A Study of LY2409021 Formulations in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to measure how much of the new LY2409021 tablet formulations get into the blood stream and how long it takes the body to get rid of them, compared to the current LY2409021 capsule formulation. In addition, the safety and tolerability of both the new and current formulations will be evaluated. Information about any side effects that may occur will also be collected. The study has two parts. Each participant may enroll in one part only. The study will last up to 8 weeks for each participant. Screening is required prior to the start of the study.

Official Title
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A Single Dose Pharmacokinetic Study of LY2409021 in Healthy Subjects to Bridge Formulations From Capsules to Commercial Tablets

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY2409021


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overtly healthy males or surgically sterile or postmenopausal females, as determined by medical history and physical examination Have a body mass index (BMI) of 18.0 to 32.0 kilogram per square meter (kg/m^2) Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator Exclusion Criteria: Have known allergies to LY2409021, related compounds or any components of the formulation, or history of significant atopy Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study Have known or ongoing psychiatric disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A: LY2409021 Capsule<br>Single oral dose of LY2409021 capsule in one of three study periods. | Drug: LY2409021<br>* Administered orally<br>|
| Experimental: Part A: LY2409021 Tablet Pre-commercial<br>Single oral dose of LY2409021 tablet (pre-commercial formulation) in one of three study periods. | Drug: LY2409021<br>* Administered orally<br>|
| Experimental: Part A: LY2409021 Tablet Commercial<br>Single oral dose of LY2409021 tablet (commercial formulation) in one of three study periods. | Drug: LY2409021<br>* Administered orally<br>|
| Experimental: Part B: LY2409021 Capsule<br>Single oral dose of LY2409021 capsule in one of two study periods. | Drug: LY2409021<br>* Administered orally<br>|
| Experimental: Part B: LY2409021 Tablet Commercial<br>Single oral dose of LY2409021 tablet (commercial formulation) in one of two study periods. | Drug: LY2409021<br>* Administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2409021 |  | Day 1: Predose, 0.5 Hours (H), 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each Period | 
| PK: Maximum Plasma Concentration (Cmax) of LY2409021 |  | Day 1: Predose, 0.5 H, 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each Period |