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NCT03624959 · ClinicalTrials.gov registry record · Phase 1
Drug-drug Interaction Study of Ozanimod With Inhibitor or Inducer of CYP2C8 and/or CYP3A
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
NCT03624959 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 100 participants.
The verdict
NCT03624959, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effect of the following index inhibitors or inducers of CYP2C8 and/or CYP3A on the single-dose pharmacokinetics (PK) of ozanimod and its major active metabolite, CC112273, in healthy adult subjects: gemfibrozil (strong inhibitor of CYP2C8), rifampin (moderate inducer of CYP2C8 and strong inducer of CYP3A), and itraconazole (strong inhibitor of CYP3A). Study Design This is a Phase 1, randomized, parallel-group, open-label study with two parts, 1 and 2. Forty subjects will be enrolled in Part 1 and will be randomized into 1 of the 2 treatment groups, with 20 subjects in each treatment group. Sixty subjects will be enrolled in Part 2 and will be randomized into 1 of the 3 treatment groups, with 20 subjects in each treatment group. . Study parts and treatment groups are as follow: Part 1: * Treatment Group A (reference): A single dose of ozanimod. * Treatment Group B (test): Gemfibrozil 600 mg twice daily (BID) on Days 1 through 17. On Day 4, a single dose of ozanimod will be coadministered with the morning dose of gemfibrozil. Part 2: * Treatment Group C (reference): A single dose of ozanimod. * Treatment Group D (test): Itraconazole 200 mg once daily (QD) on Days 1 through 17. On Day 4, a single dose of ozanimod will be coadministered with itraconazole. * Treatment Group E (test): Rifampin 600 mg QD on Days 1 through 21. On Day 8, a single dose of ozanimod will be coadministered with rifampin. Study Population Subjects will be healthy men and non-pregnant, non-lactating women, ages 18 to 55 years, inclusive, with a body weight of at least 110 pounds (50 kg); body mass index (BMI) within the range of 18.0 to 30.0 kg/m2, inclusive. Length of Study The study duration ranges from 43 days to 50 days.
Interventions
- DRUG Rifampin
- DRUG Itraconazole
- DRUG Ozanimod
- DRUG Gemfibrozil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2018-06-20 |
| Est. Completion | 2018-08-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03624959
The ClinicalTrials.gov registry entry for NCT03624959 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 100 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 Rifampin is the first listed.
NCT03624959 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03624959 about?
NCT03624959 is a clinical study titled "Drug-drug Interaction Study of Ozanimod With Inhibitor or Inducer of CYP2C8 and/or CYP3A". The purpose of this study is to evaluate the effect of the following index inhibitors or inducers of CYP2C8 and/or CYP3A on the single-dose pharmacokinetics (PK) of ozanimod and its major active metabolite, CC112273, in healthy adult subjects: gemfibrozil (strong inhibitor of CYP2C8), rifampin (mode...
What is the current status of trial NCT03624959?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2018-06-20. Estimated completion is 2018-08-10.
What interventions are being tested in trial NCT03624959?
The interventions under investigation include: Rifampin (DRUG), Itraconazole (DRUG), Ozanimod (DRUG), Gemfibrozil (DRUG).
Who is sponsoring clinical trial NCT03624959?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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