drugset / Trial / NCT01354496

A Study of LY2409021 Formulations and the Effect of Food

NCT01354496

Phase 1 Completed 35 enrolled Eli Lilly and Company
RandomizedCrossoverOpen-labelBasic science

Summary

The purposes of this study are to compare how much of LY2409021 enters the bloodstream and how long the body takes to get rid of the drug when different formulations of LY2409021 are given, and when LY2409021 is taken with or without food. The study will be conducted in 2 cohorts. Each cohort will have 3 study periods consisting of 3 formulations of LY2409021. Participants in each cohort will receive the same all 3 formulations using a randomized sequence crossover design. There is a washout period of at least 14 days between dosing periods. There will be an interim analysis after Cohort 1 completes study Period 2. Cohort 2 will not begin enrolling until this analysis is complete. The need to enroll Cohort 2 will be determined by the outcome of the interim analysis.

Timeline

Start
2011-04
Primary completion
2011-10
Completion
2011-10

Drugs

EvaluationDrugModalityDoseRoute
Subject ADOMEGLIVANT Small molecule 20 mg Oral

Indications

No indication recorded.