Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by Principia Biopharma, a Sanofi Company. The registered enrollment target is 29 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06444204
The ClinicalTrials.gov registry entry for NCT06444204 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Principia Biopharma, a Sanofi Company, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Rilzabrutinib is the first listed.
NCT06444204 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.