Skip to main content
OpenTrials
Completed

NCT Number: NCT02372084

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatic Impairment

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Osilodrostat

Drug

Other names: LCI699

Primary outcomes

  1. Pharmacokinetics (PK) of a single dose of 30 mg osilodrostat: AUClast

    Time frame: 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.

  2. PK of a single dose of 30 mg osilodrostat: AUCinf

    Time frame: 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.

  3. PK of a single dose of 30 mg osilodrostat: Cmax

    Time frame: 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.

  4. PK of a single dose of 30 mg osilodrostat: T1/2

    Time frame: 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.

  5. PK of a single dose of 30 mg osilodrostat: CL/F

    Time frame: 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.

  6. PK of a single dose of 30 mg osilodrostat: Vz/F

    Time frame: 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.

Secondary outcomes

  1. The relationship between PK parameters (Cmax and AUC) and baseline hepatic function parameters namely; total bilirubin, albumin, INR (or prothrombin, if INR unavailable)

    Time frame: 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.

  2. Number of participants with adverse events (AEs)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 26, 2015
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.