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

Principia Biopharma

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers; Hepatic Function Abnormal

Treatments: Drug: Rilzabrutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06444204

POP17091 (Other Identifier)

PRN1008-020 (Other Identifier)

U1111-1260-4098 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 3 patient groups

Rilzabrutinib: Mild Hepatic Impairment

Experimental group

Description:

Subjects with mild Hepatic Impairment (HI)

Treatment:

Drug: Rilzabrutinib

Rilzabrutinib: Moderate Hepatic Impairment

Experimental group

Description:

Subjects with moderate Hepatic Impairment (HI)

Treatment:

Drug: Rilzabrutinib

Rilzabrutinib: Healthy-Matched Control

Experimental group

Description:

Subjects with normal hepatic function

Treatment:

Drug: Rilzabrutinib