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NCT06444204 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Single-Dose Pharmacokinetics of Rilzabrutinib (PRN1008)
A Phase 1 study, sponsored by Principia Biopharma, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT06444204: Completed Phase 1 study, sponsored by Principia Biopharma, a Sanofi Company.
NCT06444204 is a Phase 1 study that has completed, run by Principia Biopharma, a Sanofi Company. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06444204, a Phase 1 study, has completed, sponsored by Principia Biopharma, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
This is a single-dose study to assess the effect of mild or moderate Hepatic Impairment (HI) on the Pharmacokinetics (PK) of rilzabrutinib as well as to evaluate the safety and tolerability of rilzabrutinib in subjects with HI.
Interventions
- DRUG Rilzabrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2020-11-02 |
| Est. Completion | 2021-03-23 |
| Phase | Phase 1 |
What the finished NCT06444204 record still lists
NCT06444204 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 1 intervention - of which Rilzabrutinib is the first listed.
NCT06444204 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06444204 about?
NCT06444204 is a clinical study titled "A Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Single-Dose Pharmacokinetics of Rilzabrutinib (PRN1008)". This is a single-dose study to assess the effect of mild or moderate Hepatic Impairment (HI) on the Pharmacokinetics (PK) of rilzabrutinib as well as to evaluate the safety and tolerability of rilzabrutinib in subjects with HI.
What is the current status of trial NCT06444204?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2020-11-02. Estimated completion is 2021-03-23.
What interventions are being tested in trial NCT06444204?
The interventions under investigation include: Rilzabrutinib (DRUG).
Who is sponsoring clinical trial NCT06444204?
This trial is sponsored by Principia Biopharma, a Sanofi Company, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06444204's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 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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