A Study of LY2409021 Formulations and the Effect of Food

Phase 1

Completed

Interventions: Drug: LY2409021 Test-Med Formulation (medium particle size)
Drug: LY2409021 Reference Form
Drug: LY2409021 Test-High Formulation (high particle size)
Drug: LY2409021 Test-Low Formulation (low particle size)

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.

Recruitment & Eligibility

Inclusion Criteria

Must be healthy male or a healthy female who cannot become pregnant
Must have body mass index (BMI) of 18.5 to 32 kilograms per meter squared (kg/m²), inclusive
Blood pressure as well as blood and urine laboratory test results must be acceptable for the study
The veins must be suitable for easy blood collection
Must be willing to be available for the whole study and be willing to follow study procedures

Exclusion Criteria

Were in another new drug or medical research study in the last 30 days
Have previously taken part in this study or any other study with LY2409021
Have taken LY2409021, or drugs similar to LY2409021 before and was found to be allergic to the drug
Currently have or used to have health problems or laboratory test results that in the opinion of the doctor, could interfere with understanding the results of this study
Electrocardiogram (ECG) readings are not suitable for the study
Are infected with hepatitis B
Are infected with human immunodeficiency disease virus (HIV)
Are using or intend to use over-the-counter medication or prescription medications within 14 days, from the start of the first study dosing until end of study
Have a regular alcohol intake greater than 21 units per week (males) and 14 units per week (females) or are not willing to abstain from alcohol while in the research unit
Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic
Have a history of drug or alcohol abuse
Have donated 450 milliliters (mL) or more of blood in the last 3 months
Are unwilling or unable to comply with dietary requirements/restrictions during the study
The study doctor thinks the participant should not participate for any other reasons

Arm && Interventions

Group	Intervention	Description
Cohort 1 - LY2409021 medium test form fed	LY2409021 Test-Med Formulation (medium particle size)	Single 20 mg LY2409021 test form with medium particle size administered orally immediately after ingestion of a standardized high-fat meal
Cohort 1 - LY2409021 medium test form fasted	LY2409021 Test-Med Formulation (medium particle size)	Single 20 mg LY2409021 test form with medium particle size administered orally in the fasted state
Cohort 1 - LY2409021 reference form	LY2409021 Reference Form	A 20 milligram (mg) LY2409021 dose, reference form administered orally in the fasted state
Cohort 2 - LY2409021 high test form fasted	LY2409021 Test-High Formulation (high particle size)	Single 20 mg LY2409021 test form with high particle size administered orally in the fasted state
Cohort 2 - LY2409021 low test form fasted	LY2409021 Test-Low Formulation (low particle size)	Single 20 mg LY2409021 test form with low particle size administered orally in the fasted state
Cohort 2 - LY2409021 medium test form fasted	LY2409021 Test-Med Formulation (medium particle size)	Single 20 mg LY2409021 test form with medium particle size administered orally in the fasted state

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Medium Test Form to Reference Form	Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)	AUC from time 0 to infinity (AUC0-∞).
Pharmacokinetics, Maximum Concentration (Cmax): Medium Test Form to Reference Form	Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Standardized High Fat Meal to Fasting	Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)	AUC from time 0 to infinity (AUC0-∞).
Pharmacokinetics, Maximum Concentration (Cmax): Standardized High Fat Meal to Fasting	Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
Pharmacokinetics, Time to Maximum Concentration (Tmax)	Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Low and High Particle Size to Medium Particle Size	Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)	AUC from time 0 to infinity (AUC0-∞).
Pharmacokinetics, Concentration Maximum (Cmax): Low and High Particle Size to Medium Particle Size	Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)

Locations (1): For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your person physician.
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Singapore, Singapore