A Study of LY2775240 in Healthy Participants

Study Overview
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Brief Summary
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This study is conducted to determine the side effects related to LY2775240 given orally to healthy participants. Blood tests will be done to check how much LY2775240 is absorbed into the bloodstream and how long the body takes to get rid of it. Each participant will enroll in either Part A or Part B of the study, which will last about 14 weeks and 8 weeks respectively, including screening.

Official Title
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A 2-Part, Safety, Tolerability, and Pharmacokinetic Study of LY2775240 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY2775240
* Drug: Placebo
* Drug: Apremilast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overtly healthy adult male or a female who cannot get pregnant Have a screening body mass index (BMI) of greater than 18 and less than or equal to 32 kilograms per meter square (kg/m²), inclusive Have normal blood pressure, pulse rate, electrocardiogram (ECG) and medical test results that are acceptable for the study Exclusion Criteria: Are currently participating in or completed a clinical trial within the last 30 days from a clinical trial or any other type of medical research judged to be incompatible with this study Have known allergies to compounds or drugs similar to LY2775240 or apremilast Have previously participated or withdrawn from this study Have or used to have health problems or medical test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY2775240 (Part A)<br>Escalating oral doses of LY2775240 administered in healthy participants | Drug: LY2775240<br>* Administered orally<br>|
| Experimental: LY2775240 (Part B)<br>Oral dose of LY2775240 in healthy participants | Drug: LY2775240<br>* Administered orally<br>|
| Placebo Comparator: Placebo (Part A)<br>Placebo administered orally in healthy participants | Drug: Placebo<br>* Administered orally<br>|
| Active Comparator: Apremilast (Part B)<br>Oral dose of apremilast in healthy participants | Drug: Apremilast<br>* Administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |  | Baseline through to final follow-up at approximately Week 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2775240 |  | Baseline through Day 5 | 
| Pharmacokinetics: Time to Maximal Blood Concentration of LY2775240 |  | Baseline through Day 5 | 
| Pharmacokinetics: Maximum Concentration of LY2775240 in Blood |  | Baseline through Day 5 |