drugset / Trial / NCT01836198

The Effect of Gemfibrozil, Ketoconazole and Clarithromycin on the Amount of LY2409021 in the Bloodstream

NCT01836198

Phase 1 Completed 30 enrolled Eli Lilly and Company
RandomizedParallel-groupOpen-labelBasic science

Summary

The purpose of this study is to examine the effect of gemfibrozil, ketoconazole, and clarithromycin on how much LY2409021 is found in the bloodstream and how long the body takes to get rid of it. The study is split into two parts, Part A and Part B. Participants in Part A are divided into two cohorts (groups). Each cohort will participate in two study periods. Period 1 involves a single dose of LY2409021. Period 2 involves either gemfibrozil or ketoconazole given daily for 21 days with LY2409021 given once on Day 4. Part A will last for 51 days and will also involve screening within 27 days of the start of the study. Part B is only open to participants who successfully completed Part A of the study. Participants in Part B will receive clarithromycin given daily for 21 days with LY2409021 given once on Day 4. Part B will last for 29 days and will also involve screening within 27 days of the start of the study.

Timeline

Start
2013-05
Primary completion
2013-11
Completion
2013-11

Drugs

EvaluationDrugModalityDoseRoute
Subject ADOMEGLIVANT Small molecule 20 mg Oral
Subject Clarithromycin Small molecule 500 mg Oral
Subject Gemfibrozil Small molecule 600 mg Oral
Subject Ketoconazole Small molecule 400 mg Oral

Indications

No indication recorded.