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NCT06064539 · ClinicalTrials.gov registry record · Phase 1
Study of Drug-drug Interaction of the Effects of Gemfibrozil and Rifampicin on SAR442168 in Healthy Adult Subjects
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT06064539 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 30 participants.
The verdict
NCT06064539, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is a Phase 1, single-center, open-label, non-randomized study to assess the effects of CYP2C8 inhibition using gemfibrozil, and CYP3A4 and CYP2C8 induction using rifampicin on the pharmacokinetics of SAR442168 in healthy male participants aged 18 to 45 years.
Interventions
- DRUG Tolebrutinib
- DRUG rifampicin
- DRUG gemfibrozil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2020-05-18 |
| Est. Completion | 2020-07-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06064539
The ClinicalTrials.gov registry entry for NCT06064539 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Tolebrutinib is the first listed.
NCT06064539 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06064539 about?
NCT06064539 is a clinical study titled "Study of Drug-drug Interaction of the Effects of Gemfibrozil and Rifampicin on SAR442168 in Healthy Adult Subjects". This is a Phase 1, single-center, open-label, non-randomized study to assess the effects of CYP2C8 inhibition using gemfibrozil, and CYP3A4 and CYP2C8 induction using rifampicin on the pharmacokinetics of SAR442168 in healthy male participants aged 18 to 45 years.
What is the current status of trial NCT06064539?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2020-05-18. Estimated completion is 2020-07-08.
What interventions are being tested in trial NCT06064539?
The interventions under investigation include: Tolebrutinib (DRUG), rifampicin (DRUG), gemfibrozil (DRUG).
Who is sponsoring clinical trial NCT06064539?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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