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NCT01707407 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Open-Label Study to Evaluate the Effect of CYP450 and P-gp Inhibition and Induction on the Pharmacokinetics of Pomalidomide (CC-4047) in Healthy Male Subjects
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT01707407 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 32 participants.
The verdict
NCT01707407, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
1. To evaluate the pharmacokinetics (PK) of pomalidomide administered with the CYP3A4/P-gp inhibitor ketoconazole compared with pomalidomide alone in healthy male subjects. 2. To evaluate the PK of pomalidomide administered with the CYP3A4/P-gp inhibitor ketoconazole plus the CYP1A2 inhibitor fluvoxamine compared with pomalidomide alone in healthy male subjects. 3. To assess the PK of pomalidomide administered with the CYP1A2 inhibitor fluvoxamine and the CYP3A4/P-gp inhibitor ketoconazole compared with pomalidomide plus the CYP3A4/P-gp inhibitor ketoconazole in healthy male subjects. Part 2 1\) To evaluate the pharmacokinetics of pomalidomide administered with the CYP3A4 inducer carbamazepine compared with pomalidomide alone in healthy male volunteers. Secondary Objectives 1\) To evaluate the safety of pomalidomide in Part 1 and Part 2 when administered with ketoconazole, fluvoxamine and/or carbamazepine. In addition: To evaluate the safety of pomalidomide in Part 1 and Part 2 when administered with ketoconazole, fluvoxamine and/or carbamazepine.
Interventions
- DRUG Pomalidomide
- DRUG Fluvoxamine
- DRUG Carbamazepine
- DRUG Ketoconazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2012-09-01 |
| Est. Completion | 2012-11-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01707407
The ClinicalTrials.gov registry entry for NCT01707407 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 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 0 conditions, and to 4 interventions - of which Pomalidomide is the first listed.
NCT01707407 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01707407 about?
NCT01707407 is a clinical study titled "A Phase 1 Open-Label Study to Evaluate the Effect of CYP450 and P-gp Inhibition and Induction on the Pharmacokinetics of Pomalidomide (CC-4047) in Healthy Male Subjects". 1. To evaluate the pharmacokinetics (PK) of pomalidomide administered with the CYP3A4/P-gp inhibitor ketoconazole compared with pomalidomide alone in healthy male subjects. 2. To evaluate the PK of pomalidomide administered with the CYP3A4/P-gp inhibitor ketoconazole plus the CYP1A2 inhibitor fluvox...
What is the current status of trial NCT01707407?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2012-09-01. Estimated completion is 2012-11-01.
What interventions are being tested in trial NCT01707407?
The interventions under investigation include: Pomalidomide (DRUG), Fluvoxamine (DRUG), Carbamazepine (DRUG), Ketoconazole (DRUG).
Who is sponsoring clinical trial NCT01707407?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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