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OpenTrials
Completed

NCT Number: NCT01877265

A Study of LY2605541 in Healthy Participants

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY2605541

Drug

Primary outcomes

  1. Pharmacokinetics: Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY2605541

    Time frame: 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).

  2. Pharmacokinetics: Maximum Concentration (Cmax) of LY2605541

    Time frame: 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 outcomes

  1. Glucodynamics: Maximum Glucose Infusion Rate (Rmax)

    Time frame: 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).

  2. Glucodynamics: Total Amount of Glucose Infused (Gtot)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 13, 2013
Registry last updated
Oct 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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