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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02372084

Enrollment

Registered

2015-02-26

Start date

2015-04-21

Completion date

2016-05-19

Last updated

2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Impairment

Keywords

Hepatic impairment,, osilodrostat,, LCI699

Brief 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.

Interventions

DRUGosilodrostat

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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/

Design outcomes

Primary

Measure	Time frame	Description
PK of a single dose of 30 mg osilodrostat: Vz/F	Predose (Day 0) , and timepoints 0.5, 1, 1.5, 2, 3,4, 6, 8, 12, 24, 36, 48, 72, 96 hours post dose.	To assess the influence of hepatic impairment on the pharmacokinetics (PK) of LCI699i in subjects with varying degrees of hepatic impairment compared to subjects with normal hepatic function.
PK of a single dose of 30 mg osilodrostat: T1/2	Predose (Day 0) , and at timepoints 0.5, 1, 1.5, 2, 3,4, 6, 8, 12, 24, 36, 48, 72, 96 hours post dose.	To assess the influence of hepatic impairment on the pharmacokinetics (PK) of LCI699i in subjects with varying degrees of hepatic impairment compared to subjects with normal hepatic function.
PK of a single dose of 30 mg osilodrostat: CL/F	Predose (Day 0) , and at timepoints 0.5, 1, 1.5, 2, 3,4, 6, 8, 12, 24, 36, 48, 72, 96 hours post dose.	To assess the influence of hepatic impairment on the pharmacokinetics (PK) of LCI699i in subjects with varying degrees of hepatic impairment compared to subjects with normal hepatic function.
Pharmacokinetics (PK) of a single dose of 30 mg osilodrostat: AUClast	Predose (Day 0) , and at timepoints 0.5, 1, 1.5, 2, 3,4, 6, 8, 12, 24, 36, 48, 72, 96 hours post dose.	To assess the influence of hepatic impairment on the pharmacokinetics (PK) of LCI699i in subjects with varying degrees of hepatic impairment compared to subjects with normal hepatic function.
PK of a single dose of 30 mg osilodrostat: AUCinf	Predose (Day 0) , and at imepoints 0.5, 1, 1.5, 2, 3,4, 6, 8, 12, 24, 36, 48, 72, 96 hours post dose.	To assess the influence of hepatic impairment on the pharmacokinetics (PK) of LCI699i in subjects with varying degrees of hepatic impairment compared to subjects with normal hepatic function.
PK of a single dose of 30 mg osilodrostat: Cmax	Predose (Day 0) , and at timepoints 0.5, 1, 1.5, 2, 3,4, 6, 8, 12, 24, 36, 48, 72, 96 hours post dose.	To assess the influence of hepatic impairment on the pharmacokinetics (PK) of LCI699i in subjects with varying degrees of hepatic impairment compared to subjects with normal hepatic function.

Secondary

Measure	Time frame	Description
Number of participants with adverse events (AEs)	Pre-treatment, during treatment (Day 1) and 30 days post treatment.	This will be assessed using laboratory abnormalities, ECG and vital sign assessments of a single 30 mg dose of LCI699
The relationship between PK parameters (Cmax and AUC) and baseline hepatic function parameters namely; total bilirubin, albumin, INR (or prothrombin, if INR unavailable)	Predose ( Day 0) and at timepoints 0.5, 1, 1.5, 2, 3,4, 6, 8, 12, 24, 36, 48, 72, 96 hours post dose.	To evaluate the relationship between hepatic function parameters and pharmacokinetics.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026