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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 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 75 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01230385
The ClinicalTrials.gov registry entry for NCT01230385 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Lersivirine is the first listed.
NCT01230385 reports 0 study locations.
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.
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