Open Label Pharmacokinetic Study of SAR302503 in Subjects With Renal Impairment

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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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

36 participants in 1 patient group

SAR302503
Experimental group
Description:
single treatment of 300 mg oral dose of SAR302503
Treatment:
Drug: SAR302503

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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