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

Novartis

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: osilodrostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT02399202

CLCI699C2104

2014-003528-35 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

osilodrostat ( LCI699)

Experimental group

Description:

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

Treatment:

Drug: osilodrostat