A Study to Compare Two Forms of LY2608204 in Healthy People

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01313286
• Other study ID #: 14233
• Secondary ID: I3P-FW-GKBG
• Status: Completed
• Phase: Phase 1
• Start date: March 2011
• Est. completion date: April 2011

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• LY2608204 Reference
Administered orally
• LY2608204 Test
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 personal 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	Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-8])	Area under the concentration versus time curve from zero to infinity [AUC(0-8)] 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.	Predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 and 168 hours
Primary	Maximum Observed Drug Concentration (Cmax)	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.	Predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 and 168 hours