Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dolutegravir q24h · 1 trial · 1 indication
PK parameters will include: maximum concentration (Cmax), area under the time-concentration curve over the dosing interval \[AUC(0-tau)\]
PK parameters will include: Area under the time-concentration curve over the dosing interval \[AUC(0-tau)\], apparent clearance following oral dosing (CL/F), concentration at time zero (C0) and maximum concentration (Cmax)
PK parameters will include: Terminal phase half-life (t1/2) and Apparent clearance following oral dosing (CL/F)
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | All subjects will be assigned to a single-sequence of three treatment periods without washout. Subjects will receive Metformin immediate release (IR) 500 mg q12h following a moderate fat meal for 5 days (Period 1), followed by Metformin IR 500 mg q12h plus DTG 50 mg q24h following a moderate fat meal for 7 days (Days 1-7 of Period 2), followed by Metformin IR 500 mg q12h following a moderate fat meal (Days 1-10 of period 3). |
| Cohort 2 | EXPERIMENTAL | All subjects will be assigned to a single-sequence of three treatment periods without washout. Subjects will receive Metformin IR 500 mg q12h following a moderate fat meal (Day 1-5 of Period 1), followed by Metformin IR 500 mg q12h plus DTG 50 mg q12h following a moderate fat meal for 7 days (Days 1-7 of Period 2), followed by Metformin IR 500 mg q12h following a moderate fat meal (Days 1-10 of period 3). |
| Name | Type | Description |
|---|---|---|
| Metformin 500 mg q12h | DRUG | Metformin will be supplied as 500 mg tablet to be administered orally. |
| Dolutegravir 50 mg q24h | DRUG | Dolutegravir will be supplied as 50 mg tablet to be administered orally. To be taken once a day in the morning in Period 2 (Total daily dose 50 mg per day for Cohort 1 only) |
| Dolutegravir 50 mg q12h | DRUG | Dolutegravir will be supplied as 50 mg tablet to be administered orally. To be taken 50 mg tablets every 12 hours in Period 2 (Total daily dose 100 mg per day for Cohort 2 only). |
Inclusion Criteria: * Male/females aged between 18 and 65 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including \[medical history, physical examination, laboratory tests and ca...
Dolutegravir q24h is an investigational small molecule being developed for the treatment of Human Immunodeficiency Virus (HIV) infection. It is currently in Phase 1 clinical development. The drug is being studied for its effects in healthy volunteers as part of early-stage research.
Dolutegravir q24h is being developed by GSK plc, which trades under the ticker symbol GSK. The company is conducting clinical research on this small molecule drug candidate for the treatment of HIV infection.
Dolutegravir q24h is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in early-stage trials to evaluate its pharmacokinetics and safety profile.
Dolutegravir q24h has one completed clinical trial, NCT02064374, titled "Effect of Dolutegravir on Metformin Pharmacokinetics in Healthy Adult Subjects." This Phase 1 study enrolled 30 participants in the United States and was a controlled trial involving healthy volunteers.
Dolutegravir q24h is a formulation of dolutegravir dosed once every 24 hours. The clinical trial NCT02064374 studied the effect of dolutegravir on metformin pharmacokinetics in healthy subjects, indicating that the active ingredient is dolutegravir.