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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 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 28 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06342700
The ClinicalTrials.gov registry entry for NCT06342700 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 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 2 interventions - of which Rilzabrutinib crystalline form is the first listed.
NCT06342700 reports 0 study locations.
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.
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