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NCT02064374 · ClinicalTrials.gov registry record · Phase 1
Effect of Dolutegravir on Metformin Pharmacokinetics in Healthy Adult Subjects
A Phase 1 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT02064374: Completed Phase 1 study, sponsored by ViiV Healthcare.
NCT02064374 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02064374, a Phase 1 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study 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.
Primary Outcome
PK parameters will include: maximum concentration (Cmax), area under the time-concentration curve over the dosing interval \[AUC(0-tau)\]
Interventions
- DRUG Metformin 500 mg q12h
- DRUG Dolutegravir 50 mg q24h
- DRUG Dolutegravir 50 mg q12h
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2014-02 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
What the finished NCT02064374 record still lists
NCT02064374 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 3 interventions - of which Metformin 500 mg q12h is the first listed.
NCT02064374 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02064374 about?
NCT02064374 is a clinical study titled "Effect of Dolutegravir on Metformin Pharmacokinetics in Healthy Adult Subjects". 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 ...
What is the current status of trial NCT02064374?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2014-02. Estimated completion is 2014-05.
What interventions are being tested in trial NCT02064374?
The interventions under investigation include: Metformin 500 mg q12h (DRUG), Dolutegravir 50 mg q24h (DRUG), Dolutegravir 50 mg q12h (DRUG).
Who is sponsoring clinical trial NCT02064374?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02064374's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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