A Study of LY3314814 in Participants With Liver Impairment

Pharmacokinetics of LY3314814 in Subjects With Hepatic Impairment

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.

Study Overview

• Status: Withdrawn
• Conditions: Hepatic Impairment
• Intervention / Treatment: Drug: LY3314814

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Tustin, California, United States, 92780
      • Orange County Research Center
  • Florida
    • Miami, Florida, United States, 33014
      • Clinical Pharmacology of Miami
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Ctr
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • New Orleans Cntr for Clin Res

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2018
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: April 9, 2018
• First Submitted That Met QC Criteria: April 13, 2018
• First Posted (Actual): April 17, 2018

Study Record Updates

• Last Update Posted (Actual): June 28, 2018
• Last Update Submitted That Met QC Criteria: June 26, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: 16003; I8D-MC-AZEJ (Other Identifier: Eli Lilly and Company)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No