Effect of Dolutegravir on Metformin Pharmacokinetics in Healthy Adult Subjects
Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
Participant gender:
Summary
This study will be a phase 1, open label, parallel group, three period crossover study to
evaluate the effect of dolutegravir (DTG) on the steady state pharmacokinetics of metformin
and on the safety and tolerability of dolutegravir and metformin. Subjects will have a
screening visit within 30 days prior to the first dose of study drug, three treatment
periods, and a follow up visit 7-14 days after the last dose of study drug. Eligible subjects
will be assigned to one of the two treatment cohorts. Subjects will receive metformin 500
milligram (mg) after every 12 hours (q12h) for 5 days in Period 1; metformin 500 mg q12h plus
dolutegravir 50 mg after every 24 hours (q24h) (Cohort 1) or 50 mg q12h (Cohort 2) for 7 days
in Period 2; and metformin 500 mg q12h for 10 days in Period 3. There will be no washout
periods between treatments. All doses of study drug will be taken following a meal. Safety
evaluations will be collected during each period. Serial pharmacokinetic (PK) samples will be
collected for metformin on the last day of each period and for dolutegravir on the last day
of Period 2.