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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: Completed Phase 1 study, sponsored by Sanofi.
NCT06064539 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
AUC up to the last measurable concentration
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 |
What the finished NCT06064539 record still lists
NCT06064539 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 3 interventions - of which Tolebrutinib is the first listed.
NCT06064539 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06064539's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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