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

Completed · Phase 1

Conditions studied: Hepatic Impairment

In brief

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.

Key facts

Study ID: NCT02372084
Run by: Novartis Pharmaceuticals
People needed: 33
Starts: 2015-04-21
Expected to finish: 2016-05-19
Last updated by the study team: 2020-12-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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 -

Where it is running

University of Miami / Clinical Research Services, Inc. Boynton Beach — Miami, Florida, United States
Orlando Clinical Research Center — Orlando, Florida, United States
DaVita Clinical Research — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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