Open Label Pharmacokinetic Study of SAR302503 in Subjects With Renal Impairment

Sanofi

Status and phase

Completed

Phase 1

Conditions

Renal Impairment

Treatments

Drug: SAR302503

Study type

Interventional

Funder types

Industry

Identifiers

NCT01763190

U1111-1115-8416 (Other Identifier)

POP13449

Details and patient eligibility

About

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.

Full description

study duration = 17 to 35 days

Enrollment

36 patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.