Study Stopped
Stopped for futility. Phase 3 studies not likely to meet primary endpoints.
A Study of Lanabecestat in Participants With Severe Kidney Impairment Compared to Healthy Participants
Pharmacokinetics of Lanabecestat (LY3314814) in Subjects With Impaired Renal Function
2 other identifiers
interventional
N/A
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2018
Shorter than P25 for phase_1
3 active sites
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
May 22, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedFirst Posted
Study publicly available on registry
June 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedJune 28, 2018
June 1, 2018
7 months
May 22, 2018
June 26, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Pharmacokinetics (PK): Area Under The Concentration Versus Time Curve From Zero To Infinity (AUC[0-∞]) for Lanabecestat
PK: AUC(0-∞) for Lanabecestat
Baseline through 168 hours after the administration of study drug
PK: Maximum Observed Drug Concentration (Cmax) of Lanabecestat
PK: Cmax of Lanabecestat
Baseline through 168 hours after the administration of study drug
Study Arms (2)
Lanabecestat Control
EXPERIMENTALLanabecestat administered orally to participants with normal renal function
Lanabecestat Severe Renal Impairment
EXPERIMENTALLanabecestat administered orally to participants with severe renal impairment, not on dialysis
Interventions
Administered orally
Administered intravenously. Administration is at investigator's discretion in participants with severe renal impairment.
Eligibility Criteria
You may qualify if:
- \- Have a body mass index (BMI) of 19 to 40 kilograms per meter square (kg/m²)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- AstraZenecacollaborator
Study Sites (3)
Orange County Research Center
Tustin, California, 92780, United States
Clinical Pharmacology of Miami
Miami, Florida, 33014, United States
Orlando Clinical Research Ctr.
Orlando, Florida, 32809, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2018
First Posted
June 4, 2018
Study Start
June 1, 2018
Primary Completion
January 1, 2019
Study Completion
January 1, 2019
Last Updated
June 28, 2018
Record last verified: 2018-06