NCT02399202

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_1

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

November 6, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2016

Completed
Last Updated

December 19, 2020

Status Verified

July 1, 2017

Enrollment Period

5 months

First QC Date

March 20, 2015

Last Update Submit

December 16, 2020

Conditions

Renal Impairment

Keywords

Renal impairment, osilodrostat, LCI699

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • 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

Study Arms (1)

osilodrostat ( LCI699)

EXPERIMENTAL

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

Interventions

osilodrostatDRUG
osilodrostat ( LCI699)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novartis Investigative Site

Sofia, 1612, Bulgaria

Location

Novartis Investigative Site

Berlin, 14050, Germany

Location

Related Links

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Osilodrostat

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2015

First Posted

March 26, 2015

Study Start

November 6, 2015

Primary Completion

March 21, 2016

Study Completion

March 21, 2016

Last Updated

December 19, 2020

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

BU(1)DE(1)