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

• Status: Completed
• Trial end date: 2016-05-19
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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 -