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 a small molecule drug candidate being developed by GSK plc for HIV Infections. It is in Phase 1 clinical development. The asset is also known as conventional dolutegravir 10 mg tablet. It has been studied in a single completed Phase 1 bioavailability trial.
Conventional dolutegravir is being developed for the treatment of HIV Infections. It is an investigational small molecule in Phase 1 development, and its only recorded clinical trial enrolled healthy adult volunteers rather than patients with HIV. No approved indication has been established for this asset.
Conventional dolutegravir is developed by GSK plc, which trades under the ticker GSK. The company is the sponsor of the Phase 1 bioavailability study of the 10 mg and 5 mg tablets versus conventional dolutegravir tablets.
Conventional dolutegravir is in Phase 1 clinical development. Its single recorded trial, NCT03095638, is a completed Phase 1 bioavailability study. The drug is investigational and has not been approved for any indication based on the available development record.
Conventional dolutegravir has been studied in one clinical trial, NCT03095638, titled Bioavailability Study of 10 Milligram (mg) and 5 mg Tablets Versus Conventional Tablets of Dolutegravir. The Phase 1 trial was completed, enrolled 38 healthy adult volunteers in the United States, and used a randomized, controlled design.