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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 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 30 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02064374
The ClinicalTrials.gov registry entry for NCT02064374 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Metformin 500 mg q12h is the first listed.
NCT02064374 reports 0 study locations.
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.
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