Clinical trial NCT01877265: A Study of LY2605541 in Healthy Participants
Official title: Assessment of the Impact of Monomethoxy Polyethylene Glycols on the Pharmacokinetics and Glucodynamics of Single Doses of LY2605541 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2013-06-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Pharmacokinetics: Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY2605541
timeFrame: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post dose in each period
measure: Pharmacokinetics: Maximum Concentration (Cmax) of LY2605541
timeFrame: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post dose in each period
Secondary outcomes:
measure: Glucodynamics: Maximum Glucose Infusion Rate (Rmax)
timeFrame: Predose and up to 24 hours post dose in each period
measure: Glucodynamics: Total Amount of Glucose Infused (Gtot)
timeFrame: Predose and up to 24 hours post dose in each period
Other outcomes:
Locations:
city: Dallas
country: United States
facility: 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.
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: