A Study of LY2605541 in Healthy Participants

Healthy Volunteers Clinical Trial

Official title:

Assessment of the Impact of Monomethoxy Polyethylene Glycols on the Pharmacokinetics and Glucodynamics of Single Doses of LY2605541 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877265
• Other study ID #: 14594
• Secondary ID: I2R-MC-BIDH
• Status: Completed
• Phase: Phase 1
• Start date: June 2013
• Est. completion date: September 2013

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• LY2605541

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-8]) of LY2605541	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).	Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post dose in each period
Primary	Pharmacokinetics: Maximum Concentration (Cmax) of LY2605541	The maximum observed drug concentration (Cmax) of LY2605541 is summarized for each PEG source (LY1, LY2, or LY3).	Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post dose in each period
Secondary	Glucodynamics: Maximum Glucose Infusion Rate (Rmax)	The maximum observed glucose infusion rate following LY2605541 injection is summarized for each PEG source (LY1, LY2, or LY3).	Predose and up to 24 hours post dose in each period
Secondary	Glucodynamics: Total Amount of Glucose Infused (Gtot)	The total amount of glucose infused following LY2605541 injection is summarized for each PEG source (LY1, LY2, or LY3).	Predose and up to 24 hours post dose in each period