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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Placebo; Drug: LY2409021

• Registration Number: NCT01606423
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2012-05
• Study First Submitted: 2012-05-23
• Study First Submitted QC: 2012-05-23
• Last Update Submitted: 2012-05-23
• Study First Posted: 2012-05-25
• Last Update Posted: 2012-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Administered once, orally
10 mg LY2409021	LY2409021	10 mg LY2409021 administered once, orally
22.5 mg LY2409021	LY2409021	22.5 mg LY2409021 administered once, orally
60 mg LY2409021	LY2409021	60 mg LY2409021 administered once, orally
200 mg LY2409021	LY2409021	200 mg LY2409021 administered once, orally
500 mg LY2409021	LY2409021	500 mg LY2409021 administered once, orally

Primary Outcome Measures

Name	Time	Method
Maximum glucose response during a 3-hour glucagon infusion	During a 3-hour glucagon infusion

Secondary Outcome Measures

Name	Time	Method
Total glucose released from the liver during a 3-hour glucagon infusion	During a 3-hour glucagon infusion
Maximum glucose release from the liver during a 3-hour glucagon infusion	During a 3-hour glucagon infusion

Trial Locations

Locations (1)

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, Singapore