Open Label Pharmacokinetic Study of SAR302503 in Subjects With Renal Impairment

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

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.