Phase 1
Completed N=32
A Study of Evacetrapib (LY2484595) in Participants With Hepatic (Liver) Impairment
Hepatic Insufficiency
Source: ClinicalTrials.gov NCT01836185 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC0-tlast) of Evacetrapib — 10700; 10500; 13200; 15800 nanograms*hour per milliliter (ng*h/mL)
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC0-tlast) of Evacetrapib |
10700; 10500; 13200; 15800 | — |
| PRIMARY PK: Maximum Observed Concentration (Cmax) of Evacetrapib |
605; 609; 591; 478 | — |
| PRIMARY PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib |
3; 3; 3; 3 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01836185). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.