A Study of Evacetrapib (LY2484595) in Participants With Hepatic (Liver) Impairment

Lilly

Status and phase: Completed; Phase 1

Conditions: Hepatic Insufficiency

Treatments: Drug: Evacetrapib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01836185

14621

I1V-MC-EIAS (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to measure how much of the drug gets into the bloodstream and how long it takes the body to remove it when given to participants with hepatic (liver) impairment compared to participants with normal hepatic function. Information about any side effects that may occur will also be collected. This study will last approximately 28 days, not including screening.

Enrollment: 32 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants have given written informed consent approved by the ethical review board (ERB) governing the site
• Female participants should be of non-childbearing potential
• Have a body mass index (BMI) of 18 to 40 kilograms per square meter (kg/m^2)
• Healthy participants have normal hepatic function as determined by medical history, physical examination, and other screening procedures
• Individuals with hepatic impairment classified as Child-Pugh score A, B, or C (mild, moderate, or severe impairment)

Exclusion criteria

• Has had esophagus variceal bleeding within 3 months of check-in
• Have the need to take medications that may interfere with how the liver removes the drug
• Have evidence of cancer in the liver
• Consumes excessively large amounts of drinks with caffeine or alcohol

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

Evacetrapib (Healthy)

Experimental group

Description:

Group 1: 130 milligrams (mg) evacetrapib administered once, orally, to participants with normal hepatic function

Treatment:

Drug: Evacetrapib

Evacetrapib (Hepatic, Mild)

Experimental group

Description:

Group 2: 130 mg evacetrapib administered once, orally, to participants with mild hepatic impairment

Treatment:

Drug: Evacetrapib

Evacetrapib (Hepatic, Moderate)

Experimental group

Description:

Group 3: 130 mg evacetrapib administered once, orally, to participants with moderate hepatic impairment

Treatment:

Drug: Evacetrapib

Evacetrapib (Hepatic, Severe)

Experimental group

Description:

Group 4: 130 mg evacetrapib administered once, orally, to participants with severe hepatic impairment

Treatment:

Drug: Evacetrapib