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Open Label Pharmacokinetic Study of SAR302503 in Subjects With Hepatic Impairment

Primary Purpose

Hepatic Impairment

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

SAR302503

About this trial

This is an interventional treatment trial for Hepatic Impairment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Investigational Site Number 840003
Investigational Site Number 840002
Investigational Site Number 840001

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SAR302503

Arm Description

single treatment with oral dose up to 300 mg of SAR302503

Outcomes

Primary Outcome Measures

Pharmacokinetic parameter: Cmax, AUClast and AUC

Secondary Outcome Measures

Pharmacokinetic parameters : unbound AUC, unbound Cmax, CL/F, Vss/F , t1/2z, t1/2eff, Rac, pred

Safety parameters including Clinical tests

Safety parameters including laboratory tests

Safety parameters including ECG parameters

Number of subjects with adverse events (AEs) - Time Frame:

Full Information

NCT ID

NCT01762462

First Posted

January 4, 2013

Last Updated

August 28, 2013

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01762462

Brief Title

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

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. 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.

Detailed Description

Study duration=17-35 days

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SAR302503

Arm Type

Experimental

Arm Description

single treatment with oral dose up to 300 mg of SAR302503

Intervention Type

Drug

Intervention Name(s)

SAR302503

Intervention Description

Pharmaceutical form:capsule Route of administration: oral

Primary Outcome Measure Information:

Title

Pharmacokinetic parameter: Cmax, AUClast and AUC

Time Frame

12 days

Secondary Outcome Measure Information:

Title

Pharmacokinetic parameters : unbound AUC, unbound Cmax, CL/F, Vss/F , t1/2z, t1/2eff, Rac, pred

Time Frame

12 days

Title

Safety parameters including Clinical tests

Time Frame

16 days

Title

Safety parameters including laboratory tests

Time Frame

16 days

Title

Safety parameters including ECG parameters

Time Frame

16 days

Title

Number of subjects with adverse events (AEs) - Time Frame:

Time Frame

16 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 840003

City

Miami

State/Province

Florida

ZIP/Postal Code

33014

Country

United States

Facility Name

Investigational Site Number 840002

City

Orlando

State/Province

Florida

ZIP/Postal Code

32809

Country

United States

Facility Name

Investigational Site Number 840001

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37920

Country

United States

12. IPD Sharing Statement

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Open Label Pharmacokinetic Study of SAR302503 in Subjects With Hepatic Impairment

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