A Study of LY2605541 in Healthy Participants

NCT ID: NCT01877265

Last Updated: 2018-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2013-09-30

Brief Summary

This study looks at the amount of LY2605541 in the body after it is injected under the skin. The study has 3 periods, each lasting 10 days. Each participant will receive one injection in each period. At least 14 days will pass between each injection.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

LY2605541 - Source 1

Each healthy participant will receive a single subcutaneous (SC) injection of 0.5 units per kilogram (U/kg) of LY2605541 on Day 1 of 1 of 3 treatment periods

Group Type: EXPERIMENTAL

LY2605541

Intervention Type: DRUG

LY2605541 - Source 2

Each healthy participant will receive single SC injection of 0.5 U/kg of LY2605541 on Day 1 of 1of 3 treatment periods

Group Type: EXPERIMENTAL

LY2605541

Intervention Type: DRUG

LY2605541 - Source 3

Each healthy participant will receive single SC injection of 0.5 U/kg of LY2605541 on Day 1 of 1 of 3 treatment periods

Group Type: EXPERIMENTAL

LY2605541

Intervention Type: DRUG

Interventions

LY2605541

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Are overtly healthy males or females, as determined by medical history and physical examination
• A body mass index of 18.5 to 30 kilograms per meter square (kg/m^2)

Exclusion Criteria

• Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
• Are women with a positive pregnancy test or are women who are lactating
• Intend to use over-the-counter medication within 7 days prior to dosing or prescription medication within 14 days prior to dosing (apart from contraceptive medication, vitamin/mineral supplements, occasional acetaminophen, and/or hormone replacement therapy)
• Have donated blood of more than 500 milliliters (mL) within the last month
• Have an average weekly alcohol intake that exceeds 21 units per week (for males) and 14 units per week (for females)
• Are excessive consumers of xanthines (more than 10 cups of tea, coffee, cola, or hot chocolate per day)
• Have a fasting blood glucose (BG) >110 milligrams per deciliter (mg/dL) (6.1 millimoles per liter [mmol/L])
• Currently smoke more than 10 cigarettes per day, or are unwilling to refrain from smoking for 72 hours prior to each dosing occasion and during confinement

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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.

Dallas, Texas, United States

Countries

United States

Other Identifiers

I2R-MC-BIDH

Identifier Type: OTHER

Identifier Source: secondary_id

14594

Identifier Type: -

Identifier Source: org_study_id