A Study of LY3314814 in Participants With Liver Impairment

Phase 1

Withdrawn

• Conditions: Hepatic Impairment
• Interventions: Drug: LY3314814

• Registration Number: NCT03499041
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-09
• Study First Submitted QC: 2018-04-13
• Study First Posted: 2018-04-17
• Status Verified: 2018-06
• Study Start: 2018-06
• Last Update Submitted: 2018-06-26
• Last Update Posted: 2018-06-28
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Have a Body Mass Index (BMI) of 18 to 40 kilogram per meter square (kg/m²), inclusive, at the time of screening

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3314814 Control	LY3314814	LY3314814 administered orally to participants with normal hepatic function
LY3314814 Mild	LY3314814	LY3314814 administered orally to participants with mild hepatic impairment
LY3314814 Moderate	LY3314814	LY3314814 administered orally to participants with moderate hepatic impairment
LY3314814 Severe	LY3314814	LY3314814 administered orally to participants with severe hepatic impairment

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of LY3314814	Baseline through 240 hours after the administration of study drug	PK: AUC(0-∞) of LY3314814
PK: Maximum Observed Drug Concentration (Cmax) of LY3314814	Baseline through 240 hours after the administration of study drug	PK: Cmax of LY3314814

Trial Locations

Locations (4)

New Orleans Cntr for Clin Res; 🇺🇸 Knoxville, Tennessee, United States

Orange County Research Center; 🇺🇸 Tustin, California, United States

Clinical Pharmacology of Miami; 🇺🇸 Miami, Florida, United States

Orlando Clinical Research Ctr; 🇺🇸 Orlando, Florida, United States