Phase 1 N=18 Randomized Double-blind Basic Science

A Study of LY2605541 in Healthy Participants

Healthy Volunteers

Bottom Line

View on ClinicalTrials.gov: NCT01877265 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2018

Primary outcome: Primary: Pharmacokinetics: Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY2605541 — 128000; 145000; 135000 picomoles times hours per liter

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: LY2605541 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Sep 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Pharmacokinetics: Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY2605541	128000; 145000; 135000	—
PRIMARY Pharmacokinetics: Maximum Concentration (Cmax) of LY2605541	1980; 2490; 2210	—
SECONDARY Glucodynamics: Maximum Glucose Infusion Rate (Rmax)	1.21; 1.31; 1.40	—
SECONDARY Glucodynamics: Total Amount of Glucose Infused (Gtot)	900; 963; 1190	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01877265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.