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Open Label Pharmacokinetic Study of SAR302503 in Subjects With Renal Impairment

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ClinicalTrials.gov Identifier: NCT01763190
Recruitment Status : Completed
First Posted : January 8, 2013
Last Update Posted : May 13, 2015
Information provided by (Responsible Party):

Brief Summary:

Primary Objective:

To study the effect of mild, moderate and severe renal impairment on the pharmacokinetics of SAR302503.

Secondary Objective:

To assess the tolerability of SAR302503 given as a single 300 mg dose in subjects with mild, moderate and severe renal impairment and in matched subjects with normal renal function.

Condition or disease Intervention/treatment Phase
Renal Impairment Drug: SAR302503 Phase 1

Detailed Description:
study duration = 17 to 35 days

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 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, Moderate and Severe Renal Impairment, and in Matched Subjects With Normal Renal Function
Study Start Date : November 2012
Primary Completion Date : July 2013
Study Completion Date : July 2013

Arm Intervention/treatment
Experimental: SAR302503
single treatment of 300 mg oral dose 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: 16 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria :

  • Male or female subjects, between 18 and 75 years of age, inclusive.
  • For subjects between ages 75 to 79 with the approval from sponsor's medical monitor.
  • 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 renal impairment, as defined by Cockcroft-Gault formula;
  • Laboratory parameters within the acceptable range for subjects with renal 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
  • Active hepatitis, hepatic insufficiency
  • Acute renal failure (de novo or superimposed to preexisting chronic renal impairment), nephrotic syndrome
  • History of or current hematuria of urologic origin that limits the subject's participation in the study
  • Subjects requiring dialysis during the study.
  • 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 with gastric pH modifying agents (proton pump inhibitors and H2-blockers) is not allowed 7 days prior to and 6 hours after study drug treatment

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): NCT01763190

United States, Florida
Investigational Site Number 840002
Orlando, Florida, United States, 32809
United States, Minnesota
Investigational Site Number 840003
St. Paul, Minnesota, United States, 55144
United States, Tennessee
Investigational Site Number 840001
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01763190     History of Changes
Other Study ID Numbers: POP13449
U1111-1115-8416 ( Other Identifier: UTN )
First Posted: January 8, 2013    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases