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

Primary Purpose

Renal Impairment

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

osilodrostat

About this trial

This is an interventional treatment trial for Renal Impairment focused on measuring Renal impairment, osilodrostat, LCI699

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

Novartis Investigative Site
Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

osilodrostat ( LCI699)

Arm 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

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

Secondary Outcome Measures

The relationship between PK parameters (, T1/2, V2/F and urine AeOt)

Number of participants with adverse events

Full Information

NCT ID

NCT02399202

First Posted

March 20, 2015

Last Updated

December 16, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02399202

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

November 6, 2015 (Actual)

Primary Completion Date

March 21, 2016 (Actual)

Study Completion Date

March 21, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Impairment

Keywords

Renal impairment, osilodrostat, LCI699

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

osilodrostat ( LCI699)

Arm Type

Experimental

Arm 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

Intervention Type

Drug

Intervention Name(s)

osilodrostat

Primary Outcome Measure Information:

Title

Pharmacokinetics (PK in plasma) of a single dose of 30 mg osilodrostat: AUClast

Description

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.

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

Title

Pharmacokinetics (PK in plasma) of a single dose of 30 mg osilodrostat: AUCinf

Description

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.

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

Title

Pharmacokinetics (PK in plasma) of a single dose of 30 mg osilodrostat: Cmax

Description

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.

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

Title

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

Description

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.

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 Measure Information:

Title

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

Title

Number of participants with adverse events

Time Frame

Pre-treatment, during treatment (Day1) and 30 days post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1612

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

14050

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=16047

Description

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

Learn more about this trial

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

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