Renal Impairment
Conditions
Keywords
Renal impairment, osilodrostat, LCI699
Brief summary
To characterize the pharmacokinetics of LCI699 following a single oral dose in adult subjects with various degrees of impaired renal function.
Interventions
DRUGosilodrostat
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Bulgaria, Germany
Outcome results
None listed