- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01313286
A Study to Compare Two Forms of LY2608204 in Healthy People
October 4, 2018 updated by: Eli Lilly and Company
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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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 personal physician.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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Administered orally
Other Names:
Administered orally.
Other Names:
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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.
|
Administered orally
Other Names:
Administered orally.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 and 168 hours
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Maximum Observed Drug Concentration (Cmax)
Time Frame: Predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 and 168 hours
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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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Predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 and 168 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
March 10, 2011
First Submitted That Met QC Criteria
March 10, 2011
First Posted (Estimate)
March 11, 2011
Study Record Updates
Last Update Posted (Actual)
October 5, 2018
Last Update Submitted That Met QC Criteria
October 4, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14233
- I3P-FW-GKBG (Other Identifier: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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