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A Study of LY3314814 in Participants With Liver Impairment

Pharmacokinetics of LY3314814 in Subjects With Hepatic Impairment

Status
Withdrawn
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03499041
Enrollment
0
Registered
2018-04-17
Start date
2018-06-30
Completion date
2018-12-31
Last updated
2018-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Impairment

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.

Interventions

Administered orally

Sponsors

AstraZeneca
CollaboratorINDUSTRY
Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of LY3314814Baseline through 240 hours after the administration of study drugPK: AUC(0-∞) of LY3314814
PK: Maximum Observed Drug Concentration (Cmax) of LY3314814Baseline through 240 hours after the administration of study drugPK: Cmax of LY3314814

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026