine and Serum Direct Bilirubin for Part 2 | Serum direct bilirubin, Follow-up, n=3, 2, 3 | -0.07 umol/L | Standard Deviation 0.153 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatine and Serum Direct Bilirubin for Part 2 | Serum Creatinine, Day 2, n=24, 24, 24 | 8.02 umol/L | Standard Deviation 4.817 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatine and Serum Direct Bilirubin for Part 2 | Serum Bilirubin, Follow-u, n=3, 2, 3 | 0.97 umol/L | Standard Deviation 1.553 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatine and Serum Direct Bilirubin for Part 2 | Serum Creatinine, Follow-u, n=3, 2, 3 | 2.33 umol/L | Standard Deviation 3.293 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatine and Serum Direct Bilirubin for Part 2 | Serum direct bilirubin, Day 2, n=24, 24, 24 | 0.33 umol/L | Standard Deviation 0.464 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatine and Serum Direct Bilirubin for Part 2 | Serum Bilirubin, Follow-u, n=3, 2, 3 | -0.80 umol/L | Standard Deviation 1.414 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatine and Serum Direct Bilirubin for Part 2 | Serum direct bilirubin, Day 2, n=24, 24, 24 | 0.26 umol/L | Standard Deviation 0.388 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatine and Serum Direct Bilirubin for Part 2 | Serum Bilirubin, Day 2, n=24, 24, 24 | 2.85 umol/L | Standard Deviation 2.14 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatine and Serum Direct Bilirubin for Part 2 | Serum Creatinine, Day 2, n=24, 24, 24 | 9.83 umol/L | Standard Deviation 4.184 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatine and Serum Direct Bilirubin for Part 2 | Serum direct bilirubin, Follow-up, n=3, 2, 3 | -0.45 umol/L | Standard Deviation 0.354 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatine and Serum Direct Bilirubin for Part 2 | Serum Creatinine, Follow-u, n=3, 2, 3 | -4.80 umol/L | Standard Deviation 1.838 |
| DTG 25 mg (Reference) | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatine and Serum Direct Bilirubin for Part 2 | Serum direct bilirubin, Follow-up, n=3, 2, 3 | 0.30 umol/L | Standard Deviation 0.529 |
| DTG 25 mg (Reference) | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatine and Serum Direct Bilirubin for Part 2 | Serum Bilirubin, Follow-u, n=3, 2, 3 | 3.07 umol/L | Standard Deviation 3.612 |
| DTG 25 mg (Reference) | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatine and Serum Direct Bilirubin for Part 2 | Serum Bilirubin, Day 2, n=24, 24, 24 | 2.91 umol/L | Standard Deviation 2.835 |
| DTG 25 mg (Reference) | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatine and Serum Direct Bilirubin for Part 2 | Serum Creatinine, Day 2, n=24, 24, 24 | 8.31 umol/L | Standard Deviation 4.218 |
| DTG 25 mg (Reference) | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatine and Serum Direct Bilirubin for Part 2 | Serum Creatinine, Follow-u, n=3, 2, 3 | -5.00 umol/L | Standard Deviation 6.539 |
| DTG 25 mg (Reference) | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatine and Serum Direct Bilirubin for Part 2 | Serum direct bilirubin, Day 2, n=24, 24, 24 | 0.36 umol/L | Standard Deviation 0.526 |
Secondary
Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1
Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum bilirubin, serum creatinine and serum direct bilirubin results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time frame: Baseline and up to 25 days in Part 1
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1 | Serum Bilirubin, Day 2, n=14, 14 | 3.29 micromoles/liter (umol/L) | Standard Deviation 3.673 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1 | Serum Bilirubin, Follow-u, n=5, 5 | 0.10 micromoles/liter (umol/L) | Standard Deviation 0.977 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1 | Serum Creatinine, Day 2, n=14, 14 | 9.91 micromoles/liter (umol/L) | Standard Deviation 5.791 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1 | Serum Creatinine, Follow-u, n=5, 5 | 4.58 micromoles/liter (umol/L) | Standard Deviation 4.289 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1 | Serum direct bilirubin, Day 2, n=14, 14 | 0.24 micromoles/liter (umol/L) | Standard Deviation 0.503 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1 | Serum direct bilirubin, Follow-up, n=5,5 | 0.10 micromoles/liter (umol/L) | Standard Deviation 0.141 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1 | Serum direct bilirubin, Day 2, n=14, 14 | 0.30 micromoles/liter (umol/L) | Standard Deviation 0.342 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1 | Serum Bilirubin, Day 2, n=14, 14 | 3.28 micromoles/liter (umol/L) | Standard Deviation 3.005 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1 | Serum Creatinine, Follow-u, n=5, 5 | 3.18 micromoles/liter (umol/L) | Standard Deviation 4.164 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1 | Serum Bilirubin, Follow-u, n=5, 5 | 2.16 micromoles/liter (umol/L) | Standard Deviation 3.109 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1 | Serum direct bilirubin, Follow-up, n=5,5 | 0.44 micromoles/liter (umol/L) | Standard Deviation 0.428 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1 | Serum Creatinine, Day 2, n=14, 14 | 11.19 micromoles/liter (umol/L) | Standard Deviation 3.522 |
Secondary
Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2
Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum glucose, serum calcium, serum potassium, serum sodium, serum urea results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time frame: Baseline and up to 36 days in Part 2
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Glucose, Day 2, n=24, 24, 24 | -0.220 mmol/L | Standard Deviation 0.3653 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Glucose, Follow-up, n=3, 2, 3 | 0.130 mmol/L | Standard Deviation 0.2506 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Calcium, Day 2, n=24, 24, 24 | 0.008 mmol/L | Standard Deviation 0.0908 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Calcium, Follow-up, n=3, 2, 3 | 0.087 mmol/L | Standard Deviation 0.0603 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Potassium, Day 2, n=24, 24, 24 | 0.00 mmol/L | Standard Deviation 0.277 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Potassium, Follow-up, n=3, 2, 3 | -0.03 mmol/L | Standard Deviation 0.208 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Sodium, Day 2, n=24, 24, 24 | -0.3 mmol/L | Standard Deviation 2.37 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Sodium, Follow-up, n=3, 2, 3 | 1.3 mmol/L | Standard Deviation 2.89 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Urea, Day 2, n=24, 24, 24 | -0.868 mmol/L | Standard Deviation 1.3581 |
| DTG 10 mg | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Urea, Follow-up, n=3, 2, 3 | 0.067 mmol/L | Standard Deviation 1.515 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Urea, Day 2, n=24, 24, 24 | -0.366 mmol/L | Standard Deviation 0.8349 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Glucose, Day 2, n=24, 24, 24 | -0.223 mmol/L | Standard Deviation 0.2715 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Potassium, Follow-up, n=3, 2, 3 | 0.05 mmol/L | Standard Deviation 0.212 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Potassium, Day 2, n=24, 24, 24 | 0.04 mmol/L | Standard Deviation 0.298 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Glucose, Follow-up, n=3, 2, 3 | -0.060 mmol/L | Standard Deviation 0.1556 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Urea, Follow-up, n=3, 2, 3 | -0.585 mmol/L | Standard Deviation 1.2374 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Sodium, Follow-up, n=3, 2, 3 | 0.5 mmol/L | Standard Deviation 0.71 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Calcium, Day 2, n=24, 24, 24 | 0.056 mmol/L | Standard Deviation 0.0901 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Sodium, Day 2, n=24, 24, 24 | 0.2 mmol/L | Standard Deviation 2.02 |
| DTG 50 mg | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Calcium, Follow-up, n=3, 2, 3 | -0.035 mmol/L | Standard Deviation 0.0919 |
| DTG 25 mg (Reference) | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Sodium, Follow-up, n=3, 2, 3 | 0.0 mmol/L | Standard Deviation 3.46 |
| DTG 25 mg (Reference) | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Calcium, Follow-up, n=3, 2, 3 | -0.010 mmol/L | Standard Deviation 0.0529 |
| DTG 25 mg (Reference) | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Potassium, Day 2, n=24, 24, 24 | 0.19 mmol/L | Standard Deviation 0.292 |
| DTG 25 mg (Reference) | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Potassium, Follow-up, n=3, 2, 3 | -0.27 mmol/L | Standard Deviation 0.208 |
| DTG 25 mg (Reference) | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Urea, Day 2, n=24, 24, 24 | -0.376 mmol/L | Standard Deviation 1.1319 |
| DTG 25 mg (Reference) | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Sodium, Day 2, n=24, 24, 24 | -0.4 mmol/L | Standard Deviation 2.62 |
| DTG 25 mg (Reference) | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Glucose, Day 2, n=24, 24, 24 | -0.187 mmol/L | Standard Deviation 0.3599 |
| DTG 25 mg (Reference) | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Urea, Follow-up, n=3, 2, 3 | -1.237 mmol/L | Standard Deviation 0.6561 |
| DTG 25 mg (Reference) | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Glucose, Follow-up, n=3, 2, 3 | -0.150 mmol/L | Standard Deviation 0.1559 |
| DTG 25 mg (Reference) | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Serum Calcium, Day 2, n=24, 24, 24 | 0.036 mmol/L | Standard Deviation 0.0827 |
Secondary
Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1
Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum glucose, serum calcium, serum potassium, serum sodium, serum urea results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time frame: Baseline and up to 25 days in Part 1
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 10 mg | Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1 | Serum glucose, Day 2, n=14, 14 | -0.091 millimoles/liter (mmol/L) | Standard Deviation 0.2796 |
| DTG 10 mg | Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1 | Serum glucose, Follow-up, n=5, 5 | -0.178 millimoles/liter (mmol/L) | Standard Deviation 0.5554 |
| DTG 10 mg | Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1 | Serum calcium, Day 2, n=14, 14 | 0.001 millimoles/liter (mmol/L) | Standard Deviation 0.0679 |
| DTG 10 mg | Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1 | Serum calcium, Follow-up, n=5, 5 | -0.024 millimoles/liter (mmol/L) | Standard Deviation 0.0764 |
| DTG 10 mg | Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1 | Serum Potassium, Day 2, n=14, 14 | 0.08 millimoles/liter (mmol/L) | Standard Deviation 0.258 |
| DTG 10 mg | Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1 | Serum Potassium, Follow-up, n=5, 5 | -0.26 millimoles/liter (mmol/L) | Standard Deviation 0.182 |
| DTG 10 mg | Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1 | Serum Sodium, Day 2, n=14, 14 | -1.3 millimoles/liter (mmol/L) | Standard Deviation 2.2 |
| DTG 10 mg | Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1 | Serum Sodium, Follow-up, n=5, 5 | -1.6 millimoles/liter (mmol/L) | Standard Deviation 1.14 |
| DTG 10 mg | Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1 | Serum Urea, Day 2, n=14, 14 | -0.394 millimoles/liter (mmol/L) | Standard Deviation 1.2216 |
| DTG 10 mg | Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1 | Serum Urea, Follow-up, n=5, 5 | 0.248 millimoles/liter (mmol/L) | Standard Deviation 1.6064 |
| DTG 50 mg | Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1 | Serum Sodium, Follow-up, n=5, 5 | -0.6 millimoles/liter (mmol/L) | Standard Deviation 1.82 |
| DTG 50 mg | Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1 | Serum glucose, Day 2, n=14, 14 | 0.071 millimoles/liter (mmol/L) | Standard Deviation 0.2641 |
| DTG 50 mg | Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1 | Serum Potassium, Follow-up, n=5, 5 | -0.26 millimoles/liter (mmol/L) | Standard Deviation 0.207 |
| DTG 50 mg | Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1 | Serum glucose, Follow-up, n=5, 5 | 0.022 millimoles/liter (mmol/L) | Standard Deviation 0.4315 |
| DTG 50 mg | Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1 | Serum Urea, Follow-up, n=5, 5 | -0.248 millimoles/liter (mmol/L) | Standard Deviation 1.6173 |
| DTG 50 mg | Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1 | Serum calcium, Day 2, n=14, 14 | -0.005 millimoles/liter (mmol/L) | Standard Deviation 0.0682 |
| DTG 50 mg | Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1 | Serum Sodium, Day 2, n=14, 14 | -0.7 millimoles/liter (mmol/L) | Standard Deviation 2.23 |
| DTG 50 mg | Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1 | Serum calcium, Follow-up, n=5, 5 | -0.044 millimoles/liter (mmol/L) | Standard Deviation 0.0537 |
| DTG 50 mg | Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1 | Serum Urea, Day 2, n=14, 14 | -0.444 millimoles/liter (mmol/L) | Standard Deviation 1.1499 |
| DTG 50 mg | Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1 | Serum Potassium, Day 2, n=14, 14 | 0.09 millimoles/liter (mmol/L) | Standard Deviation 0.3 |
Secondary
Change From Baseline in Hematology Parameter Blood Erythrocyte MCH for Part 2
Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocyte MCH results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles).
Time frame: Baseline and up to 36 days in Part 2
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 10 mg | Change From Baseline in Hematology Parameter Blood Erythrocyte MCH for Part 2 | Blood erythrocyte MCH, Day 2, n=24, 24, 24 | 0.12 pg | Standard Deviation 0.3 |
| DTG 10 mg | Change From Baseline in Hematology Parameter Blood Erythrocyte MCH for Part 2 | Blood erythrocyte MCH, Follow-up, n=3, 2, 3 | 0.03 pg | Standard Deviation 0.451 |
| DTG 50 mg | Change From Baseline in Hematology Parameter Blood Erythrocyte MCH for Part 2 | Blood erythrocyte MCH, Day 2, n=24, 24, 24 | 0.05 pg | Standard Deviation 0.292 |
| DTG 50 mg | Change From Baseline in Hematology Parameter Blood Erythrocyte MCH for Part 2 | Blood erythrocyte MCH, Follow-up, n=3, 2, 3 | -0.25 pg | Standard Deviation 0.212 |
| DTG 25 mg (Reference) | Change From Baseline in Hematology Parameter Blood Erythrocyte MCH for Part 2 | Blood erythrocyte MCH, Day 2, n=24, 24, 24 | 0.05 pg | Standard Deviation 0.26 |
| DTG 25 mg (Reference) | Change From Baseline in Hematology Parameter Blood Erythrocyte MCH for Part 2 | Blood erythrocyte MCH, Follow-up, n=3, 2, 3 | 0.03 pg | Standard Deviation 0.252 |
Secondary
Change From Baseline in Hematology Parameter Blood Erythrocyte MCV for Part 2
Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocyte MCV results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles).
Time frame: Baseline and up to 36 days in Part 2
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 10 mg | Change From Baseline in Hematology Parameter Blood Erythrocyte MCV for Part 2 | Blood erythrocyte MCV, Day 2, n=24, 24, 24 | -0.03 fL | Standard Deviation 0.766 |
| DTG 10 mg | Change From Baseline in Hematology Parameter Blood Erythrocyte MCV for Part 2 | Blood erythrocyte MCV, Follow-up, n=3, 2, 3 | 0.07 fL | Standard Deviation 1.069 |
| DTG 50 mg | Change From Baseline in Hematology Parameter Blood Erythrocyte MCV for Part 2 | Blood erythrocyte MCV, Day 2, n=24, 24, 24 | -0.13 fL | Standard Deviation 0.761 |
| DTG 50 mg | Change From Baseline in Hematology Parameter Blood Erythrocyte MCV for Part 2 | Blood erythrocyte MCV, Follow-up, n=3, 2, 3 | -0.25 fL | Standard Deviation 0.212 |
| DTG 25 mg (Reference) | Change From Baseline in Hematology Parameter Blood Erythrocyte MCV for Part 2 | Blood erythrocyte MCV, Day 2, n=24, 24, 24 | 0.29 fL | Standard Deviation 0.729 |
| DTG 25 mg (Reference) | Change From Baseline in Hematology Parameter Blood Erythrocyte MCV for Part 2 | Blood erythrocyte MCV, Follow-up, n=3, 2, 3 | -0.20 fL | Standard Deviation 0.1 |
Secondary
Change From Baseline in Hematology Parameter Blood Erythrocyte Mean Corpuscular Hemoglobin (MCH) for Part 1
Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocyte MCH results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time frame: Baseline and up to 25 days in Part 1
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 10 mg | Change From Baseline in Hematology Parameter Blood Erythrocyte Mean Corpuscular Hemoglobin (MCH) for Part 1 | Blood erythrocyte MCH, Day 2, n=14, 14 | 0.08 Picograms (pg) | Standard Deviation 0.426 |
| DTG 10 mg | Change From Baseline in Hematology Parameter Blood Erythrocyte Mean Corpuscular Hemoglobin (MCH) for Part 1 | Blood erythrocyte MCH, Follow-up, n=5, 5 | 0.00 Picograms (pg) | Standard Deviation 0.292 |
| DTG 50 mg | Change From Baseline in Hematology Parameter Blood Erythrocyte Mean Corpuscular Hemoglobin (MCH) for Part 1 | Blood erythrocyte MCH, Day 2, n=14, 14 | -0.02 Picograms (pg) | Standard Deviation 0.283 |
| DTG 50 mg | Change From Baseline in Hematology Parameter Blood Erythrocyte Mean Corpuscular Hemoglobin (MCH) for Part 1 | Blood erythrocyte MCH, Follow-up, n=5, 5 | -0.22 Picograms (pg) | Standard Deviation 0.286 |
Secondary
Change From Baseline in Hematology Parameter Blood Erythrocyte Mean Corpuscular Volume (MCV) for Part 1
Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocyte MCV results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles).
Time frame: Baseline and up to 25 days in Part 1
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 10 mg | Change From Baseline in Hematology Parameter Blood Erythrocyte Mean Corpuscular Volume (MCV) for Part 1 | Blood erythrocyte MCV, Day 2, n=14, 14 | -0.01 Femtoliters (fL) | Standard Deviation 0.598 |
| DTG 10 mg | Change From Baseline in Hematology Parameter Blood Erythrocyte Mean Corpuscular Volume (MCV) for Part 1 | Blood erythrocyte MCV, Follow-up, n=5,5 | -0.38 Femtoliters (fL) | Standard Deviation 0.277 |
| DTG 50 mg | Change From Baseline in Hematology Parameter Blood Erythrocyte Mean Corpuscular Volume (MCV) for Part 1 | Blood erythrocyte MCV, Day 2, n=14, 14 | 0.26 Femtoliters (fL) | Standard Deviation 0.418 |
| DTG 50 mg | Change From Baseline in Hematology Parameter Blood Erythrocyte Mean Corpuscular Volume (MCV) for Part 1 | Blood erythrocyte MCV, Follow-up, n=5,5 | 0.26 Femtoliters (fL) | Standard Deviation 0.416 |
Secondary
Change From Baseline in Hematology Parameter Blood Erythrocytes for Part 1
Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocyte results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles).
Time frame: Baseline and up to 25 days in Part 1
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 10 mg | Change From Baseline in Hematology Parameter Blood Erythrocytes for Part 1 | Blood erythrocytes, Day 2, n=14, 14 | 0.182 10^12 cells/Liter | Standard Deviation 0.1679 |
| DTG 10 mg | Change From Baseline in Hematology Parameter Blood Erythrocytes for Part 1 | Blood erythrocyte, Follow-up, n=5, 5 | -0.024 10^12 cells/Liter | Standard Deviation 0.1638 |
| DTG 50 mg | Change From Baseline in Hematology Parameter Blood Erythrocytes for Part 1 | Blood erythrocytes, Day 2, n=14, 14 | 0.193 10^12 cells/Liter | Standard Deviation 0.1616 |
| DTG 50 mg | Change From Baseline in Hematology Parameter Blood Erythrocytes for Part 1 | Blood erythrocyte, Follow-up, n=5, 5 | -0.014 10^12 cells/Liter | Standard Deviation 0.2812 |
Secondary
Change From Baseline in Hematology Parameter Blood Erythrocytes for Part 2
Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocytes results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles).
Time frame: Baseline and up to 36 days in Part 2
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 10 mg | Change From Baseline in Hematology Parameter Blood Erythrocytes for Part 2 | Blood erythrocytes, Day 2, n=24, 24, 24 | 0.145 10^12 cells/Liter | Standard Deviation 0.2039 |
| DTG 10 mg | Change From Baseline in Hematology Parameter Blood Erythrocytes for Part 2 | Blood erythrocyte, Follow-up, n=3, 2, 3 | 0.123 10^12 cells/Liter | Standard Deviation 0.2173 |
| DTG 50 mg | Change From Baseline in Hematology Parameter Blood Erythrocytes for Part 2 | Blood erythrocyte, Follow-up, n=3, 2, 3 | 0.120 10^12 cells/Liter | Standard Deviation 0.1838 |
| DTG 50 mg | Change From Baseline in Hematology Parameter Blood Erythrocytes for Part 2 | Blood erythrocytes, Day 2, n=24, 24, 24 | 0.209 10^12 cells/Liter | Standard Deviation 0.173 |
| DTG 25 mg (Reference) | Change From Baseline in Hematology Parameter Blood Erythrocytes for Part 2 | Blood erythrocytes, Day 2, n=24, 24, 24 | 0.165 10^12 cells/Liter | Standard Deviation 0.2311 |
| DTG 25 mg (Reference) | Change From Baseline in Hematology Parameter Blood Erythrocytes for Part 2 | Blood erythrocyte, Follow-up, n=3, 2, 3 | 0.117 10^12 cells/Liter | Standard Deviation 0.0907 |
Secondary
Change From Baseline in Hematology Parameter Blood Hematocrit for Part 1
Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood hematocrit results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles).
Time frame: Baseline and up to 25 days in Part 1
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 10 mg | Change From Baseline in Hematology Parameter Blood Hematocrit for Part 1 | Blood hematocrit, Day 2, n=14, 14 | 0.0137 Proportion of red blood cells in blood | Standard Deviation 0.01585 |
| DTG 10 mg | Change From Baseline in Hematology Parameter Blood Hematocrit for Part 1 | Blood hematocrit, Follow-up, n=5, 5 | -0.0042 Proportion of red blood cells in blood | Standard Deviation 0.01462 |
| DTG 50 mg | Change From Baseline in Hematology Parameter Blood Hematocrit for Part 1 | Blood hematocrit, Day 2, n=14, 14 | 0.0131 Proportion of red blood cells in blood | Standard Deviation 0.01353 |
| DTG 50 mg | Change From Baseline in Hematology Parameter Blood Hematocrit for Part 1 | Blood hematocrit, Follow-up, n=5, 5 | -0.0058 Proportion of red blood cells in blood | Standard Deviation 0.01878 |
Secondary
Change From Baseline in Hematology Parameter Blood Hematocrit for Part 2
Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood hematocrit results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles)
Time frame: Baseline and up to 36 days in Part 2
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 10 mg | Change From Baseline in Hematology Parameter Blood Hematocrit for Part 2 | Blood hematocrit, Day 2, n=24, 24, 24 | 0.0126 Proportion of red blood cells in blood | Standard Deviation 0.01745 |
| DTG 10 mg | Change From Baseline in Hematology Parameter Blood Hematocrit for Part 2 | Blood hematocrit, Follow-up, n=3, 2, 3 | 0.0113 Proportion of red blood cells in blood | Standard Deviation 0.02043 |
| DTG 50 mg | Change From Baseline in Hematology Parameter Blood Hematocrit for Part 2 | Blood hematocrit, Day 2, n=24, 24, 24 | 0.0172 Proportion of red blood cells in blood | Standard Deviation 0.0166 |
| DTG 50 mg | Change From Baseline in Hematology Parameter Blood Hematocrit for Part 2 | Blood hematocrit, Follow-up, n=3, 2, 3 | 0.0090 Proportion of red blood cells in blood | Standard Deviation 0.01697 |
| DTG 25 mg (Reference) | Change From Baseline in Hematology Parameter Blood Hematocrit for Part 2 | Blood hematocrit, Day 2, n=24, 24, 24 | 0.0158 Proportion of red blood cells in blood | Standard Deviation 0.01994 |
| DTG 25 mg (Reference) | Change From Baseline in Hematology Parameter Blood Hematocrit for Part 2 | Blood hematocrit, Follow-up, n=3, 2, 3 | 0.0103 Proportion of red blood cells in blood | Standard Deviation 0.00802 |
Secondary
Change From Baseline in Hematology Parameter Blood Hemoglobin for Part 1
Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood hemoglobin results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles)
Time frame: Baseline and up to 25 days in Part 1
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 10 mg | Change From Baseline in Hematology Parameter Blood Hemoglobin for Part 1 | Blood hemoglobin, Day 2, n=14, 14 | 4.9 g/L | Standard Deviation 4.36 |
| DTG 10 mg | Change From Baseline in Hematology Parameter Blood Hemoglobin for Part 1 | Blood hemoglobin, Follow-up, n=5, 5 | -0.8 g/L | Standard Deviation 5.5 |
| DTG 50 mg | Change From Baseline in Hematology Parameter Blood Hemoglobin for Part 1 | Blood hemoglobin, Day 2, n=14, 14 | 4.0 g/L | Standard Deviation 5.14 |
| DTG 50 mg | Change From Baseline in Hematology Parameter Blood Hemoglobin for Part 1 | Blood hemoglobin, Follow-up, n=5, 5 | -3.4 g/L | Standard Deviation 5.98 |
Secondary
Change From Baseline in Hematology Parameter Blood Hemoglobin for Part 2
Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood hemoglobin results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles)
Time frame: Baseline and up to 36 days in Part 2
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 10 mg | Change From Baseline in Hematology Parameter Blood Hemoglobin for Part 2 | Blood hemoglobin, Day 2, n=24, 24, 24 | 5.0 g/L | Standard Deviation 5.56 |
| DTG 10 mg | Change From Baseline in Hematology Parameter Blood Hemoglobin for Part 2 | Blood hemoglobin, Follow-up, n=3, 2, 3 | 3.7 g/L | Standard Deviation 5.69 |
| DTG 50 mg | Change From Baseline in Hematology Parameter Blood Hemoglobin for Part 2 | Blood hemoglobin, Day 2, n=24, 24, 24 | 6.3 g/L | Standard Deviation 5.12 |
| DTG 50 mg | Change From Baseline in Hematology Parameter Blood Hemoglobin for Part 2 | Blood hemoglobin, Follow-up, n=3, 2, 3 | 2.0 g/L | Standard Deviation 5.66 |
| DTG 25 mg (Reference) | Change From Baseline in Hematology Parameter Blood Hemoglobin for Part 2 | Blood hemoglobin, Day 2, n=24, 24, 24 | 4.8 g/L | Standard Deviation 6.65 |
| DTG 25 mg (Reference) | Change From Baseline in Hematology Parameter Blood Hemoglobin for Part 2 | Blood hemoglobin, Follow-up, n=3, 2, 3 | 3.7 g/L | Standard Deviation 2.31 |
Secondary
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1
Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils, blood platelets results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles)
Time frame: Baseline and up to 25 days in Part 1
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 10 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Blood leukocytes, Follow-up, n=5, 5 | -0.06 10^9 cells/Liter | Standard Deviation 0.853 |
| DTG 10 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Blood monocytes, Follow-up, n=5, 5 | -0.036 10^9 cells/Liter | Standard Deviation 0.074 |
| DTG 10 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Blood lymphocytes, Day 2, n=14, 14 | 0.018 10^9 cells/Liter | Standard Deviation 0.2404 |
| DTG 10 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Blood basophils, Follow-up, n=5, 5 | -0.004 10^9 cells/Liter | Standard Deviation 0.0195 |
| DTG 10 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Blood lymphocytes, Follow-up, n=5, 5 | 0.022 10^9 cells/Liter | Standard Deviation 0.1894 |
| DTG 10 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Blood eosinophils, Day 2, n=14, 14 | 0.003 10^9 cells/Liter | Standard Deviation 0.0324 |
| DTG 10 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Blood eosinophils, Follow-up, n=5, 5 | -0.002 10^9 cells/Liter | Standard Deviation 0.0164 |
| DTG 10 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Blood neutrophils, Day 2, n=14, 14 | -0.317 10^9 cells/Liter | Standard Deviation 0.3704 |
| DTG 10 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Blood monocytes, Day 2, n=14, 14 | -0.031 10^9 cells/Liter | Standard Deviation 0.0611 |
| DTG 10 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Blood neutrophils, Follow-up, n=5, 5 | -0.062 10^9 cells/Liter | Standard Deviation 0.6518 |
| DTG 10 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Blood platelets, Day 2, n=14, 14 | 14.0 10^9 cells/Liter | Standard Deviation 15.56 |
| DTG 10 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Blood leukocytes, Day 2, n=14, 14 | -0.33 10^9 cells/Liter | Standard Deviation 0.574 |
| DTG 10 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Blood platelets, Follow-up, n=5, 5 | -11.2 10^9 cells/Liter | Standard Deviation 11.12 |
| DTG 10 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Blood basophils, Day 2, n=14, 14 | -0.004 10^9 cells/Liter | Standard Deviation 0.0101 |
| DTG 50 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Blood platelets, Follow-up, n=5, 5 | 11.0 10^9 cells/Liter | Standard Deviation 29.56 |
| DTG 50 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Blood eosinophils, Day 2, n=14, 14 | -0.014 10^9 cells/Liter | Standard Deviation 0.0527 |
| DTG 50 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Blood lymphocytes, Follow-up, n=5, 5 | 0.130 10^9 cells/Liter | Standard Deviation 0.4077 |
| DTG 50 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Blood neutrophils, Follow-up, n=5, 5 | -0.264 10^9 cells/Liter | Standard Deviation 0.3824 |
| DTG 50 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Blood basophils, Day 2, n=14, 14 | -0.013 10^9 cells/Liter | Standard Deviation 0.023 |
| DTG 50 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Blood eosinophils, Follow-up, n=5, 5 | -0.072 10^9 cells/Liter | Standard Deviation 0.1666 |
| DTG 50 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Blood leukocytes, Day 2, n=14, 14 | -0.54 10^9 cells/Liter | Standard Deviation 0.633 |
| DTG 50 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Blood leukocytes, Follow-up, n=5, 5 | -0.26 10^9 cells/Liter | Standard Deviation 0.631 |
| DTG 50 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Blood lymphocytes, Day 2, n=14, 14 | 0.049 10^9 cells/Liter | Standard Deviation 0.5629 |
| DTG 50 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Blood monocytes, Day 2, n=14, 14 | -0.064 10^9 cells/Liter | Standard Deviation 0.0773 |
| DTG 50 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Blood monocytes, Follow-up, n=5, 5 | -0.040 10^9 cells/Liter | Standard Deviation 0.1279 |
| DTG 50 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Blood neutrophils, Day 2, n=14, 14 | -0.486 10^9 cells/Liter | Standard Deviation 0.4733 |
| DTG 50 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Blood platelets, Day 2, n=14, 14 | 12.6 10^9 cells/Liter | Standard Deviation 18.21 |
| DTG 50 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Blood basophils, Follow-up, n=5, 5 | -0.004 10^9 cells/Liter | Standard Deviation 0.023 |
Secondary
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2
Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils, blood platelets results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles)
Time frame: Baseline and up to 36 days in Part 2
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 10 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood leukocytes, Day 2, n=24, 24, 24 | -0.58 10^9 cells/Liter | Standard Deviation 0.925 |
| DTG 10 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood basophils, Day 2, n=24, 24, 24 | -0.004 10^9 cells/Liter | Standard Deviation 0.0088 |
| DTG 10 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood monocytes, Day 2, n=24, 24, 24 | -0.085 10^9 cells/Liter | Standard Deviation 0.086 |
| DTG 10 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood leukocytes, Follow-up, n=3, 2, 3 | -0.63 10^9 cells/Liter | Standard Deviation 1.823 |
| DTG 10 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood platelets, Day 2, n=24, 24, 24 | 7.4 10^9 cells/Liter | Standard Deviation 15.81 |
| DTG 10 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood lymphocytes, Follow-up, n=3, 2, 3 | -0.130 10^9 cells/Liter | Standard Deviation 0.5603 |
| DTG 10 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood lymphocytes, Day 2, n=24, 24, 24 | -0.057 10^9 cells/Liter | Standard Deviation 0.2571 |
| DTG 10 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood monocytes, Follow-up, n=3, 2, 3 | -0.093 10^9 cells/Liter | Standard Deviation 0.2558 |
| DTG 10 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood eosinophils, Day 2, n=24, 24, 24 | -0.028 10^9 cells/Liter | Standard Deviation 0.0478 |
| DTG 10 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood platelets, Follow-up, n=3, 2, 3 | 18.0 10^9 cells/Liter | Standard Deviation 11.14 |
| DTG 10 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood neutrophils, Follow-up, n=3, 2, 3 | -0.350 10^9 cells/Liter | Standard Deviation 0.956 |
| DTG 10 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood eosinophils, Follow-up, n=3, 2, 3 | -0.060 10^9 cells/Liter | Standard Deviation 0.1253 |
| DTG 10 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood basophils, Follow-up, n=3, 2, 3 | 0.003 10^9 cells/Liter | Standard Deviation 0.0058 |
| DTG 10 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood neutrophils, Day 2, n=24, 24, 24 | -0.398 10^9 cells/Liter | Standard Deviation 0.8425 |
| DTG 50 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood lymphocytes, Day 2, n=24, 24, 24 | -0.105 10^9 cells/Liter | Standard Deviation 0.3268 |
| DTG 50 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood platelets, Follow-up, n=3, 2, 3 | 11.0 10^9 cells/Liter | Standard Deviation 29.7 |
| DTG 50 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood basophils, Day 2, n=24, 24, 24 | -0.005 10^9 cells/Liter | Standard Deviation 0.0128 |
| DTG 50 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood basophils, Follow-up, n=3, 2, 3 | 0.000 10^9 cells/Liter | Standard Deviation 0 |
| DTG 50 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood eosinophils, Day 2, n=24, 24, 24 | -0.024 10^9 cells/Liter | Standard Deviation 0.046 |
| DTG 50 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood eosinophils, Follow-up, n=3, 2, 3 | 0.015 10^9 cells/Liter | Standard Deviation 0.0778 |
| DTG 50 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood leukocytes, Day 2, n=24, 24, 24 | -0.75 10^9 cells/Liter | Standard Deviation 1.097 |
| DTG 50 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood leukocytes, Follow-up, n=3, 2, 3 | -2.05 10^9 cells/Liter | Standard Deviation 0.636 |
| DTG 50 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood lymphocytes, Follow-up, n=3, 2, 3 | 0.245 10^9 cells/Liter | Standard Deviation 0.2616 |
| DTG 50 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood monocytes, Day 2, n=24, 24, 24 | -0.084 10^9 cells/Liter | Standard Deviation 0.0941 |
| DTG 50 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood monocytes, Follow-up, n=3, 2, 3 | -0.060 10^9 cells/Liter | Standard Deviation 0.1273 |
| DTG 50 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood neutrophils, Day 2, n=24, 24, 24 | -0.520 10^9 cells/Liter | Standard Deviation 1.025 |
| DTG 50 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood neutrophils, Follow-up, n=3, 2, 3 | -2.225 10^9 cells/Liter | Standard Deviation 0.0919 |
| DTG 50 mg | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood platelets, Day 2, n=24, 24, 24 | 12.9 10^9 cells/Liter | Standard Deviation 15.73 |
| DTG 25 mg (Reference) | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood monocytes, Day 2, n=24, 24, 24 | -0.104 10^9 cells/Liter | Standard Deviation 0.1401 |
| DTG 25 mg (Reference) | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood platelets, Follow-up, n=3, 2, 3 | 12.3 10^9 cells/Liter | Standard Deviation 17.16 |
| DTG 25 mg (Reference) | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood monocytes, Follow-up, n=3, 2, 3 | 0.033 10^9 cells/Liter | Standard Deviation 0.0513 |
| DTG 25 mg (Reference) | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood eosinophils, Follow-up, n=3, 2, 3 | -0.020 10^9 cells/Liter | Standard Deviation 0.0436 |
| DTG 25 mg (Reference) | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood platelets, Day 2, n=24, 24, 24 | 7.8 10^9 cells/Liter | Standard Deviation 14.96 |
| DTG 25 mg (Reference) | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood neutrophils, Day 2, n=24, 24, 24 | -0.477 10^9 cells/Liter | Standard Deviation 0.8127 |
| DTG 25 mg (Reference) | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood eosinophils, Day 2, n=24, 24, 24 | -0.019 10^9 cells/Liter | Standard Deviation 0.0482 |
| DTG 25 mg (Reference) | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood basophils, Day 2, n=24, 24, 24 | -0.004 10^9 cells/Liter | Standard Deviation 0.0166 |
| DTG 25 mg (Reference) | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood lymphocytes, Day 2, n=24, 24, 24 | -0.196 10^9 cells/Liter | Standard Deviation 0.3254 |
| DTG 25 mg (Reference) | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood leukocytes, Follow-up, n=3, 2, 3 | -0.23 10^9 cells/Liter | Standard Deviation 0.643 |
| DTG 25 mg (Reference) | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood neutrophils, Follow-up, n=3, 2, 3 | -0.563 10^9 cells/Liter | Standard Deviation 0.4179 |
| DTG 25 mg (Reference) | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood lymphocytes, Follow-up, n=3, 2, 3 | 0.293 10^9 cells/Liter | Standard Deviation 0.2919 |
| DTG 25 mg (Reference) | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood leukocytes, Day 2, n=24, 24, 24 | -0.98 10^9 cells/Liter | Standard Deviation 1.208 |
| DTG 25 mg (Reference) | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood basophils, Follow-up, n=3, 2, 3 | 0.000 10^9 cells/Liter | Standard Deviation 0.01 |
Secondary
Cmax of DTG for Part 2
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 10 mg | Cmax of DTG for Part 2 | 2690 ng/mL | Geometric Coefficient of Variation 24.2 |
| DTG 50 mg | Cmax of DTG for Part 2 | 2700 ng/mL | Geometric Coefficient of Variation 31.5 |
| DTG 25 mg (Reference) | Cmax of DTG for Part 2 | 1500 ng/mL | Geometric Coefficient of Variation 34.2 |
90% CI: [1.6226, 1.9819]
90% CI: [1.6263, 1.9865]
Secondary
Ct of DTG for Part 2
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 10 mg | Ct of DTG for Part 2 | 89.3 ng/mL | Geometric Coefficient of Variation 45.7 |
| DTG 50 mg | Ct of DTG for Part 2 | 84.4 ng/mL | Geometric Coefficient of Variation 48 |
| DTG 25 mg (Reference) | Ct of DTG for Part 2 | 58.2 ng/mL | Geometric Coefficient of Variation 54.7 |
Secondary
DTG CL/F for Part 2
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 10 mg | DTG CL/F for Part 2 | 0.487 Liters/hour | Geometric Coefficient of Variation 18.8 |
| DTG 50 mg | DTG CL/F for Part 2 | 0.513 Liters/hour | Geometric Coefficient of Variation 26.9 |
| DTG 25 mg (Reference) | DTG CL/F for Part 2 | 0.792 Liters/hour | Geometric Coefficient of Variation 34.4 |
Secondary
Lambda Z of DTG for Part 2
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 10 mg | Lambda Z of DTG for Part 2 | 0.0443 per hour | Geometric Coefficient of Variation 15.3 |
| DTG 50 mg | Lambda Z of DTG for Part 2 | 0.0448 per hour | Geometric Coefficient of Variation 14.3 |
| DTG 25 mg (Reference) | Lambda Z of DTG for Part 2 | 0.0439 per hour | Geometric Coefficient of Variation 14.7 |
Secondary
Last Observed Quantifiable Concentration (Ct) of DTG for Part 1
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 10 mg | Last Observed Quantifiable Concentration (Ct) of DTG for Part 1 | 106 ng/mL | Geometric Coefficient of Variation 72.8 |
| DTG 50 mg | Last Observed Quantifiable Concentration (Ct) of DTG for Part 1 | 114 ng/mL | Geometric Coefficient of Variation 73.5 |
Secondary
Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1
Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood and urine protein. In this dipstick test, the level of ketones, glucose, occult blood and protein in urine samples was recorded as negative trace, 1+, 2+, and 3+ (the plus sign increases with a higher level of glucose, ketones, or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive). Urine samples were collected for the measurement of urinalysis parameters by dipstick method up-to follow-up (Day 25) in Part 1. Only categories with significant values have been presented.
Time frame: Up to 25 days in Part 1
Population: All Subjects Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTG 10 mg | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine Occult Blood,Trace,Day 2 (-24 hours) | 0 Participants |
| DTG 10 mg | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine Occult Blood, 2+, Day 2 (-24 hours) | 0 Participants |
| DTG 10 mg | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine Ketones, Trace, Follow-up | 0 Participants |
| DTG 10 mg | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine Occult Blood, 3+, Day 2 (-24 hours) | 1 Participants |
| DTG 10 mg | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine Occult Blood, 1+, Day 2 (-24 hours) | 1 Participants |
| DTG 10 mg | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine Protein, 3+, Day 2 (-24 hours) | 1 Participants |
| DTG 10 mg | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine Ketones, Trace, Day 2 (-24 hours) | 2 Participants |
| DTG 50 mg | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine Protein, 3+, Day 2 (-24 hours) | 0 Participants |
| DTG 50 mg | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine Ketones, Trace, Day 2 (-24 hours) | 2 Participants |
| DTG 50 mg | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine Ketones, Trace, Follow-up | 1 Participants |
| DTG 50 mg | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine Occult Blood,Trace,Day 2 (-24 hours) | 1 Participants |
| DTG 50 mg | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine Occult Blood, 1+, Day 2 (-24 hours) | 0 Participants |
| DTG 50 mg | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine Occult Blood, 2+, Day 2 (-24 hours) | 1 Participants |
| DTG 50 mg | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine Occult Blood, 3+, Day 2 (-24 hours) | 0 Participants |
Secondary
Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2
Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood and urine protein. In this dipstick test, the level of ketones, glucose, occult blood and protein in urine samples was recorded as negative trace, 1+, 2+, and 3+ (the plus sign increases with a higher level of glucose, ketones, or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive). Urine samples were collected for the measurement of urinalysis parameters by dipstick method up-to follow-up (Day 36) in Part 2. Only categories with significant values have been presented.
Time frame: Up to 36 days in Part 2
Population: All Subjects Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTG 10 mg | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2 | Urine Ketones, Trace, Day 2 (-24 hours) | 1 Participants |
| DTG 10 mg | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2 | Urine Occult Blood,1+ Follow-up, | 1 Participants |
| DTG 10 mg | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2 | Urine Occult Blood, 3+, Day 2 (-24 hours) | 1 Participants |
| DTG 10 mg | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2 | Urine Protein, 1+, Day 2 (-24 hours) | 1 Participants |
| DTG 10 mg | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2 | Urine Occult Blood,Trace,Day 2 (-24 hours) | 1 Participants |
| DTG 50 mg | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2 | Urine Protein, 1+, Day 2 (-24 hours) | 0 Participants |
| DTG 50 mg | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2 | Urine Ketones, Trace, Day 2 (-24 hours) | 0 Participants |
| DTG 50 mg | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2 | Urine Occult Blood,Trace,Day 2 (-24 hours) | 1 Participants |
| DTG 50 mg | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2 | Urine Occult Blood, 3+, Day 2 (-24 hours) | 1 Participants |
| DTG 50 mg | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2 | Urine Occult Blood,1+ Follow-up, | 0 Participants |
| DTG 25 mg (Reference) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2 | Urine Occult Blood,Trace,Day 2 (-24 hours) | 0 Participants |
| DTG 25 mg (Reference) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2 | Urine Protein, 1+, Day 2 (-24 hours) | 0 Participants |
| DTG 25 mg (Reference) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2 | Urine Occult Blood,1+ Follow-up, | 0 Participants |
| DTG 25 mg (Reference) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2 | Urine Ketones, Trace, Day 2 (-24 hours) | 0 Participants |
| DTG 25 mg (Reference) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2 | Urine Occult Blood, 3+, Day 2 (-24 hours) | 0 Participants |
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) for Part 1
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Data has been presented for AEs and SAEs up-to follow-up (25 days) in Part 1. All Subjects Population was defined as all participants who received at least 1 dose of study medication.
Time frame: Up to 25 days in Part 1
Population: All Subjects Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTG 10 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) for Part 1 | Any AE | 1 Participants |
| DTG 10 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) for Part 1 | Any SAE | 0 Participants |
| DTG 50 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) for Part 1 | Any AE | 2 Participants |
| DTG 50 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) for Part 1 | Any SAE | 0 Participants |
Secondary
Number of Participants With Adverse Events AEs and Serious Adverse Events SAEs for Part 2
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Data has been presented for AEs and SAEs up-to follow-up (36 days) in Part 2.
Time frame: Up to 36 days in Part 2
Population: All Subjects Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTG 10 mg | Number of Participants With Adverse Events AEs and Serious Adverse Events SAEs for Part 2 | Any AE | 2 Participants |
| DTG 10 mg | Number of Participants With Adverse Events AEs and Serious Adverse Events SAEs for Part 2 | Any SAE | 0 Participants |
| DTG 50 mg | Number of Participants With Adverse Events AEs and Serious Adverse Events SAEs for Part 2 | Any AE | 2 Participants |
| DTG 50 mg | Number of Participants With Adverse Events AEs and Serious Adverse Events SAEs for Part 2 | Any SAE | 0 Participants |
| DTG 25 mg (Reference) | Number of Participants With Adverse Events AEs and Serious Adverse Events SAEs for Part 2 | Any AE | 3 Participants |
| DTG 25 mg (Reference) | Number of Participants With Adverse Events AEs and Serious Adverse Events SAEs for Part 2 | Any SAE | 0 Participants |
Secondary
Number of Participants With Chemistry Toxicities of Grade 2 as Defined by Division of Acquired Immunodeficiency Syndrome (DAIDS) for Part 1
The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life threatening. low LDL (low-density lipid); HDL (high-density lipid). Data has been presented for clinical chemistry laboratory result parameter (serum sodium) with toxicity of Grade 2 for Part 1.
Time frame: Up to 25 days in Part 1
Population: All Subjects Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DTG 10 mg | Number of Participants With Chemistry Toxicities of Grade 2 as Defined by Division of Acquired Immunodeficiency Syndrome (DAIDS) for Part 1 | 1 Participants |
| DTG 50 mg | Number of Participants With Chemistry Toxicities of Grade 2 as Defined by Division of Acquired Immunodeficiency Syndrome (DAIDS) for Part 1 | 0 Participants |
Secondary
Number of Participants With Urinalysis Toxicities of Grade 2 as Defined by DAIDS for Part 1
The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life threatening, low LDL and HDL Data has been presented for urinalysis laboratory result parameter (urine protein by dipstick analysis) with toxicity of Grade 2 for Part 1.
Time frame: Up to 25 days in Part 1
Population: All Subjects Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DTG 10 mg | Number of Participants With Urinalysis Toxicities of Grade 2 as Defined by DAIDS for Part 1 | 1 Participants |
| DTG 50 mg | Number of Participants With Urinalysis Toxicities of Grade 2 as Defined by DAIDS for Part 1 | 0 Participants |
Secondary
Observed Concentration at 24 Hours After Dose Administration (C24) of DTG for Part 1
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 10 mg | Observed Concentration at 24 Hours After Dose Administration (C24) of DTG for Part 1 | 912 ng/mL | Geometric Coefficient of Variation 37.2 |
| DTG 50 mg | Observed Concentration at 24 Hours After Dose Administration (C24) of DTG for Part 1 | 916 ng/mL | Geometric Coefficient of Variation 29.4 |
Secondary
Percentage of AUC (0-infinity) Obtained by Extrapolation (%AUCex) of DTG for Part 1
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1
Population: PK Population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DTG 10 mg | Percentage of AUC (0-infinity) Obtained by Extrapolation (%AUCex) of DTG for Part 1 | 5.17 Percentage of AUC |
| DTG 50 mg | Percentage of AUC (0-infinity) Obtained by Extrapolation (%AUCex) of DTG for Part 1 | 5.52 Percentage of AUC |
Secondary
Plasma DTG Lag Time Before Observation of Drug Concentrations (Tlag) for Part 1
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1
Population: PK Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DTG 10 mg | Plasma DTG Lag Time Before Observation of Drug Concentrations (Tlag) for Part 1 | 0.00 hours |
| DTG 50 mg | Plasma DTG Lag Time Before Observation of Drug Concentrations (Tlag) for Part 1 | 0.00 hours |
Secondary
Plasma DTG Tlag for Part 2
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2
Population: PK Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DTG 10 mg | Plasma DTG Tlag for Part 2 | 0.00 hours |
| DTG 50 mg | Plasma DTG Tlag for Part 2 | 0.00 hours |
| DTG 25 mg (Reference) | Plasma DTG Tlag for Part 2 | 0.00 hours |
Secondary
t1/2 of DTG for Part 2
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 10 mg | t1/2 of DTG for Part 2 | 15.66 hours | Geometric Coefficient of Variation 15.3 |
| DTG 50 mg | t1/2 of DTG for Part 2 | 15.48 hours | Geometric Coefficient of Variation 14.3 |
| DTG 25 mg (Reference) | t1/2 of DTG for Part 2 | 15.78 hours | Geometric Coefficient of Variation 14.7 |
Secondary
Terminal Phase Half-life (t1/2) of DTG for Part 1
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1
Population: PK population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 10 mg | Terminal Phase Half-life (t1/2) of DTG for Part 1 | 15.81 hours | Geometric Coefficient of Variation 22.7 |
| DTG 50 mg | Terminal Phase Half-life (t1/2) of DTG for Part 1 | 16.23 hours | Geometric Coefficient of Variation 20.8 |
Secondary
Terminal-phase Rate Constant (Lambda z) of DTG for Part 1
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 10 mg | Terminal-phase Rate Constant (Lambda z) of DTG for Part 1 | 0.0439 per hour | Geometric Coefficient of Variation 22.7 |
| DTG 50 mg | Terminal-phase Rate Constant (Lambda z) of DTG for Part 1 | 0.0427 per hour | Geometric Coefficient of Variation 20.8 |
Secondary
Time to First Occurrence of Cmax (Tmax) of DTG for Part 1
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1
Population: PK Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DTG 10 mg | Time to First Occurrence of Cmax (Tmax) of DTG for Part 1 | 2.01 hours |
| DTG 50 mg | Time to First Occurrence of Cmax (Tmax) of DTG for Part 1 | 2.00 hours |
Secondary
Tmax of DTG for Part 2
Blood sample were collected at the indicated time points after administration of study treatment to investigate the pharmacokinetic profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2
Population: PK Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DTG 10 mg | Tmax of DTG for Part 2 | 1.00 hours |
| DTG 50 mg | Tmax of DTG for Part 2 | 1.00 hours |
| DTG 25 mg (Reference) | Tmax of DTG for Part 2 | 1.75 hours |
Secondary
Urine pH Analysis by Dipstick Method for Part 2
Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Urine samples were collected for the measurement of urine pH by dipstick method up-to follow-up (Day 36) in Part 2. Only categories with significant values have been presented. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles).
Time frame: Up to 36 days in Part 2
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 10 mg | Urine pH Analysis by Dipstick Method for Part 2 | Urine pH, Day 2 (-24 hours), n=24, 24, 24 | 6.31 Points on a scale | Standard Deviation 0.586 |
| DTG 10 mg | Urine pH Analysis by Dipstick Method for Part 2 | Urine pH, Follow-up, n=3, 2, 3 | 5.33 Points on a scale | Standard Deviation 0.289 |
| DTG 50 mg | Urine pH Analysis by Dipstick Method for Part 2 | Urine pH, Day 2 (-24 hours), n=24, 24, 24 | 6.21 Points on a scale | Standard Deviation 0.641 |
| DTG 50 mg | Urine pH Analysis by Dipstick Method for Part 2 | Urine pH, Follow-up, n=3, 2, 3 | 5.50 Points on a scale | Standard Deviation 0 |
| DTG 25 mg (Reference) | Urine pH Analysis by Dipstick Method for Part 2 | Urine pH, Day 2 (-24 hours), n=24, 24, 24 | 6.31 Points on a scale | Standard Deviation 0.528 |
| DTG 25 mg (Reference) | Urine pH Analysis by Dipstick Method for Part 2 | Urine pH, Follow-up, n=3, 2, 3 | 6.83 Points on a scale | Standard Deviation 0.577 |
Secondary
Urine Potential of Hydrogen (pH) Analysis by Dipstick Method for Part 1
Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Urine samples were collected for the measurement of urine pH by dipstick method up-to follow-up (Day 25) in Part 1. Only categories with significant values have been presented. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles).
Time frame: Up to 25 days in Part 1
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 10 mg | Urine Potential of Hydrogen (pH) Analysis by Dipstick Method for Part 1 | Urine pH, Day 2 (-24 hours), n=14,14 | 6.43 Points on a scale | Standard Deviation 0.703 |
| DTG 10 mg | Urine Potential of Hydrogen (pH) Analysis by Dipstick Method for Part 1 | Urine pH, Follow-up, n=5,5 | 6.20 Points on a scale | Standard Deviation 0.57 |
| DTG 50 mg | Urine Potential of Hydrogen (pH) Analysis by Dipstick Method for Part 1 | Urine pH, Day 2 (-24 hours), n=14,14 | 6.25 Points on a scale | Standard Deviation 0.672 |
| DTG 50 mg | Urine Potential of Hydrogen (pH) Analysis by Dipstick Method for Part 1 | Urine pH, Follow-up, n=5,5 | 6.00 Points on a scale | Standard Deviation 0.612 |
Secondary
Urine Specific Gravity Analysis by Dipstick Method for Part 1
Urinary specific gravity measurement is a routine part of urinalysis. 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. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected for the measurement of urine specific gravity by dipstick method up-to follow-up (Day 25) in Part 1. Only categories with significant values have been presented. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles).
Time frame: Up to 25 days in Part 1
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 10 mg | Urine Specific Gravity Analysis by Dipstick Method for Part 1 | Urine Specific Gravity,Day 2(-24 hours),n=14,14 | 1.0131 Ratio | Standard Deviation 0.00871 |
| DTG 10 mg | Urine Specific Gravity Analysis by Dipstick Method for Part 1 | Urine Specific Gravity,Follow-up,n=5,5 | 1.0180 Ratio | Standard Deviation 0.00831 |
| DTG 50 mg | Urine Specific Gravity Analysis by Dipstick Method for Part 1 | Urine Specific Gravity,Day 2(-24 hours),n=14,14 | 1.0177 Ratio | Standard Deviation 0.00752 |
| DTG 50 mg | Urine Specific Gravity Analysis by Dipstick Method for Part 1 | Urine Specific Gravity,Follow-up,n=5,5 | 1.0150 Ratio | Standard Deviation 0.01093 |
Secondary
Urine Specific Gravity Analysis by Dipstick Method for Part 2
Urinary specific gravity measurement is a routine part of urinalysis. 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. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected for the measurement of urine specific gravity by dipstick method up-to follow-up (Day 36) in Part 2. Only categories with significant values have been presented. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time frame: Up to 36 days in Part 2
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 10 mg | Urine Specific Gravity Analysis by Dipstick Method for Part 2 | Urine Specific Gravity,Day 2(-24 hours),n=24,24,24 | 1.0143 Ratio | Standard Deviation 0.00636 |
| DTG 10 mg | Urine Specific Gravity Analysis by Dipstick Method for Part 2 | Urine Specific Gravity,Follow-up,n=3,2,3 | 1.0207 Ratio | Standard Deviation 0.00862 |
| DTG 50 mg | Urine Specific Gravity Analysis by Dipstick Method for Part 2 | Urine Specific Gravity,Day 2(-24 hours),n=24,24,24 | 1.0148 Ratio | Standard Deviation 0.00515 |
| DTG 50 mg | Urine Specific Gravity Analysis by Dipstick Method for Part 2 | Urine Specific Gravity,Follow-up,n=3,2,3 | 1.0165 Ratio | Standard Deviation 0.00354 |
| DTG 25 mg (Reference) | Urine Specific Gravity Analysis by Dipstick Method for Part 2 | Urine Specific Gravity,Day 2(-24 hours),n=24,24,24 | 1.0141 Ratio | Standard Deviation 0.00674 |
| DTG 25 mg (Reference) | Urine Specific Gravity Analysis by Dipstick Method for Part 2 | Urine Specific Gravity,Follow-up,n=3,2,3 | 1.0117 Ratio | Standard Deviation 0.00551 |
Secondary
Vz/F of DTG for Part 2
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DTG 10 mg | Vz/F of DTG for Part 2 | 11.0 Liters | Geometric Coefficient of Variation 15.8 |
| DTG 50 mg | Vz/F of DTG for Part 2 | 11.4 Liters | Geometric Coefficient of Variation 24.6 |
| DTG 25 mg (Reference) | Vz/F of DTG for Part 2 | 18.0 Liters | Geometric Coefficient of Variation 33.5 |