A Study to Compare Two Forms of LY2608204 in Healthy People | NCT01313286

NCT01313286

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
I3P-FW-GKBG	Other Identifier	Eli Lilly and Company

Status Module

Oversight Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LY2608204 Reference, LY2608204 Test	Experimental	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 Drug: LY2608204 Test
LY2608204 Test, LY2608204 Reference	Experimental	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 Drug: LY2608204 Test

Name	Type	Description	Arm Group Labels	Other Names
LY2608204 Reference	Drug	Administered orally	LY2608204 Reference, LY2608204 Test LY2608204 Test, LY2608204 Reference

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])	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.	Predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 and 168 hours
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

Eligibility Module

Eligibility 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

Contacts/Locations Module

Name	Affiliation	Role
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	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
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

Arm/Group Information

ID	Title	Description
FG000	LY2608204 Reference, LY2608204 Test	A single oral dose of 80 mg LY2608204 reference formulation in Period 1 and a single oral dose of 80 mg LY2608204 test formulation in Period 2. There is a washout period of at least 14 days between dosing periods.
FG001	LY2608204 Test, LY2608204 Reference	A single oral dose of 80 mg LY2608204 test formulation in Period 1 and a single oral dose of 80 mg LY2608204 reference formulation in Period 2. There is a washout period of at least 14 days between dosing periods.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	All Participants	A single oral dose of 80 mg LY2608204 reference formulation in Period 1 and a single oral dose of 80 mg LY2608204 test formulation in Period 2; or a single oral dose of 80 mg test formulation in Period 1 and a single oral dose of 80 mg reference formulation in Period 2. There is a washout period of at least 14 days between dosing periods.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])

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.

All randomized participants who took at least one dose of study drug.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanogram.hour per milliliter (ng.h/mL)

Predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 and 168 hours

ID	Title	Description
OG000	LY2608204 Free Base (Reference Formulation)	a single oral dose of 80 mg LY2608204 reference formulation (free base)
OG001

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	LY2608204 Reference Formulation	A single oral dose of 80 mg LY2608204 reference formulation.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases