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Completed

NCT Number: NCT01606423

The Effect of LY2409021 on Blood Sugar Levels When Glucagon Levels Are Increased in Healthy Male Participants

This is a study to measure the effect that various doses of LY2409021 have on blood sugar levels and on the amount of glucose released by the liver, when glucagon is given to increase these. Each participant may receive up to 2 single doses of LY2409021 in 2 different study periods, with a minimum 13-day washout between dosing periods. This study is approximately 9 weeks long, not including screening. A screening appointment is required within 6 weeks prior to the start of the study.

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Key information

Conditions

Healthy Volunteers

Age range

21 year–55 year

Sex eligibility

Male

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.

Singapore

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Must be a healthy male
  • Have a screening body mass index (BMI) of 18.5 to 29.9 kg/m^2 inclusive
  • Have a fasting blood glucose between 3.0-6.0 millimoles/liter (mmol/L) (inclusive) at screening

Exclusion criteria

  • Are allergic to LY2409021, insulin, glucagon, somatostatin, or similar drugs
  • Have a regular alcohol intake greater than 21 units/week, or are unwilling to stop alcohol as required by the study restrictions (1 unit = 360 mL of beer, or 150 mL of wine, or 45 mL of spirits)
  • Are currently smokers or have used tobacco products on a regular basis in the 6 months prior to screening
  • Have received any medication known to affect glucose metabolism in the 1 month before the study
  • Have a significant blood disorder and/or donated blood (450 mL or more) in the last 3 months

Treatment and study plan

Placebo

Drug

Administered orally, single dose

LY2409021

Drug

Administered orally, single dose

Primary outcomes

  1. Maximum glucose response during a 3-hour glucagon infusion

    Time frame: During a 3-hour glucagon infusion

Secondary outcomes

  1. Total glucose released from the liver during a 3-hour glucagon infusion

    Time frame: During a 3-hour glucagon infusion

  2. Maximum glucose release from the liver during a 3-hour glucagon infusion

    Time frame: During a 3-hour glucagon infusion

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

The Effect of LY2409021 on Blood Glucose Concentrations During Hyperglucagonaemia in Healthy Male Subjects

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 25, 2012
Registry last updated
May 25, 2012

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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