A Phase I Study of Osilodrostat (LCI699) in Healthy Volunteers and Subjects With Impaired Renal Function
- Registration Number
- NCT02399202
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
To characterize the pharmacokinetics of LCI699 following a single oral dose in adult subjects with various degrees of impaired renal function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- 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)
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description osilodrostat ( LCI699) osilodrostat 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
- Primary Outcome Measures
Name Time Method Pharmacokinetics (PK in plasma) of a single dose of 30 mg osilodrostat: AUClast 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 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.
Pharmacokinetics (PK in plasma) of a single dose of 30 mg osilodrostat: AUCinf 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 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.
Pharmacokinetics (PK in plasma) of a single dose of 30 mg osilodrostat: Cmax 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 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.
Pharmacokinetics (PK in urine) of a single dose of 30 mg osilodrostat: CL/F 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 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.
- Secondary Outcome Measures
Name Time Method 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 Number of participants with adverse events Pre-treatment, during treatment (Day1) and 30 days post treatment
Trial Locations
- Locations (1)
Novartis Investigative Site
🇩🇪Berlin, Germany