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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-02

Study Completion Date

2021-03-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatic Function Abnormal Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rilzabrutinib: Mild Hepatic Impairment

Subjects with mild Hepatic Impairment (HI)

Group Type EXPERIMENTAL

Rilzabrutinib

Intervention Type DRUG

Rilzabrutinib tablet administered orally

Rilzabrutinib: Moderate Hepatic Impairment

Subjects with moderate Hepatic Impairment (HI)

Group Type EXPERIMENTAL

Rilzabrutinib

Intervention Type DRUG

Rilzabrutinib tablet administered orally

Rilzabrutinib: Healthy-Matched Control

Subjects with normal hepatic function

Group Type EXPERIMENTAL

Rilzabrutinib

Intervention Type DRUG

Rilzabrutinib tablet administered orally

Interventions

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Rilzabrutinib

Rilzabrutinib tablet administered orally

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes