Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Metformin q12h · 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...
Metformin q12h is a dosing regimen of metformin, a small molecule drug, given every 12 hours. It is being studied by GSK plc in the infectious disease area, specifically for HIV infection. The regimen is also known as Metformin 500 mg q12h.
Metformin q12h is being investigated for use in HIV infection. It is not yet approved for this indication and remains in clinical development. The only listed trial evaluated its use in healthy adult subjects, not as a direct treatment for HIV.
Metformin q12h targets mitochondrial complex I subunits, specifically MT-ND6, NDUFA10, NDUFS8, MT-ND4L, NDUFA6, and MT-ND1. It acts as an inhibitor of these targets. This mechanism is distinct from its traditional role in diabetes.
Metformin q12h is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical trial evaluating this dosing regimen.
Metformin q12h is in Phase 1 clinical development. It is investigational and has not been approved by the FDA for any indication. The single Phase 1 trial has been completed.
Metformin q12h has been studied in one completed Phase 1 trial, NCT02064374, titled "Effect of Dolutegravir on Metformin Pharmacokinetics in Healthy Adult Subjects." The trial enrolled 30 healthy volunteers in the United States and was controlled but not randomized or double blinded.