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NCT06106074 · ClinicalTrials.gov registry record · Phase 1
Study of the Tolerability and Pharmacokinetics of Oral Doses of SAR442168 With a Food Effect Investigation in Healthy Adult Participants
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 71
- Enrollment target
NCT06106074: Completed Phase 1 study, sponsored by Sanofi.
NCT06106074 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 71 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06106074, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 71 participants
- Enrollment target
Study Summary
This is a randomized, placebo-controlled, four-part, Phase I, first in human (FIH) study to assess the tolerability and pharmacokinetics (PK) of ascending single and 14-day repeated oral doses of SAR442168 with a food effect investigation in healthy adult participants. * In Part 1a: The tolerability and safety of SAR442168 and the pharmacokinetic parameters of SAR442168 and metabolite(s)after ascending single oral doses in fasted and fed conditions * In Part 1b: The relationship of PK of SAR442168 and metabolite(s) in cerebrospinal fluid (CSF) to that in plasma after single oral doses given in fed conditions (moderate-fat meal) * In Part 1c: The effect of a high-fat meal on the pharmacokinetics of SAR442168 and metabolite(s) (high-fat) * In Part 1d: The effect of a high-fat meal on the pharmacokinetics of SAR442168 and metabolite(s) (standardized high-fat meal) * In Part 2: The tolerability and safety of SAR442168 and the pharmacokinetic parameters of SAR442168 and metabolite(s) after 14-day ascending repeated oral doses of SAR442168 given in fed conditions (moderate-fat meal).
Interventions
- DRUG Placebo
- DRUG Tolebrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2020-08-10 |
| Est. Completion | 2022-05-23 |
| Phase | Phase 1 |
What the finished NCT06106074 record still lists
NCT06106074 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06106074 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06106074 about?
NCT06106074 is a clinical study titled "Study of the Tolerability and Pharmacokinetics of Oral Doses of SAR442168 With a Food Effect Investigation in Healthy Adult Participants". This is a randomized, placebo-controlled, four-part, Phase I, first in human (FIH) study to assess the tolerability and pharmacokinetics (PK) of ascending single and 14-day repeated oral doses of SAR442168 with a food effect investigation in healthy adult participants. * In Part 1a: The tolerabilit...
What is the current status of trial NCT06106074?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 71 participants. The study started on 2020-08-10. Estimated completion is 2022-05-23.
What interventions are being tested in trial NCT06106074?
The interventions under investigation include: Placebo (DRUG), Tolebrutinib (DRUG).
Who is sponsoring clinical trial NCT06106074?
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 NCT06106074's enrollment target sits among peer trials
71 747th of 2000 higher than 1,252 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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