Clinical trial NCT01763190: Open Label Pharmacokinetic Study of SAR302503 in Subjects With Renal Impairment
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2013-01-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Pharmacokinetic parameter: Cmax, AUClast and AUC
timeFrame: 12 days
Secondary outcomes:
measure: Pharmacokinetic parameters : unbound AUC, unbound Cmax, CL/F, Vss/F , t1/2z, t1/2eff, Rac, pred
timeFrame: 12 days
measure: Safety parameters including Clinical tests
timeFrame: 16 days
measure: Safety parameters including laboratory tests
timeFrame: 16 days
measure: Safety parameters including ECG parameters
timeFrame: 16 days
measure: Number of subjects with adverse events (AEs)
timeFrame: 16 days
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Investigational Site Number 840002
state: Florida
city: Saint Paul
country: United States
facility: Investigational Site Number 840003
state: Minnesota
city: Knoxville
country: United States
facility: Investigational Site Number 840001
state: Tennessee
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: