Clinical trial NCT02399202: A Phase I Study of Osilodrostat (LCI699) in Healthy Volunteers and Subjects With Impaired Renal Function
Official title: A Phase I, Open-label, Multi-center, Single Dose, Parallel Group Study to Evaluate the Pharmacokinetics and Safety of LCI699 in Subjects With Varying Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Keywords: Renal impairment, osilodrostat, LCI699
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-03-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Pharmacokinetics (PK in plasma) of a single dose of 30 mg osilodrostat: AUClast
timeFrame: 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
measure: Pharmacokinetics (PK in plasma) of a single dose of 30 mg osilodrostat: AUCinf
timeFrame: 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
measure: Pharmacokinetics (PK in plasma) of a single dose of 30 mg osilodrostat: Cmax
timeFrame: 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
measure: Pharmacokinetics (PK in urine) of a single dose of 30 mg osilodrostat: CL/F
timeFrame: 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 outcomes:
measure: The relationship between PK parameters (, T1/2, V2/F and urine AeOt)
timeFrame: 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
measure: Number of participants with adverse events
timeFrame: Pre-treatment, during treatment (Day1) and 30 days post treatment
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: