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NCT06342700 · ClinicalTrials.gov registry record · Phase 1
A Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT06342700: Completed Phase 1 study, sponsored by Sanofi.
NCT06342700 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06342700, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
This is a cross-over, Phase 1, 4-arm study. The purpose of this study is to measure the relative bioavailability and food effect of crystalline formulation rilzabrutinib and amorphous formulation rilzabrutinib in healthy male and female participants aged 18 to 55 years of age. The total study duration per participant is expected to be up to 36 days, including: * Screening: up to 4 weeks * Treatment periods: once successfully screened, enrolled participants will be randomized to 1 of 4 treatment sequences with 4 single dose treatment periods. * Washout: One day washout is planned after each treatment period hence providing 2 days between doses. * Safety follow-up: participants will be asked to participate in an end-of-study safety assessment upon discharge from the clinical study unit, ie, on Day 8 of the study.
Primary Outcome
Cmax: maximum plasma concentration
Interventions
- DRUG Rilzabrutinib crystalline form
- DRUG Rilzabrutinib amorphous form
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2024-03-25 |
| Est. Completion | 2024-04-23 |
| Phase | Phase 1 |
What the finished NCT06342700 record still lists
NCT06342700 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Rilzabrutinib crystalline form is the first listed.
NCT06342700 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06342700 about?
NCT06342700 is a clinical study titled "A Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants". This is a cross-over, Phase 1, 4-arm study. The purpose of this study is to measure the relative bioavailability and food effect of crystalline formulation rilzabrutinib and amorphous formulation rilzabrutinib in healthy male and female participants aged 18 to 55 years of age. The total study durat...
What is the current status of trial NCT06342700?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2024-03-25. Estimated completion is 2024-04-23.
What interventions are being tested in trial NCT06342700?
The interventions under investigation include: Rilzabrutinib crystalline form (DRUG), Rilzabrutinib amorphous form (DRUG).
Who is sponsoring clinical trial NCT06342700?
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 NCT06342700's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 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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