Open Label Pharmacokinetic Study of SAR302503 in Subjects With Renal Impairment

Renal Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01763190
• Other study ID #: POP13449
• Secondary ID: U1111-1115-8416
• Status: Completed
• Phase: Phase 1
• First received: January 4, 2013
• Last updated: May 12, 2015
• Start date: November 2012
• Est. completion date: July 2013

Study information

• Verified date: May 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

study duration = 17 to 35 days

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• SAR302503
Pharmaceutical form:capsule Route of administration: oral

Locations

Country	Name	City	State
United States	Investigational Site Number 840001	Knoxville	Tennessee
United States	Investigational Site Number 840002	Orlando	Florida
United States	Investigational Site Number 840003	St. Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameter: Cmax, AUClast and AUC		12 days	No
Secondary	Pharmacokinetic parameters : unbound AUC, unbound Cmax, CL/F, Vss/F , t1/2z, t1/2eff, Rac, pred		12 days	No
Secondary	Safety parameters including Clinical tests		16 days	Yes
Secondary	Safety parameters including laboratory tests		16 days	Yes
Secondary	Safety parameters including ECG parameters		16 days	Yes
Secondary	Number of subjects with adverse events (AEs)		16 days	Yes