A Study of LY3314814 in Participants With Liver Impairment

NCT ID: NCT03499041

Last Updated: 2018-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-30

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LY3314814 Control

LY3314814 administered orally to participants with normal hepatic function

Group Type EXPERIMENTAL

LY3314814

Intervention Type DRUG

Administered orally

LY3314814 Mild

LY3314814 administered orally to participants with mild hepatic impairment

Group Type EXPERIMENTAL

LY3314814

Intervention Type DRUG

Administered orally

LY3314814 Moderate

LY3314814 administered orally to participants with moderate hepatic impairment

Group Type EXPERIMENTAL

LY3314814

Intervention Type DRUG

Administered orally

LY3314814 Severe

LY3314814 administered orally to participants with severe hepatic impairment

Group Type EXPERIMENTAL

LY3314814

Intervention Type DRUG

Administered orally

Interventions

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LY3314814

Administered orally

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Orange County Research Center

Tustin, California, United States

Site Status

Clinical Pharmacology of Miami

Miami, Florida, United States

Site Status

Orlando Clinical Research Ctr

Orlando, Florida, United States

Site Status

New Orleans Cntr for Clin Res

Knoxville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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I8D-MC-AZEJ

Identifier Type: OTHER

Identifier Source: secondary_id

16003

Identifier Type: -

Identifier Source: org_study_id

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