A Phase 1 Study of Osilodrostat (LCI699) in Healthy Volunteers and Subjects With Impaired Hepatic Function
NCT ID: NCT02372084
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
33 participants
INTERVENTIONAL
2015-04-21
2016-05-19
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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).
osilodrostat
Interventions
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osilodrostat
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable liver cirrhosis and evidence of hepatic impairment.
* Free of significant medical disorders unrelated to underlying hepatic impairment
Exclusion Criteria
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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University of Miami / Clinical Research Services, Inc. Boynton Beach
Miami, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
DaVita Clinical Research
Minneapolis, Minnesota, United States
Countries
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Related Links
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Novartis results database
Other Identifiers
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CLCI699C2103
Identifier Type: -
Identifier Source: org_study_id