A Study of LY2605541 in Healthy Participants
- Conditions
- Healthy Volunteers
- Interventions
- Drug: LY2605541
- Registration Number
- NCT01877265
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description LY2605541 - Source 1 LY2605541 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 LY2605541 - Source 2 LY2605541 Each healthy participant will receive single SC injection of 0.5 U/kg of LY2605541 on Day 1 of 1of 3 treatment periods LY2605541 - Source 3 LY2605541 Each healthy participant will receive single SC injection of 0.5 U/kg of LY2605541 on Day 1 of 1 of 3 treatment periods
- Primary Outcome Measures
Name Time Method Pharmacokinetics: Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY2605541 Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post dose in each period LY2605541 exposure in terms of AUC from time 0 extrapolated to infinity (AUC\[0-inf\]) is summarized for each PEG source (LY1, LY2, or LY3).
Pharmacokinetics: Maximum Concentration (Cmax) of LY2605541 Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post dose in each period The maximum observed drug concentration (Cmax) of LY2605541 is summarized for each PEG source (LY1, LY2, or LY3).
- Secondary Outcome Measures
Name Time Method Glucodynamics: Maximum Glucose Infusion Rate (Rmax) Predose and up to 24 hours post dose in each period The maximum observed glucose infusion rate following LY2605541 injection is summarized for each PEG source (LY1, LY2, or LY3).
Glucodynamics: Total Amount of Glucose Infused (Gtot) Predose and up to 24 hours post dose in each period The total amount of glucose infused following LY2605541 injection is summarized for each PEG source (LY1, LY2, or LY3).
Trial Locations
- Locations (1)
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