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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02399202
• Date of registration: 20/03/2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: A Phase I Study of Osilodrostat (LCI699) in Healthy Volunteers and Subjects With Impaired Renal Function
• Scientific 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
• Date of first enrolment: November 6, 2015
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02399202
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Bulgaria, Germany, Romania, South Africa

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Renal Impairment

Intervention(s)

Drug: osilodrostat

Primary Outcome(s)

Pharmacokinetics (PK in plasma) of a single dose of 30 mg osilodrostat: Cmax [Time Frame: 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]

Pharmacokinetics (PK in urine) of a single dose of 30 mg osilodrostat: CL/F [Time Frame: 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]

Pharmacokinetics (PK in plasma) of a single dose of 30 mg osilodrostat: AUClast [Time Frame: 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]

Pharmacokinetics (PK in plasma) of a single dose of 30 mg osilodrostat: AUCinf [Time Frame: 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 Outcome(s)

The relationship between PK parameters (, T1/2, V2/F and urine AeOt) [Time Frame: 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 [Time Frame: Pre-treatment, during treatment (Day1) and 30 days post treatment]

Secondary ID(s)

2014-003528-35

CLCI699C2104

Source(s) of Monetary Support

Please refer to primary and secondary sponsors