Phase
Condition
Healthy Volunteers
Primary Biliary Cholangitis
Treatment
BMS-986369
Clinical Study ID
Ages 18-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria for all Participants (Group A, Group B, Group C):
- Body mass index (BMI) between 18 and 40 kg/m^2 (inclusive), and body weight ≥ 50 kg.
Inclusion Criteria for Participants with Moderate or Severe Hepatic Impairment (Group A and Group B):
Participants have moderate HI (Group A), severe HI (Group B) or cirrhosis due to chronic hepatic disease and/or prior alcohol use.
Participants have moderate (Group A) or severe (Group B) HI as defined by National Cancer Institute-Organ Dysfunction Working Group (NCI-ODWG) criteria.
Inclusion Criteria for a Matched Healthy Participant (Group C):
Participants must have liver-related laboratory test results within the respective reference ranges or with clinically insignificant excursions as agreed by the investigator and the Sponsor Medical Monitor.
Participants must be free of any clinically significant disease that would interfere with the study evaluations.
Exclusion Criteria for all Participants (Group A, Group B, and Group C):
Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism, and excretion (ADME).
History of major surgery within 8 weeks before the study intervention administration.
Any other clinically significant medical, psychiatric, and/or social reason, or other active issues, as determined by the investigator.
Other protocol-defined Inclusion/Exclusion criteria apply.
Study Design
Connect with a study center
Arizona Liver Health
Chandler, Arizona 85225
United StatesActive - Recruiting
Local Institution - 0004
Chandler, Arizona 85225
United StatesSite Not Available
Local Institution - 0005
Orlando, Florida 32809
United StatesSite Not Available
Orlando Clinical Research Center
Orlando, Florida 32809
United StatesActive - Recruiting
Local Institution - 0006
San Antonio, Texas 78215
United StatesSite Not Available
Texas Liver Institute
San Antonio, Texas 78215
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.