Study Stopped
Stopped for futility. Phase 3 studies not likely to meet primary endpoints.
A Study of LY3314814 in Participants With Liver Impairment
Pharmacokinetics of LY3314814 in Subjects With Hepatic Impairment
2 other identifiers
interventional
N/A
1 country
4
Brief Summary
The purpose of the study is to determine whether LY3314814 can be safely prescribed in participants with liver impairment without a dose adjustment. Participants will be on study for 11 days with follow-up about 7 days afterward.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2018
Shorter than P25 for phase_1
4 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
April 9, 2018
CompletedFirst Posted
Study publicly available on registry
April 17, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJune 28, 2018
June 1, 2018
6 months
April 9, 2018
June 26, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of LY3314814
PK: AUC(0-∞) of LY3314814
Baseline through 240 hours after the administration of study drug
PK: Maximum Observed Drug Concentration (Cmax) of LY3314814
PK: Cmax of LY3314814
Baseline through 240 hours after the administration of study drug
Study Arms (4)
LY3314814 Control
EXPERIMENTALLY3314814 administered orally to participants with normal hepatic function
LY3314814 Mild
EXPERIMENTALLY3314814 administered orally to participants with mild hepatic impairment
LY3314814 Moderate
EXPERIMENTALLY3314814 administered orally to participants with moderate hepatic impairment
LY3314814 Severe
EXPERIMENTALLY3314814 administered orally to participants with severe hepatic impairment
Interventions
Eligibility Criteria
You may qualify if:
- \- Have a Body Mass Index (BMI) of 18 to 40 kilogram per meter square (kg/m²), inclusive, at the time of screening
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 (4)
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
New Orleans Cntr for Clin Res
Knoxville, Tennessee, 37920, United States
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
April 9, 2018
First Posted
April 17, 2018
Study Start
June 1, 2018
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
June 28, 2018
Record last verified: 2018-06