A Study of LY2409021 Formulations and the Effect of Food

Healthy Volunteers Clinical Trial

Official title:

LY2409021 Formulation Bridging and Food Effect Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01354496
• Other study ID #: 14194
• Secondary ID: I1R-FW-GLBQ
• Status: Completed
• Phase: Phase 1
• Start date: April 2011
• Est. completion date: October 2011

Study information

• Verified date: November 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
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.	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Medium Test Form to Reference Form	AUC from time 0 to infinity (AUC0-8).	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)
Primary	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	Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Standardized High Fat Meal to Fasting	AUC from time 0 to infinity (AUC0-8).	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	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)
Secondary	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)
Secondary	Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Low and High Particle Size to Medium Particle Size	AUC from time 0 to infinity (AUC0-8).	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	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)