Phase 1
Completed N=20
A Study of Evacetrapib (LY2484595) in Participants With Severe Renal Impairment and in Healthy Participants
Source: ClinicalTrials.gov NCT01825889 ↗Enrolled (actual)
20
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, Where Tlast is the Last Time Point With a Measurable Concentration (AUC[0-Tlast]) of Evacetrapib — 15200; 16000 nanograms*hours/milliliter (ng*h/mL)
Summary
The purpose of this study is to measure how much of the study drug, evacetrapib, enters the blood stream and how long it takes the body to dispose of the study drug when given to participants with severe renal (kidney) impairment compared to participants with normal renal (kidney) function. This study will last approximately 8 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Area Under The Concentration Versus Time Curve From Time Zero To Time Tlast, Where Tlast is the Last Time Point With a Measurable Concentration (AUC[0-Tlast]) of Evacetrapib |
15200; 16000 | — |
| PRIMARY Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-∞]) of Evacetrapib |
15500; 16300 | — |
| SECONDARY Pharmacokinetics (PK): Observed Maximum Concentration (Cmax) of Evacetrapib |
969; 1140 | — |
Eligibility Criteria
Inclusion Criteria
- Female participants are not of child-bearing potential
- Have a body mass index of 18 to 40 kilograms per square meter (kg/m^2)
- Participants with normal renal function - healthy as determined by medical history, physical examination, and other screening procedures, with normal renal function (assessed by estimated creatinine clearance [CLcr] greater than or equal to 90 milliliters per minute [mL/min] at screening)
- Participants with severe renal impairment - estimated CLcr less than 30 mL/min at screening and are not undergoing hemodialysis
Exclusion Criteria
- Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
- Participants who are unwilling to comply with the dietary requirements/restrictions during the study
- Hemoglobin less than 9 grams/deciliter (g/dL) or significant active hematological disease from causes other than underlying renal disease
Data sourced from ClinicalTrials.gov (NCT01825889). 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.