Open Label Pharmacokinetic Study of SAR302503 in Subjects With Hepatic Impairment

Hepatic Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01762462
• Other study ID #: POP13450
• Secondary ID: U1111-1118-5554
• Status: Completed
• Phase: Phase 1
• First received: January 4, 2013
• Last updated: August 28, 2013
• Start date: December 2012
• Est. completion date: March 2013

Study information

• Verified date: August 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Study duration=17-35 days

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• SAR302503
Pharmaceutical form:capsule Route of administration: oral

Locations

Country	Name	City	State
United States	Investigational Site Number 840001	Knoxville	Tennessee
United States	Investigational Site Number 840003	Miami	Florida
United States	Investigational Site Number 840002	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameter: Cmax, AUClast and AUC		12 days	No
Secondary	Pharmacokinetic parameters : unbound AUC, unbound Cmax, CL/F, Vss/F , t1/2z, t1/2eff, Rac, pred		12 days	No
Secondary	Safety parameters including Clinical tests		16 days	Yes
Secondary	Safety parameters including laboratory tests		16 days	Yes
Secondary	Safety parameters including ECG parameters		16 days	Yes
Secondary	Number of subjects with adverse events (AEs) - Time Frame:		16 days	Yes