Open Label Pharmacokinetic Study of SAR302503 in Subjects With Hepatic Impairment

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT01762462

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

5.7

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Impairment	Drug: SAR302503	Phase 1

Detailed Description

Study duration=17-35 days

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Dec 1, 2012

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SAR302503 single treatment with oral dose up to 300 mg of SAR302503	Drug: SAR302503 Pharmaceutical form:capsule Route of administration: oral

Arm

Intervention/Treatment

Experimental: SAR302503

single treatment with oral dose up to 300 mg of SAR302503

Drug: SAR302503

Pharmaceutical form:capsule Route of administration: oral

Outcome Measures

Primary Outcome Measures

Pharmacokinetic parameter: Cmax, AUClast and AUC [12 days]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational Site Number 840003	Miami	Florida	United States	33014
2	Investigational Site Number 840002	Orlando	Florida	United States	32809
3	Investigational Site Number 840001	Knoxville	Tennessee	United States	37920

Sponsors and Collaborators

Sanofi

Investigators

Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sanofi

ClinicalTrials.gov Identifier:

NCT01762462

Other Study ID Numbers:

POP13450
U1111-1118-5554

First Posted:

Jan 7, 2013

Last Update Posted:

Aug 29, 2013

Last Verified:

Aug 1, 2013

Additional relevant MeSH terms:

Liver Diseases

Study Results

No Results Posted as of Aug 29, 2013