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

Renal Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02399202
• Other study ID #: CLCI699C2104
• Secondary ID: 2014-003528-35
• Status: Completed
• Phase: Phase 1
• Start date: November 6, 2015
• Est. completion date: March 21, 2016

Study information

• Verified date: July 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 21, 2016
• Est. primary completion date: March 21, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• osilodrostat

Locations

Country	Name	City	State
Bulgaria	Novartis Investigative Site	Sofia
Germany	Novartis Investigative Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Bulgaria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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
Primary	Pharmacokinetics (PK in plasma) of a single dose of 30 mg osilodrostat: AUCinf	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.	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
Primary	Pharmacokinetics (PK in plasma) of a single dose of 30 mg osilodrostat: Cmax	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.	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
Primary	Pharmacokinetics (PK in urine) of a single dose of 30 mg osilodrostat: CL/F	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.	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	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
Secondary	Number of participants with adverse events		Pre-treatment, during treatment (Day1) and 30 days post treatment

External Links

•   Results for CLCI699C2104 can be found on the Novartis Clinical Trial Results Website