A Study of LY2409021 Formulations and the Effect of Food

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01354496
First received: May 13, 2011
Last updated: November 7, 2011
Last verified: November 2011
  Purpose

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. Subjects 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.


Condition Intervention Phase
Healthy Volunteers
Drug: LY2409021 Reference Form
Drug: LY2409021 Test-Med Formulation (medium particle size)
Drug: LY2409021 Test-High Formulation (high particle size)
Drug: LY2409021 Test-Low Formulation (low particle size)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: LY2409021 Formulation Bridging and Food Effect Study

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Pharmacokinetics, area under the concentration time curve (AUC): ratio: medium test form to reference form [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours post dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics maximum concentration (Cmax): ratio: medium test form to reference form [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics, area under the concentration-time curve (AUC): ratio: standardized high fat meal to fasting [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours post dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics, maximum concentration (Cmax): ratio: standardized high fat meal to fasting [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours post dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics, time to maximum concentration (tmax) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours post dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics, area under the concentration time curve (AUC): ratios of low and high particle size to medium particle size [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours post dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics, concentration maximum (Cmax): ratios of low and high particle size to medium particle size [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours post dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: April 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 - LY2409021 reference form
Single 20 mg LY2409021 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

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 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 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 subject should not participate for any other reasons
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354496

Locations
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, Singapore
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01354496     History of Changes
Other Study ID Numbers: 14194, I1R-FW-GLBQ
Study First Received: May 13, 2011
Last Updated: November 7, 2011
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by Eli Lilly and Company:
Healthy Volunteers
Bioavailability

ClinicalTrials.gov processed this record on April 23, 2014