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NCT01986894 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 QT Study in Healthy Male Subjects
A Phase 1 study of Clinical Pharmacology, Healthy Volunteer Study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT01986894: Completed Phase 1 study of Clinical Pharmacology, Healthy Volunteer Study, sponsored by Celgene.
NCT01986894 is a Phase 1 study of Clinical Pharmacology, Healthy Volunteer Study that has completed, run by Celgene. The registered enrollment target is 72 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01986894, a Phase 1 study of Clinical Pharmacology, Healthy Volunteer Study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-center, randomized, double-blind crossover study with four treatments, four periods and four sequences to investigate the effects of orally administered pomalidomide on QT interval. The study will be conducted in healthy male subjects. Pomalidomide (clinically indicated dose for multiple myeloma \[MM\] as per the United States Package Insert \[USPI\] of 4 mg and supratherapeutic dose of 20 mg) and placebo treatments will be double-blinded. Moxifloxacin (positive control) will be administered in an open-label fashion to determine the sensitivity of the assay. The core electrocardiogram (ECG) laboratory and ECG readers will be blinded to all study treatments and sequences.
Primary Outcome
To evaluate the effect of pomalidomide on the time matched changes from placebo in the baseline adjusted QT interval of the electrocardiogram (ECG) using the Fridericia correction method (QTcF)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Pomalidomide
- DRUG Moxifloxacin
Study Locations (1)
Texas
- PPD Phase I Clinic - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2013-10-18 |
| Est. Completion | 2013-12-02 |
| Phase | Phase 1 |
What the finished NCT01986894 record still lists
NCT01986894 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher).
The record links to 1 condition, with Clinical Pharmacology, Healthy Volunteer Study appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01986894 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01986894 about?
NCT01986894 is a clinical study titled "A Phase 1 QT Study in Healthy Male Subjects". This is a single-center, randomized, double-blind crossover study with four treatments, four periods and four sequences to investigate the effects of orally administered pomalidomide on QT interval. The study will be conducted in healthy male subjects. Pomalidomide (clinically indicated dose for mul...
What is the current status of trial NCT01986894?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2013-10-18. Estimated completion is 2013-12-02.
What conditions does trial NCT01986894 study?
This clinical trial studies the following conditions: Clinical Pharmacology, Healthy Volunteer Study.
What interventions are being tested in trial NCT01986894?
The interventions under investigation include: Placebo (DRUG), Pomalidomide (DRUG), Moxifloxacin (DRUG).
Who is sponsoring clinical trial NCT01986894?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01986894 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01986894's enrollment target sits among peer trials
72 736th of 2000 higher than 1,254 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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