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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02399202
Other study ID # CLCI699C2104
Secondary ID 2014-003528-35
Status Completed
Phase Phase 1
First received
Last updated
Start date November 6, 2015
Est. completion date March 21, 2016

Study information

Verified date July 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To characterize the pharmacokinetics of LCI699 following a single oral dose in adult subjects with various degrees of impaired renal function.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date March 21, 2016
Est. primary completion date March 21, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Weight must be =50 kg and BMI must be between 18-35 kg/m2 - 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: - History of any surgical or medical condition other than renal impairment which might significantly alter the absorption, distribution, metabolism or excretion of drugs. - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
osilodrostat


Locations

Country Name City State
Bulgaria Novartis Investigative Site Sofia
Germany Novartis Investigative Site Berlin

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Bulgaria,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pharmacokinetics (PK in plasma) of a single dose of 30 mg osilodrostat: AUClast To assess the influence of renal impairment on the pharmacokinetics (PK) of LCI699i in subjects with varying degrees of renal impairment compared to subjects with normal renal function. Pre-dose (Day 0), and at timepoints 05.1,1.5,2,3,4,6,8,12,24,36,28 and 72 hours post dose
Primary Pharmacokinetics (PK in plasma) of a single dose of 30 mg osilodrostat: AUCinf To assess the influence of renal impairment on the pharmacokinetics (PK) of LCI699i in subjects with varying degrees of renal impairment compared to subjects with normal renal function. Pre-dose (Day 0), and at timepoints 05.1,1.5,2,3,4,6,8,12,24,36,28 and 72 hours post dose
Primary Pharmacokinetics (PK in plasma) of a single dose of 30 mg osilodrostat: Cmax To assess the influence of renal impairment on the pharmacokinetics (PK) of LCI699i in subjects with varying degrees of renal impairment compared to subjects with normal renal function. Pre-dose (Day 0), and at timepoints 05.1,1.5,2,3,4,6,8,12,24,36,28 and 72 hours post dose
Primary Pharmacokinetics (PK in urine) of a single dose of 30 mg osilodrostat: CL/F To assess the influence of renal impairment on the pharmacokinetics (PK) of LCI699i in subjects with varying degrees of renal impairment compared to subjects with normal renal function. Pre-dose (Day 0), and at timepoints 05.1,1.5,2,3,4,6,8,12,24,36,28 and 72 hours post dose
Secondary The relationship between PK parameters (, T1/2, V2/F and urine AeOt) Pre-dose (Day 0), and at timepoints 05.1,1.5,2,3,4,6,8,12,24,36,28 and 72 hours post dose
Secondary Number of participants with adverse events Pre-treatment, during treatment (Day1) and 30 days post treatment
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