Phase 1
Completed N=18
A Study of LY2605541 in Healthy Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT01877265 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Pharmacokinetics: Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY2605541 — 128000; 145000; 135000 picomoles times hours per liter
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.
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 | — |
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
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. Informational only — not medical advice.