Back to resultsA Study of LY3314814 in Participants With Liver Impairment
Primary Purpose
Hepatic Impairment
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY3314814
Sponsored by
About this trial
This is an interventional basic science trial for Hepatic Impairment
Eligibility Criteria
Inclusion Criteria:
- Have a Body Mass Index (BMI) of 18 to 40 kilogram per meter square (kg/m²), inclusive, at the time of screening
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
- New Orleans Cntr for Clin Res
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
LY3314814 Control
LY3314814 Mild
LY3314814 Moderate
LY3314814 Severe
Arm Description
LY3314814 administered orally to participants with normal hepatic function
LY3314814 administered orally to participants with mild hepatic impairment
LY3314814 administered orally to participants with moderate hepatic impairment
LY3314814 administered orally to participants with severe hepatic impairment
Outcomes
Primary Outcome Measures
Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of LY3314814
PK: AUC(0-∞) of LY3314814
PK: Maximum Observed Drug Concentration (Cmax) of LY3314814
PK: Cmax of LY3314814
Secondary Outcome Measures
Full Information
NCT ID
NCT03499041
First Posted
April 9, 2018
Last Updated
June 26, 2018
Sponsor
Eli Lilly and Company
Collaborators
AstraZeneca
1. Study Identification
Unique Protocol Identification Number
NCT03499041
Brief Title
A Study of LY3314814 in Participants With Liver Impairment
Official Title
Pharmacokinetics of LY3314814 in Subjects With Hepatic Impairment
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Withdrawn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
December 2018 (Anticipated)
Study Completion Date
December 2018 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Impairment
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
LY3314814 Control
Arm Type
Experimental
Arm Description
LY3314814 administered orally to participants with normal hepatic function
Arm Title
LY3314814 Mild
Arm Type
Experimental
Arm Description
LY3314814 administered orally to participants with mild hepatic impairment
Arm Title
LY3314814 Moderate
Arm Type
Experimental
Arm Description
LY3314814 administered orally to participants with moderate hepatic impairment
Arm Title
LY3314814 Severe
Arm Type
Experimental
Arm Description
LY3314814 administered orally to participants with severe hepatic impairment
Intervention Type
Drug
Intervention Name(s)
LY3314814
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of LY3314814
Description
PK: AUC(0-∞) of LY3314814
Time Frame
Baseline through 240 hours after the administration of study drug
Title
PK: Maximum Observed Drug Concentration (Cmax) of LY3314814
Description
PK: Cmax of LY3314814
Time Frame
Baseline through 240 hours after the administration of study drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- Have a Body Mass Index (BMI) of 18 to 40 kilogram per meter square (kg/m²), inclusive, at the time of screening
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
Facility Name
New Orleans Cntr for Clin Res
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of LY3314814 in Participants With Liver Impairment
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