A Study of LY2409021 Formulations and the Effect of Food

LY2409021 Formulation Bridging and Food Effect Study

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: LY2409021 Reference Form; Drug: LY2409021 Test-Med Formulation (medium particle size); Drug: LY2409021 Test-Low Formulation (low particle size); Drug: LY2409021 Test-High Formulation (high particle size)

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Medium Test Form to Reference Form	AUC from time 0 to infinity (AUC0-∞).	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, 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

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Standardized High Fat Meal to Fasting	AUC from time 0 to infinity (AUC0-∞).	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, 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	AUC from time 0 to infinity (AUC0-∞).	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, 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)

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: May 13, 2011
• First Submitted That Met QC Criteria: May 13, 2011
• First Posted (Estimate): May 17, 2011

Study Record Updates

• Last Update Posted (Actual): March 11, 2019
• Last Update Submitted That Met QC Criteria: November 19, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Healthy Volunteers; Bioavailability
• Other Study ID Numbers: 14194; I1R-FW-GLBQ (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO