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A Phase 1 QT Study in Healthy Male Subjects
NCT01986894 · View on ClinicalTrials.gov ↗
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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 73 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01986894 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01986894?
The interventions under investigation include: Placebo (DRUG), Pomalidomide (DRUG), Moxifloxacin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01986894?
This trial is sponsored by Celgene, which has 73 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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