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Open Label Pharmacokinetic Study of SAR302503 in Subjects With Renal Impairment

Primary Purpose

Renal Impairment

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

SAR302503

About this trial

This is an interventional treatment trial for Renal Impairment

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Investigational Site Number 840002
Investigational Site Number 840003
Investigational Site Number 840001

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SAR302503

Arm Description

single treatment of 300 mg oral dose of SAR302503

Outcomes

Primary Outcome Measures

Pharmacokinetic parameter: Cmax, AUClast and AUC

Secondary Outcome Measures

Pharmacokinetic parameters : unbound AUC, unbound Cmax, CL/F, Vss/F , t1/2z, t1/2eff, Rac, pred

Safety parameters including Clinical tests

Safety parameters including laboratory tests

Safety parameters including ECG parameters

Number of subjects with adverse events (AEs)

Full Information

NCT ID

NCT01763190

First Posted

January 4, 2013

Last Updated

May 12, 2015

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01763190

Brief Title

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

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SAR302503

Arm Type

Experimental

Arm Description

single treatment of 300 mg oral dose of SAR302503

Intervention Type

Drug

Intervention Name(s)

SAR302503

Intervention Description

Pharmaceutical form:capsule Route of administration: oral

Primary Outcome Measure Information:

Title

Pharmacokinetic parameter: Cmax, AUClast and AUC

Time Frame

12 days

Secondary Outcome Measure Information:

Title

Pharmacokinetic parameters : unbound AUC, unbound Cmax, CL/F, Vss/F , t1/2z, t1/2eff, Rac, pred

Time Frame

12 days

Title

Safety parameters including Clinical tests

Time Frame

16 days

Title

Safety parameters including laboratory tests

Time Frame

16 days

Title

Safety parameters including ECG parameters

Time Frame

16 days

Title

Number of subjects with adverse events (AEs)

Time Frame

16 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 840002

City

Orlando

State/Province

Florida

ZIP/Postal Code

32809

Country

United States

Facility Name

Investigational Site Number 840003

City

St. Paul

State/Province

Minnesota

ZIP/Postal Code

55144

Country

United States

Facility Name

Investigational Site Number 840001

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37920

Country

United States

12. IPD Sharing Statement

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Open Label Pharmacokinetic Study of SAR302503 in Subjects With Renal Impairment

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