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NCT01695954 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Study of Pitavastatin and Ritonavir-Boosted Darunavir or Efavirenz
A Phase 1 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT01695954: Completed Phase 1 study, sponsored by NYU Langone Health.
NCT01695954 is a Phase 1 study that has completed, run by NYU Langone Health. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01695954, a Phase 1 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
The main goal of this study is to determine how taking efavirenz affects the levels of pitavastatin in the bloodstream when both drugs are taken together and to see how darunavir with ritonavir affects the levels of pitavastatin in the bloodstream. Secondary goals are to see how taking pitavastatin affects the levels in the blood of efavirenz when both drugs are taken together and to see how taking pitavastatin affects the levels in the blood of darunavir.
Primary Outcome
24-hour area under the curve (AUC) for pitavastatin when coadministered with efavirenz and with darunavir/ritonavir and 24-hour AUC for efavirenz or darunavir when coadministered with pitavastatin
Interventions
- DRUG Ritonavir
- DRUG Efavirenz
- DRUG Darunavir
- DRUG Pitavastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2012-05 |
| Est. Completion | 2013-01 |
| Phase | Phase 1 |
What the finished NCT01695954 record still lists
NCT01695954 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 4 interventions - of which Ritonavir is the first listed.
NCT01695954 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01695954 about?
NCT01695954 is a clinical study titled "Pharmacokinetic Study of Pitavastatin and Ritonavir-Boosted Darunavir or Efavirenz". The main goal of this study is to determine how taking efavirenz affects the levels of pitavastatin in the bloodstream when both drugs are taken together and to see how darunavir with ritonavir affects the levels of pitavastatin in the bloodstream. Secondary goals are to see how taking pitavastatin ...
What is the current status of trial NCT01695954?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2012-05. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01695954?
The interventions under investigation include: Ritonavir (DRUG), Efavirenz (DRUG), Darunavir (DRUG), Pitavastatin (DRUG).
Who is sponsoring clinical trial NCT01695954?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01695954's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 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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