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NCT01827540 · ClinicalTrials.gov registry record · Phase 1
Study of Dolutegravir (DTG) on PK of Cenicriviroc (CVC), and CVC on PK of DTG & on a Single Dose of Midazolam
A Phase 1 study, sponsored by Tobira Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01827540: Completed Phase 1 study, sponsored by Tobira Therapeutics.
NCT01827540 is a Phase 1 study that has completed, run by Tobira Therapeutics. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01827540, a Phase 1 study, has completed, sponsored by Tobira Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
To evaluate the PK, safety and tolerability of Cenicriviroc (CVC) administered with and without Dolutegravir (DTG) and CVC with and without a single dose of Midazolam in healthy subjects.
Primary Outcome
PK profile will be calculated based on CVC exposure. Trough (predose) CVC plasma samples will be obtained prior to dosing on Days 2-9 \& 12-19.
Interventions
- DRUG Midazolam
- DRUG Dolutegravir
- DRUG Cenicriviroc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-03 |
| Est. Completion | 2013-05 |
| Phase | Phase 1 |
What the finished NCT01827540 record still lists
NCT01827540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 3 interventions - of which Midazolam is the first listed.
NCT01827540 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01827540 about?
NCT01827540 is a clinical study titled "Study of Dolutegravir (DTG) on PK of Cenicriviroc (CVC), and CVC on PK of DTG & on a Single Dose of Midazolam". To evaluate the PK, safety and tolerability of Cenicriviroc (CVC) administered with and without Dolutegravir (DTG) and CVC with and without a single dose of Midazolam in healthy subjects.
What is the current status of trial NCT01827540?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2013-03. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01827540?
The interventions under investigation include: Midazolam (DRUG), Dolutegravir (DRUG), Cenicriviroc (DRUG).
Who is sponsoring clinical trial NCT01827540?
This trial is sponsored by Tobira Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01827540's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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