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A Study to Compare Two Forms of LY2608204 in Healthy People

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ClinicalTrials.gov Identifier: NCT01313286
Recruitment Status : Completed
First Posted : March 11, 2011
Results First Posted : October 5, 2018
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Volunteers Drug: LY2608204 Reference Drug: LY2608204 Test Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : March 2011
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) [ Time Frame: Predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 and 168 hours ]
    Area under the concentration versus time curve from zero to infinity [AUC(0-∞)] was calculated from the data. The values for AUC were log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence and period, and a random factor for subject.

  2. Maximum Observed Drug Concentration (Cmax) [ Time Frame: Predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 and 168 hours ]
    Maximum observed drug concentration (Cmax) was observed from the data. The values for Cmax were log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence and period, and a random factor for subject.



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 milliliter (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01313286     History of Changes
Other Study ID Numbers: 14233
I3P-FW-GKBG ( Other Identifier: Eli Lilly and Company )
First Posted: March 11, 2011    Key Record Dates
Results First Posted: October 5, 2018
Last Update Posted: October 5, 2018
Last Verified: October 2018

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