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Open Label Pharmacokinetic Study of SAR302503 in Subjects With Hepatic Impairment

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ClinicalTrials.gov Identifier: NCT01762462
Recruitment Status : Completed
First Posted : January 7, 2013
Last Update Posted : August 29, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi

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 Type : Interventional  (Clinical Trial)
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 : December 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

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




Primary Outcome Measures :
  1. Pharmacokinetic parameter: Cmax, AUClast and AUC [ Time Frame: 12 days ]

Secondary Outcome Measures :
  1. Pharmacokinetic parameters : unbound AUC, unbound Cmax, CL/F, Vss/F , t1/2z, t1/2eff, Rac, pred [ Time Frame: 12 days ]
  2. Safety parameters including Clinical tests [ Time Frame: 16 days ]
  3. Safety parameters including laboratory tests [ Time Frame: 16 days ]
  4. Safety parameters including ECG parameters [ Time Frame: 16 days ]
  5. Number of subjects with adverse events (AEs) - Time Frame: [ Time Frame: 16 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01762462     History of Changes
Other Study ID Numbers: POP13450
U1111-1118-5554 ( Other Identifier: UTN )
First Posted: January 7, 2013    Key Record Dates
Last Update Posted: August 29, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases