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

Novartis

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: osilodrostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT02372084

CLCI699C2103

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

osilodrostat (LCI699)

Experimental group

Description:

Each participant will undergo a 28-day screening/baseline period (day -28 to day -1), followed by a 5 day treatment period (a single 30 mg dose of LCI699 ( Day 1) with 5 days of PK sample collection).

Treatment:

Drug: osilodrostat