Open Label Pharmacokinetic Study of SAR302503 in Subjects With Hepatic Impairment

Sanofi

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: SAR302503

Study type: Interventional

Funder types: Industry

Identifiers

NCT01762462

U1111-1118-5554 (Other Identifier)

POP13450

Details and patient eligibility

About

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.

Full description

Study duration=17-35 days

Enrollment: 17 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

SAR302503

Experimental group

Description:

single treatment with oral dose up to 300 mg of SAR302503

Treatment:

Drug: SAR302503