A Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Single-Dose Pharmacokinetics of Rilzabrutinib (PRN1008)
Completed · Phase 1
Conditions studied: Hepatic Function Abnormal, Healthy Volunteers
In brief
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.
Key facts
- Study ID
- NCT06444204
- Run by
- Principia Biopharma, a Sanofi Company
- People needed
- 29
- Starts
- 2020-11-02
- Expected to finish
- 2021-03-23
- Last updated by the study team
- 2024-06-05
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Hepatic Impaired Subjects:
- Non-smoking or light smoker (not exceeding 5 cigarettes per day), adult male or non-pregnant, non-lactating female, 18-75 years of age, inclusive, at screening.
- Weight ≥ 50 kg, at screening.
- Healthy Subjects:
- Non-smoking or light smoker (not exceeding 5 cigarettes per day), healthy, adult males and non-pregnant, non-lactating females, 18-75 years of age, inclusive, at screening.
- Subject must be matched for age (within ± 10 years), and sex of the matched subject with hepatic impairment.
- -Weight ≥ 50 kg at screening.
- Additional inclusion criteria might apply.
You may not qualify if…
- Hepatic Impaired Subjects:
- Pregnant or lactating female.
- Uncontrolled treated/untreated hypertension (systolic blood pressure ≥ 160 millimeters of mercury [mmHg] and/or diastolic blood pressure ≥ 105 mmHg), or resting pulse rate < 45 or > 100 beats per minute (bpm). Measurements may be repeated once in order to determine eligibility.
- Healthy Subjects
- Pregnant or lactating female.
- Uncontrolled treated/untreated hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 105 mmHg), or resting pulse rate < 45 or > 100 bpm. Measurements may be repeated once in order to determine eligibility.
- Additional exclusion criteria might apply.
Where it is running
- Investigational Site Number: 0002 — Miami, Florida, United States
- Investigational Site Number: 0001 — Orlando, Florida, United States
Full record on ClinicalTrials.gov
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