A Phase I Study of Osilodrostat (LCI699) in Healthy Volunteers and Subjects With Impaired Renal Function
NCT ID: NCT02399202
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
15 participants
INTERVENTIONAL
2015-11-06
2016-03-21
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 4 day treatment period ( a single 30 mg dose of LCI699 (Day 1) with 4 days of PK smple collection
osilodrostat
Interventions
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osilodrostat
Eligibility Criteria
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Inclusion Criteria
* Subjects must have stable renal disease without evidence of progressive decline in renal function (stable renal disease is defined as no significant change, such as, stable eGFR \<90 mL/min, for 12 weeks prior to study entry) Other than renal impairment, subjects must be stable and appropriately managed relative to chronic diseases (such as diabetes and hypertension)
Exclusion Criteria
* Subjects with ongoing alcohol or drug abuse within 1 month prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
* Subjects with screening 12-lead ECG QTcF of \> 450 msec for males or \> 460 msec for female
* History of diabetes mellitus (Type 1 or 2) or blood glucose of \>125 mg/dl at screening
* Subjects with potassium levels greater than the upper limit of normal (\>ULN)
Other protocol defined Inclusion/Exclusion may apply.
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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Novartis Investigative Site
Sofia, , Bulgaria
Novartis Investigative Site
Berlin, , Germany
Countries
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Related Links
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Results for CLCI699C2104 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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2014-003528-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLCI699C2104
Identifier Type: -
Identifier Source: org_study_id