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

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ClinicalTrials.gov Identifier: NCT02399202
Recruitment Status : Completed
First Posted : March 26, 2015
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
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 : November 6, 2015
Actual Primary Completion Date : March 21, 2016
Actual Study Completion Date : March 21, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests

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



Primary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.

  3. 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 ]
    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.

  4. 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 ]
    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 :
  1. 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 ]
  2. Number of participants with adverse events [ Time Frame: Pre-treatment, during treatment (Day1) and 30 days post treatment ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02399202


Locations
Bulgaria
Novartis Investigative Site
Sofia, Bulgaria, 1612
Germany
Novartis Investigative Site
Berlin, Germany, 14050
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02399202     History of Changes
Other Study ID Numbers: CLCI699C2104
2014-003528-35 ( EudraCT Number )
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Renal impairment, osilodrostat, LCI699

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases