Open Label Pharmacokinetic Study of SAR302503 in Subjects With Hepatic Impairment

NCT01762462 | Completed Phase 1

• 2 other identifiers: POP13450U1111-1118-5554
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

Brief Summary

Primary Objective: To study the effect of mild and moderate hepatic impairment on the pharmacokinetics of SAR302503. Secondary Objective: To assess the tolerability of SAR302503 given as a single dose up to 300 mg in subjects with mild and moderate and hepatic impairment and in matched subjects with normal hepatic function.

Conditions

Hepatic 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) - Time Frame:

  16 days

Study Arms (1)

SAR302503

EXPERIMENTAL

single treatment with oral dose up to 300 mg of SAR302503

Drug: SAR302503

Interventions

SAR302503 DRUG

Pharmaceutical form:capsule Route of administration: oral

SAR302503

Eligibility Criteria

• Age: 18 Years - 75 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.
• 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 liver disease with Child-Pugh classification score between 5 and 9 assessed by medical history, physical examination, laboratory values
• lead ECG without clinically significant abnormality
• Laboratory parameters within the acceptable range for subjects with hepatic 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.
• Hepatocarcinoma.
• Acute hepatitis
• 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 gastric pH modifying agent
• Positive result on any of the following tests: anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).
• Positive result on urine drug screen
• Positive alcohol test.
• 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 840003

Miami, Florida, 33014, United States

Location

Investigational Site Number 840002

Orlando, Florida, 32809, United States

Location

Investigational Site Number 840001

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Interventions

fedratinib

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 7, 2013
• Study Start: December 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 5, 2025

Record last verified: 2013-08

Locations

US (3)