Open Label Pharmacokinetic Study of SAR302503 in Subjects With Renal Impairment

NCT ID: NCT01763190

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-07-31

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.

Detailed Description

study duration = 17 to 35 days

Conditions

Renal Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SAR302503

single treatment of 300 mg oral dose of SAR302503

Group Type: EXPERIMENTAL

SAR302503

Intervention Type: DRUG

Pharmaceutical form:capsule

Route of administration: oral

Interventions

SAR302503

Pharmaceutical form:capsule

Route of administration: oral

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 840002

Orlando, Florida, United States

Investigational Site Number 840003

Saint Paul, Minnesota, United States

Investigational Site Number 840001

Knoxville, Tennessee, United States

Countries

United States

Other Identifiers

U1111-1115-8416

Identifier Type: OTHER

Identifier Source: secondary_id

POP13449

Identifier Type: -

Identifier Source: org_study_id