Phase
Condition
Primary Biliary Cholangitis
Liver Failure
Liver Disease
Treatment
Imlunestrant
Clinical Study ID
Ages > 18 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: All Participants:
Women not of childbearing potential may participate and include those who areinfertile due to surgical sterilization (hysterectomy, bilateral oophorectomy,bilateral salpingectomy or tubal ligation), congenital anomaly such as mullerianagenesis; or postmenopausal
Are between the body mass index (BMI) of 18.0 and 42.0 kilograms per meter squared (kg/m²), inclusive, at screening Healthy Participants:
Healthy females as determined by medical history, physical examination, and otherscreening procedures, with normal liver function Participants with Impaired Liver Function:
Females with chronic mild, moderate and severe liver impairment, assessed byChild-Pugh scoring
Have diagnosis of chronic hepatic impairment (>6 months), with no clinicallysignificant changes within 90 days prior to study drug administration.
Exclusion
Exclusion Criteria:
- Women of childbearing potential are excluded from the study.
- Have known allergies to imlunestrant or related compounds
- Have a history of alcoholism or drug/chemical abuse within 2 years prior to check-in
- Have received blood products within 2 months prior to check-in
- Have evidence of HIV infection and/or positive human HIV antibodies
- Have used or intend to use medications that are strong inhibiters or inducers ofcytochrome P450 (CYP)3A4
- Who smoke more than 10 cigarettes or use the equivalent tobacco, smoking-cessationproducts, nicotine-containing products, or e-cigarettes (nicotine and non-nicotine)per day.
- Have a history or presence of cardiovascular (eg, symptomatic bradycardia with restingheart rate of <60 beats per minute), respiratory, renal, gastrointestinal, endocrine,hematological, or neurological disorders capable of significantly altering theabsorption, metabolism, or elimination of drugs
Study Design
Connect with a study center
Inland Empire Liver Foundation
Rialto, California 92377
United StatesSite Not Available
Orlando Clinical Research Center
Orlando, Florida 32809
United StatesSite Not Available
American Research Corporation at Texas Liver Institute
San Antonio, Texas 78215
United StatesSite Not Available
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