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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT02399202

Collaborator

(none)

Enrollment

Locations

Arm

4.5

Actual Duration (Months)

7.5

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Renal Impairment	Drug: osilodrostat	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 6, 2015

Actual Primary Completion Date :

Mar 21, 2016

Actual Study Completion Date :

Mar 21, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: osilodrostat ( LCI699) 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	Drug: osilodrostat

Arm

Intervention/Treatment

Experimental: osilodrostat ( LCI699)

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

Drug: osilodrostat

Outcome Measures

Primary Outcome Measures

Pharmacokinetics (PK in plasma) of a single dose of 30 mg osilodrostat: AUClast [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]
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.
Pharmacokinetics (PK in plasma) of a single dose of 30 mg osilodrostat: AUCinf [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]
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.
Pharmacokinetics (PK in plasma) of a single dose of 30 mg osilodrostat: Cmax [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]
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.
Pharmacokinetics (PK in urine) of a single dose of 30 mg osilodrostat: CL/F [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]
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.

Secondary Outcome Measures

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]
Number of participants with adverse events [Pre-treatment, during treatment (Day1) and 30 days post treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Sofia		Bulgaria	1612
2	Novartis Investigative Site	Berlin		Germany	14050

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

Novartis Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT02399202

Other Study ID Numbers:

CLCI699C2104
2014-003528-35

First Posted:

Mar 26, 2015

Last Update Posted:

Dec 19, 2020

Last Verified:

Jul 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Novartis Pharmaceuticals

Renal impairment, osilodrostat, LCI699

Additional relevant MeSH terms:

Renal Insufficiency

Study Results

No Results Posted as of Dec 19, 2020