Open Label Pharmacokinetic Study of SAR302503 in Subjects With Hepatic Impairment

An Open-label, Pharmacokinetic and Tolerability Study of SAR302503 Given as a Single 300 mg Dose in Subjects With Mild and Moderate Hepatic Impairment, and in Matched Subjects With Normal Hepatic Function

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01762462

Enrollment

Registered

2013-01-07

Start date

2012-12-31

Completion date

2013-03-31

Last updated

2025-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Impairment

Brief summary

Primary Objective: To study the effect of mild and moderate hepatic impairment on the pharmacokinetics of SAR302503. Secondary Objective: To assess the tolerability of SAR302503 given as a single dose up to 300 mg in subjects with mild and moderate and hepatic impairment and in matched subjects with normal hepatic function.

Detailed description

Study duration=17-35 days

Interventions

DRUGSAR302503

Pharmaceutical form:capsule Route of administration: oral

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

: * Male or female subjects, between 18 and 75 years of age, inclusive. * Body weight between 50.0 and 115.0 kg, inclusive if male, and between 40.0 and 100.0 kg, inclusive if female, body mass index between 18.0 and 34.9 kg/m2, inclusive. * Stable chronic liver disease with Child-Pugh classification score between 5 and 9 assessed by medical history, physical examination, laboratory values * 12-lead ECG without clinically significant abnormality * Laboratory parameters within the acceptable range for subjects with hepatic impairment * Using a double contraception method

Exclusion criteria

* Uncontrolled clinically relevant cardiovascular, pulmonary, gastrointestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness. * Hepatocarcinoma. * Acute hepatitis * Any significant change in chronic treatment medication within 14 days before inclusion * Concomitant treatment with or use of drugs or herbal agents known to be at least moderate inhibitors or inducers CYP3A4 sensitive or narrow therapeutic index substrate of CYP3A4 * Concomitant treatment gastric pH modifying agent * Positive result on any of the following tests: anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab). * Positive result on urine drug screen * Positive alcohol test. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic parameter: Cmax, AUClast and AUC	12 days

Secondary

Measure	Time frame
Pharmacokinetic parameters : unbound AUC, unbound Cmax, CL/F, Vss/F , t1/2z, t1/2eff, Rac, pred	12 days
Safety parameters including Clinical tests	16 days
Safety parameters including laboratory tests	16 days
Safety parameters including ECG parameters	16 days
Number of subjects with adverse events (AEs) - Time Frame:	16 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026