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A Study of LY3314814 in Participants With Liver Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03499041
Recruitment Status : Withdrawn (Stopped for futility. Phase 3 studies not likely to meet primary endpoints.)
First Posted : April 17, 2018
Last Update Posted : June 28, 2018
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatic Impairment Drug: LY3314814 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pharmacokinetics of LY3314814 in Subjects With Hepatic Impairment
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3314814 Control
LY3314814 administered orally to participants with normal hepatic function
 Drug: LY3314814
Administered orally
Experimental: LY3314814 Mild
LY3314814 administered orally to participants with mild hepatic impairment
 Drug: LY3314814
Administered orally
Experimental: LY3314814 Moderate
LY3314814 administered orally to participants with moderate hepatic impairment
 Drug: LY3314814
Administered orally
Experimental: LY3314814 Severe
LY3314814 administered orally to participants with severe hepatic impairment
 Drug: LY3314814
Administered orally


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of LY3314814 [ Time Frame: Baseline through 240 hours after the administration of study drug ]
    PK: AUC(0-∞) of LY3314814

  2. PK: Maximum Observed Drug Concentration (Cmax) of LY3314814 [ Time Frame: Baseline through 240 hours after the administration of study drug ]
    PK: Cmax of LY3314814


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499041


Locations
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United States, California
Orange County Research Center
Tustin, California, United States, 92780
United States, Florida
Clinical Pharmacology of Miami
Miami, Florida, United States, 33014
Orlando Clinical Research Ctr
Orlando, Florida, United States, 32809
United States, Tennessee
New Orleans Cntr for Clin Res
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
Eli Lilly and Company
AstraZeneca
Investigators
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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
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03499041    
Other Study ID Numbers: 16003
I8D-MC-AZEJ ( Other Identifier: Eli Lilly and Company )
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases