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NCT03499041 Clinical Trial

A Study of LY3314814 in Participants With Liver Impairment

Hepatic Impairment Clinical Trial

Official title:
Pharmacokinetics of LY3314814 in Subjects With Hepatic Impairment

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03499041
Other study ID # 16003
Secondary ID I8D-MC-AZEJ
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date June 2018
Est. completion date December 2018

Study information
Verified date June 2018
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• LY3314814
Administered orally

Locations
Country Name City State
United States New Orleans Cntr for Clin Res Knoxville Tennessee
United States Clinical Pharmacology of Miami Miami Florida
United States Orlando Clinical Research Ctr Orlando Florida
United States Orange County Research Center Tustin California

Sponsors (2)
Lead Sponsor Collaborator
Eli Lilly and Company AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-8]) of LY3314814 PK: AUC(0-8) of LY3314814 Baseline through 240 hours after the administration of study drug
Primary PK: Maximum Observed Drug Concentration (Cmax) of LY3314814 PK: Cmax of LY3314814 Baseline through 240 hours after the administration of study drug
See also
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