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

Launched by PRINCIPIA BIOPHARMA, A SANOFI COMPANY · May 30, 2024

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * 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.
• Exclusion Criteria:
• * 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.

Trial Officials