A Study to Compare Two Forms of LY2608204 in Healthy People

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01313286
First received: March 10, 2011
Last updated: May 5, 2011
Last verified: May 2011
  Purpose

The purpose of this study is to compare 2 formulations of the study drug (LY2608204) in terms of how much gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected.


Condition Intervention Phase
Healthy Volunteers
Drug: LY2608204 Reference
Drug: LY2608204 Test
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: The Relative Bioavailability of a Proposed Phase 2 LY2608204 Test Formulation Compared With the Current Phase 1 LY2608204 Reference Formulation After Administration of a Single Oral 80-mg Dose in Healthy Subjects

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Ratio of LY2608204 Test Formulation to LY2608204 Reference Formulation, area under the concentration time curve (AUC) [ Time Frame: For up to 168 hours after each administration of study drug ] [ Designated as safety issue: No ]
  • Ratio of LY2608204 Test Formulation to LY2608204 Reference Formulation, maximum concentration (Cmax) [ Time Frame: For up to 168 hours after each administration of study drug ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: March 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2608204 Reference, LY2608204 Test
Single oral 80 mg dose of LY2608204 reference formulation in period 1; single oral 80 mg dose of LY2608204 test formulation in period 2. There is a washout period of at least 14 days between dosing periods.
Drug: LY2608204 Reference
Administered orally
Other Name: Glucokinase Activator
Drug: LY2608204 Test
Administered orally.
Other Name: Glucokinase Activator
Experimental: LY2608204 Test, LY2608204 Reference
Single oral 80 mg dose of LY2608204 test formulation in period 1; single oral 80 mg dose of LY2608204 reference formulation in period 2. There is a washout period of at least 14 days between dosing periods.
Drug: LY2608204 Reference
Administered orally
Other Name: Glucokinase Activator
Drug: LY2608204 Test
Administered orally.
Other Name: Glucokinase Activator

  Eligibility

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

Inclusion Criteria:

  • Must be a healthy male or a 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
  • Must have given written informed consent

Exclusion Criteria:

  • Were in another new drug or medical research study in the last 30 days
  • Have participated in this study or any other study with LY2608204 before
  • Have taken drugs similar to LY2608204 (glucokinase activators) before and was found to be allergic to the drug
  • Have drug allergy to more than 3 types of medications given by injection
  • 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
  • Are unwilling to follow dietary restrictions/requirements for the study including (i) refrain from consuming foods or beverages containing grapefruit pomelo, star fruit, or Seville orange within 14 days of the start of the study drug dosing until collection of the last blood sample for drug assay; (ii) consume only the meals provided during dosing day at the clinical research unit (CRU)
  • 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 (this is about the same as the usual volume given in a blood donation)
  • The study doctor thinks the subject should not participate for any other reasons
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01313286

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 personal 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 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT01313286     History of Changes
Other Study ID Numbers: 14233, I3P-FW-GKBG
Study First Received: March 10, 2011
Last Updated: May 5, 2011
Health Authority: United States: Food and Drug Administration
Singapore: Domain Specific Review Boards

Keywords provided by Eli Lilly and Company:
Diabetes Mellitus, Type 2

ClinicalTrials.gov processed this record on July 22, 2014