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NCT01230385 · ClinicalTrials.gov registry record · Phase 1
Safety And Tolerability Of Multiple Dose Lersivirine For 21 Days In Healthy Subjects
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
NCT01230385: Completed Phase 1 study, sponsored by Pfizer.
NCT01230385 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 75 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01230385, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
Study Summary
Randomized, open-label, parallel group study in a group of 75 healthy subjects, to evaluate the safety and toleration of 2 different doses of lersivirine administered either fed or fasted (proposed Phase 3 formulation) given over 21 days, compared to lersivirine 500 mg QD (Phase 2b formulation). The pharmacokinetics of lersivirine in each group will also be evaluated.
Interventions
- DRUG Lersivirine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2010-10 |
| Est. Completion | 2011-05 |
| Phase | Phase 1 |
What the finished NCT01230385 record still lists
NCT01230385 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher).
The record links to 0 conditions, and to 1 intervention - of which Lersivirine is the first listed.
NCT01230385 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01230385 about?
NCT01230385 is a clinical study titled "Safety And Tolerability Of Multiple Dose Lersivirine For 21 Days In Healthy Subjects". Randomized, open-label, parallel group study in a group of 75 healthy subjects, to evaluate the safety and toleration of 2 different doses of lersivirine administered either fed or fasted (proposed Phase 3 formulation) given over 21 days, compared to lersivirine 500 mg QD (Phase 2b formulation). The...
What is the current status of trial NCT01230385?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2010-10. Estimated completion is 2011-05.
What interventions are being tested in trial NCT01230385?
The interventions under investigation include: Lersivirine (DRUG).
Who is sponsoring clinical trial NCT01230385?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01230385's enrollment target sits among peer trials
75 711th of 2000 higher than 1,276 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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