Open Label Pharmacokinetic Study of SAR302503 in Subjects With Renal Impairment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01763190
First received: January 4, 2013
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Renal 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, Moderate and Severe Renal Impairment, and in Matched Subjects With Normal Renal 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: 16 days ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: November 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SAR302503
single treatment of 300 mg oral dose of SAR302503
Drug: SAR302503

Pharmaceutical form:capsule

Route of administration: oral


Detailed Description:

study duration = 17 to 35 days

  Eligibility

Ages Eligible for Study:   18 Years to 79 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.
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763190

Locations
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
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01763190     History of Changes
Other Study ID Numbers: POP13449, U1111-1115-8416
Study First Received: January 4, 2013
Last Updated: September 11, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014