A Phase I Study of Osilodrostat (LCI699) in Healthy Volunteers and Subjects With Impaired Renal Function

Novartis Pharmaceuticals15 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Impairment

Interventions

osilodrostatDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Novartis Investigative Site

Sofia, Bulgaria

Novartis Investigative Site

Berlin, Germany

Outcomes

Primary Outcomes

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.