A Phase 1 Study of Osilodrostat (LCI699) in Healthy Volunteers and Subjects With Impaired Hepatic Function

Status:	Completed
Conditions:	Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	18 - 75
Updated:	3/18/2017
Start Date:	April 21, 2015
End Date:	May 19, 2016

A Phase I, Open-label, Multi-center, Single Dose, Parallel Group Study to Evaluate the Pharmacokinetics and Safety of Osilodrostat (LCI699) in Subjects With Impaired Hepatic Function Compared to Subjects With Normal Hepatic Function

To assess the pharmacokinetics of a single oral dose of osilodrostat (LCI699) 30 mg in
subjects with mild, moderate and severe hepatic impairment compared with subjects with
normal hepatic function.

Inclusion Criteria:

- Weight ≥50 kg and BMI between 18-38kg/m2.

- Stable liver cirrhosis and evidence of hepatic impairment. ‐Free of significant
medical disorders unrelated to underlying hepatic impairment

Exclusion Criteria:

- History of any surgical or medical condition which might significantly alter the
absorption, distribution, metabolism or excretion of drugs

- Subjects with ongoing alcohol or drug abuse

- Symptoms or history of encephalopathy (Grade 2 or above)

- History or presence of liver disease or liver injury (healthy volunteers only)

- History or presence of impaired renal function

- Clinical evidence of severe ascites.

- Total Bilirubin > 6 mg/dL,

- Subjects with a serum free cortisol test results that is below the lower limit
of normal (based on central laboratory) during the screening period

- Concomitant use of a drug that is a strong inducer of the CYP3A4/5 pathway

Other protocol-defined inclusion/exclusion criteria may apply -

We found this trial at

sites

University of Miami / Clinical Research Services, Inc. Boynton Beach

Miami, Florida 33136

Principal Investigator: Richard A. Preston

Phone: 561-737-3954

from

Miami, FL