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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 is a Phase 1 study of Clinical Pharmacology, Healthy Volunteer Study that has completed, run by Celgene. The registered enrollment target is 72 participants. The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01986894
The ClinicalTrials.gov registry entry for NCT01986894 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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