Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Conventional dolutegravir · 1 trial · 1 indication
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.
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..
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.
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..
| Arm | Type | Description |
|---|---|---|
| Treatment sequence A/B: Part 1 | EXPERIMENTAL | Eligible subjects will be randomized in sequence A/B in Part 1 and will receive A: conventional 10 mg DTG tablet (5 tablets) in Period 1 and B: conventional 50 mg DTG tablet in Period 2, administered directly to mouth. |
| Treatment sequence B/A: Part 1 | EXPERIMENTAL | Eligible subjects will be randomized in sequence B/A in Part 1 and will receive B: conventional 50 mg DTG tablet in Period 1 and A: conventional 10 mg DTG tablet (5 tablets) in Period 2, administered directly to mouth. |
| Treatment sequence C/D/E: Part 2 | EXPERIMENTAL | Eligible subjects will be randomized in sequence C/D/E in Part 2 and will receive C: 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken in Period 1, D: 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth in Period 2 and E: conventional 25 mg DTG tablet administered as direct to mouth in Period 3. |
| Treatment sequence D/E/C: Part 2 | EXPERIMENTAL | Eligible subjects will be randomized in sequence D/E/C in Part 2 and will receive D: 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth in Period 1, E: conventional 25 mg DTG tablet administered as direct to mouth in Period 2 and C: 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken in Period 3. |
| Treatment sequence E/C/D: Part 2 | EXPERIMENTAL | Eligible subjects will be randomized in sequence E/C/D in Part 2 and will receive E: conventional 25 mg DTG tablet administered as direct to mouth in Period 1, C: 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken in Period 2 and D: 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth in Period 3. |
| Treatment sequence C/E/D: Part 2 | EXPERIMENTAL | Eligible subjects will be randomized in sequence C/E/D in Part 2 and will receive C: 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken in Period 1, E: conventional 25 mg DTG tablet administered as direct to mouth in Period 2 and D: 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth in Period 3. |
| Treatment sequence D/C/E: Part 2 | EXPERIMENTAL | Eligible subjects will be randomized in sequence D/C/E in Part 2 and will receive D: 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth in Period 1, C: 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken in Period 2 and E: conventional 25 mg DTG tablet administered as direct to mouth in Period 3. |
| Treatment sequence E/D/C: Part 2 | EXPERIMENTAL | Eligible subjects will be randomized in sequence E/D/C in Part 2 and will receive E: conventional 25 mg DTG tablet administered as direct to mouth in Period 1, D: 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth in Period 2 and C: 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken in Period 3. |
| Name | Type | Description |
|---|---|---|
| Conventional dolutegravir 10 mg tablet | DRUG | 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. |
| Conventional dolutegravir 50 mg tablet | DRUG | 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. |
| Dispersible dolutegravir 5 mg tablet | DRUG | 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. |
| Conventional dolutegravir 25 mg tablet | DRUG | 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. |
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 evalua...
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Conventional dolutegravir is an investigational small molecule being studied for the treatment of HIV Infections. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities. The drug is being evaluated in clinical trials to assess its safety and pharmacokinetics in this patient population.
Conventional dolutegravir is being developed by GSK plc, a global biopharmaceutical company. GSK's stock is traded under the ticker symbol GSK. The company is conducting clinical trials to evaluate the drug's safety and bioavailability in healthy volunteers and individuals with HIV Infections.
Conventional dolutegravir is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied in a completed Phase 1 trial to evaluate its bioavailability and pharmacokinetic profile.
Conventional dolutegravir has one completed clinical trial, NCT03095638, titled 'Bioavailability Study of 10 Milligram (mg) and 5 mg Tablets Versus Conventional Tablets of Dolutegravir.' This Phase 1 study enrolled 38 participants in the United States, including healthy volunteers, and was a controlled, randomized trial.
Conventional dolutegravir is a formulation of the drug dolutegravir, an integrase inhibitor used in HIV treatment. The clinical trial NCT03095638 compares 10 mg and 5 mg tablets of dolutegravir against conventional tablets of dolutegravir to assess their bioavailability. The drug is being developed by GSK plc.