Clincosm LogoSign in Get a demo

A Study of Lanabecestat in Participants With Severe Kidney Impairment Compared to Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT03545087
Collaborator
AstraZeneca (Industry)
0
Enrollment
3
Locations
2
Arms
7
Anticipated Duration (Months)
0
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to determine whether lanabecestat can be safely prescribed in participants with kidney impairment without a dose adjustment.

Participants will be on study for up to 6 weeks; this includes a 2-week screening and a follow-up about 10 days after final drug administration.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Pharmacokinetics of Lanabecestat (LY3314814) in Subjects With Impaired Renal Function
Anticipated Study Start Date :
Jun 1, 2018
Anticipated Primary Completion Date :
Jan 1, 2019
Anticipated Study Completion Date :
Jan 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lanabecestat Control

Lanabecestat administered orally to participants with normal renal function

Drug: Lanabecestat
Administered orally
Other Names:
  • LY3314814

    		•
    Experimental: Lanabecestat Severe Renal Impairment

    Lanabecestat administered orally to participants with severe renal impairment, not on dialysis

    Drug: Lanabecestat
    Administered orally
    Other Names:
  • LY3314814

    • Drug: Iohexol
    Administered intravenously. Administration is at investigator's discretion in participants with severe renal impairment.

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK): Area Under The Concentration Versus Time Curve From Zero To Infinity (AUC[0-∞]) for Lanabecestat [Baseline through 168 hours after the administration of study drug]

      PK: AUC(0-∞) for Lanabecestat

    2. PK: Maximum Observed Drug Concentration (Cmax) of Lanabecestat [Baseline through 168 hours after the administration of study drug]

      PK: Cmax of Lanabecestat

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Have a body mass index (BMI) of 19 to 40 kilograms per meter square (kg/m²)
    Exclusion Criteria:

    • Have a history of or current significant ophthalmic disease, particularly any eye problem involving the retina

    • Have moderate or severe vitiligo or any other clinically significant disorder of skin or hair pigmentation

    • Have acute unstable neuropsychiatric disease

    • Have active or uncontrolled neurologic disease, or clinically significant head injury

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Orange County Research Center Tustin California United States 92780
    2 Clinical Pharmacology of Miami Miami Florida United States 33014
    3 Orlando Clinical Research Ctr. Orlando Florida United States 32809

    Sponsors and Collaborators

    • Eli Lilly and Company
    • AstraZeneca

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT03545087
    Other Study ID Numbers:
    • 16007
    • I8D-MC-AZEN
    First Posted:
    Jun 4, 2018
    Last Update Posted:
    Jun 28, 2018
    Last Verified:
    Jun 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Renal Insufficiency

    Study Results

    No Results Posted as of Jun 28, 2018