Open Label Pharmacokinetic Study of SAR302503 in Subjects With Hepatic Impairment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01762462
First received: January 4, 2013
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Hepatic Impairment
Drug: SAR302503
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Pharmacokinetic parameter: Cmax, AUClast and AUC [ Time Frame: 12 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters : unbound AUC, unbound Cmax, CL/F, Vss/F , t1/2z, t1/2eff, Rac, pred [ Time Frame: 12 days ] [ Designated as safety issue: No ]
  • Safety parameters including Clinical tests [ Time Frame: 16 days ] [ Designated as safety issue: Yes ]
  • Safety parameters including laboratory tests [ Time Frame: 16 days ] [ Designated as safety issue: Yes ]
  • Safety parameters including ECG parameters [ Time Frame: 16 days ] [ Designated as safety issue: Yes ]
  • Number of subjects with adverse events (AEs) - Time Frame: [ Time Frame: 16 days ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: December 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SAR302503
single treatment with oral dose up to 300 mg of SAR302503
Drug: SAR302503

Pharmaceutical form:capsule

Route of administration: oral


Detailed Description:

Study duration=17-35 days

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01762462

Locations
United States, Florida
Investigational Site Number 840003
Miami, Florida, United States, 33014
Investigational Site Number 840002
Orlando, Florida, United States, 32809
United States, Tennessee
Investigational Site Number 840001
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01762462     History of Changes
Other Study ID Numbers: POP13450, U1111-1118-5554
Study First Received: January 4, 2013
Last Updated: August 28, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 16, 2014