Open Label Pharmacokinetic Study of SAR302503 in Subjects With Renal Impairment

NCT01763190 | Completed Phase 1

• 2 other identifiers: POP13449U1111-1115-8416
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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.

Conditions

Renal Impairment

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic parameter: Cmax, AUClast and AUC

  12 days

Secondary Outcomes (5)

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

  12 days

• Safety parameters including Clinical tests

  16 days

• Safety parameters including laboratory tests

  16 days

• Safety parameters including ECG parameters

  16 days

• Number of subjects with adverse events (AEs)

  16 days

Study Arms (1)

SAR302503

EXPERIMENTAL

single treatment of 300 mg oral dose of SAR302503

Drug: SAR302503

Interventions

SAR302503 DRUG

Pharmaceutical form:capsule Route of administration: oral

SAR302503

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (3)

Investigational Site Number 840002

Orlando, Florida, 32809, United States

Location

Investigational Site Number 840003

Saint Paul, Minnesota, 55144, United States

Location

Investigational Site Number 840001

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

fedratinib

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2013
• First Posted: January 8, 2013
• Study Start: November 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: March 5, 2025

Record last verified: 2015-05

Locations

US (3)