Back to resultsA Study of Lanabecestat in Participants With Severe Kidney Impairment Compared to Healthy Participants
Primary Purpose
Renal Insufficiency
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lanabecestat
Iohexol
Sponsored by
About this trial
This is an interventional basic science trial for Renal Insufficiency
Eligibility Criteria
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
Sites / Locations
- Orange County Research Center
- Clinical Pharmacology of Miami
- Orlando Clinical Research Ctr.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Lanabecestat Control
Lanabecestat Severe Renal Impairment
Arm Description
Lanabecestat administered orally to participants with normal renal function
Lanabecestat administered orally to participants with severe renal impairment, not on dialysis
Outcomes
Primary Outcome Measures
Pharmacokinetics (PK): Area Under The Concentration Versus Time Curve From Zero To Infinity (AUC[0-∞]) for Lanabecestat
PK: AUC(0-∞) for Lanabecestat
PK: Maximum Observed Drug Concentration (Cmax) of Lanabecestat
PK: Cmax of Lanabecestat
Secondary Outcome Measures
Full Information
NCT ID
NCT03545087
First Posted
May 22, 2018
Last Updated
June 26, 2018
Sponsor
Eli Lilly and Company
Collaborators
AstraZeneca
1. Study Identification
Unique Protocol Identification Number
NCT03545087
Brief Title
A Study of Lanabecestat in Participants With Severe Kidney Impairment Compared to Healthy Participants
Official Title
Pharmacokinetics of Lanabecestat (LY3314814) in Subjects With Impaired Renal Function
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Stopped for futility. Phase 3 studies not likely to meet primary endpoints.
Study Start Date
June 2018 (Anticipated)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
Collaborators
AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lanabecestat Control
Arm Type
Experimental
Arm Description
Lanabecestat administered orally to participants with normal renal function
Arm Title
Lanabecestat Severe Renal Impairment
Arm Type
Experimental
Arm Description
Lanabecestat administered orally to participants with severe renal impairment, not on dialysis
Intervention Type
Drug
Intervention Name(s)
Lanabecestat
Other Intervention Name(s)
LY3314814
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Iohexol
Intervention Description
Administered intravenously. Administration is at investigator's discretion in participants with severe renal impairment.
Primary Outcome Measure Information:
Title
Pharmacokinetics (PK): Area Under The Concentration Versus Time Curve From Zero To Infinity (AUC[0-∞]) for Lanabecestat
Description
PK: AUC(0-∞) for Lanabecestat
Time Frame
Baseline through 168 hours after the administration of study drug
Title
PK: Maximum Observed Drug Concentration (Cmax) of Lanabecestat
Description
PK: Cmax of Lanabecestat
Time Frame
Baseline through 168 hours after the administration of study drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Clinical Pharmacology of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Orlando Clinical Research Ctr.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Lanabecestat in Participants With Severe Kidney Impairment Compared to Healthy Participants
We'll reach out to this number within 24 hrs