A Study of LY3202626 in Healthy Participants

Study Overview
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Brief Summary
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The purposes of this study are to determine: If there are any differences in the way LY3202626 is handled by the body when taken in two different forms Whether a high fat meal affects the way the body handles LY3202626 How well tolerated LY3202626 is There are three (3) study periods for all participants. Participants will be admitted to the clinical research unit (CRU) each period and will be discharged from the CRU following the completion of 2 overnight stays and up to 36 hours after dosing with LY3202626. The study will last about 50 days, not including screening.

Official Title
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Relative Bioavailability and Food Effect Study in Healthy Subjects Administered Two Different Formulations of LY3202626

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3202626 (R-Fasting)
* Drug: LY3202626 (T1-Fasting)
* Drug: LY3202626 (T1-Fed)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are overtly healthy males or females, as determined by medical history and physical examination Female participants must be of non-childbearing potential confirmed by medical history or menopause Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive, at screening Exclusion Criteria: Are investigative site personnel directly affiliated with this study and their immediate families Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed Have previously completed or withdrawn from this study or any other study investigating LY3202626, and have previously received the investigational product Have a history of or current 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 investigational product; or of interfering with the interpretation of data Have a history of head trauma with loss of consciousness within the last 5 years Have known or ongoing psychiatric disorders

Ages Eligible for Study
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Minimum Age: 21 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: LY3202626 (R-Fasting)<br>Single oral dose of LY3202626 (R) capsule under fasting conditions. | Drug: LY3202626 (R-Fasting)<br>* Administered orally<br>|
| Experimental: LY3202626 (T1-Fasting)<br>Single oral dose of LY3202626 (T1) tablet under fasting conditions. | Drug: LY3202626 (T1-Fasting)<br>* Administered orally<br>|
| Experimental: LY3202626 (T1-Fed)<br>Single oral dose of LY3202626 (T1) following a high fat breakfast. | Drug: LY3202626 (T1-Fed)<br>* Administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3202626 | Pharmacokinetics (PK) is the maximum observed drug concentration (Cmax) of LY3202626 | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose | 
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3202626 | PK is the area under the concentration versus time curve from time zero to infinity (AUC[0-∞]) of LY3202626 | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose | 
| PK: AUC From Time Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3202626 | PK is the AUC from time zero to time t, where t is the last time point with a measurable concentration (AUC[0-tlast]) of LY3202626 | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose |