Clinical trial NCT01762462: Open Label Pharmacokinetic Study of SAR302503 in Subjects With Hepatic Impairment
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2013-01-07
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: Pharmacokinetic parameter: Cmax, AUClast and AUC
timeFrame: 12 days
Secondary outcomes:
measure: Pharmacokinetic parameters : unbound AUC, unbound Cmax, CL/F, Vss/F , t1/2z, t1/2eff, Rac, pred
timeFrame: 12 days
measure: Safety parameters including Clinical tests
timeFrame: 16 days
measure: Safety parameters including laboratory tests
timeFrame: 16 days
measure: Safety parameters including ECG parameters
timeFrame: 16 days
measure: Number of subjects with adverse events (AEs) - Time Frame:
timeFrame: 16 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Investigational Site Number 840003
state: Florida
city: Orlando
country: United States
facility: Investigational Site Number 840002
state: Florida
city: Knoxville
country: United States
facility: Investigational Site Number 840001
state: Tennessee
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: