NCT06444204

A Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Single-Dose Pharmacokinetics of Rilzabrutinib (PRN1008)

An Open-Label, Phase 1 Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Single-Dose Pharmacokinetics of Rilzabrutinib (PRN1008)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Principia Biopharma, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatic Function Abnormal
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Rilzabrutinib	Rilzabrutinib tablet administered orally

Timeline

• Start date: 2020-11-02
• Primary completion: 2021-03-23
• Completion: 2021-03-23
• First posted: 2024-06-05
• Last updated: 2024-06-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study