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Trial record 2 of 10 for:    lci699

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT02372084
First received: February 23, 2015
Last updated: March 16, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Hepatic Impairment
Drug: osilodrostat
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official 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

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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 Outcome Measures:
  • 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.

  • 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


Enrollment: 33
Actual Study Start Date: April 21, 2015
Study Completion Date: May 19, 2016
Primary Completion Date: May 19, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: osilodrostat (LCI699)
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).
Drug: osilodrostat
Other Name: LCI699

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02372084

Locations
United States, Florida
University of Miami / Clinical Research Services, Inc. Boynton Beach
Miami, Florida, United States, 33136
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
United States, Minnesota
DaVita Clinical Research
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02372084     History of Changes
Other Study ID Numbers: CLCI699C2103
Study First Received: February 23, 2015
Last Updated: March 16, 2017

Keywords provided by Novartis:
Hepatic impairment,
osilodrostat,
LCI699

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on March 28, 2017