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NCT01967771 · ClinicalTrials.gov registry record · Phase 1
Effect of Carbamazepine on Dolutegravir Pharmacokinetics in Healthy Adult Subjects
A Phase 1 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT01967771: Completed Phase 1 study, sponsored by ViiV Healthcare.
NCT01967771 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01967771, a Phase 1 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This study will be a phase I, open label, three period, fixed sequence crossover study to evaluate the effect of Carbamazepine (CBZ) on the steady-state pharmacokinetics of Dolutegravir (DTG) and on the safety and tolerability of DTG. 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. There is no washout between treatment periods.
Primary Outcome
PK parameters will include: Steady state plasma DTG concentration at the end of the dosing interval (Ctau), maximum concentration (Cmax), area under the time-concentration curve over the dosing interval \[AUC(0-tau)\], apparent clearance following oral dosing (CL/F), terminal phase half life (t1/2), concentration at time zero (C0) and minimum concentration (Cmin)
Interventions
- DRUG DTG
- DRUG CBZ
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2013-10 |
| Est. Completion | 2014-01 |
| Phase | Phase 1 |
What the finished NCT01967771 record still lists
NCT01967771 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which DTG is the first listed.
NCT01967771 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01967771 about?
NCT01967771 is a clinical study titled "Effect of Carbamazepine on Dolutegravir Pharmacokinetics in Healthy Adult Subjects". This study will be a phase I, open label, three period, fixed sequence crossover study to evaluate the effect of Carbamazepine (CBZ) on the steady-state pharmacokinetics of Dolutegravir (DTG) and on the safety and tolerability of DTG. Subjects will have a screening visit within 30 days prior to the ...
What is the current status of trial NCT01967771?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2013-10. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01967771?
The interventions under investigation include: DTG (DRUG), CBZ (DRUG).
Who is sponsoring clinical trial NCT01967771?
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 NCT01967771's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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