Conditions: Healthy Volunteers
Keywords: Healthy Volunteers Bioavailability
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 35
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: A 20 milligram (mg) LY2409021 dose, reference form administered orally in the fasted state arm 2: Single 20 mg LY2409021 test form with medium particle size administered orally immediately after ingestion of a standardized high-fat meal arm 3: Single 20 mg LY2409021 test form with medium particle size administered orally in the fasted state arm 4: Single 20 mg LY2409021 test form with low particle size administered orally in the fasted state arm 5: Single 20 mg LY2409021 test form with medium particle size administered orally in the fasted state arm 6: Single 20 mg LY2409021 test form with high particle size administered orally in the fasted state

Interventions: intervention 1: LY2409021 Reference Form intervention 2: LY2409021 Test-Med Formulation (medium particle size) intervention 3: LY2409021 Test-High Formulation (high particle size) intervention 4: LY2409021 Test-Low Formulation (low particle size)
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally intervention 4: Administered orally

Protocol document: