A Study of LY3314814 in Participants With Liver Impairment

Lilly

Status and phase: Withdrawn; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: LY3314814

Study type: Interventional

Funder types: Industry

Identifiers

NCT03499041

I8D-MC-AZEJ (Other Identifier)

16003

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 4 patient groups

LY3314814 Control

Experimental group

Description:

LY3314814 administered orally to participants with normal hepatic function

Treatment:

Drug: LY3314814

LY3314814 Mild

Experimental group

Description:

LY3314814 administered orally to participants with mild hepatic impairment

Treatment:

Drug: LY3314814

LY3314814 Moderate

Experimental group

Description:

LY3314814 administered orally to participants with moderate hepatic impairment

Treatment:

Drug: LY3314814

LY3314814 Severe

Experimental group

Description:

LY3314814 administered orally to participants with severe hepatic impairment

Treatment:

Drug: LY3314814