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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01606423
Collaborator
(none)
21
Enrollment
1
Location
6
Arms
4
Duration (Months)
5.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
The Effect of LY2409021 on Blood Glucose Concentrations During Hyperglucagonaemia in Healthy Male Subjects
Study Start Date :
Nov 1, 2007
Actual Primary Completion Date :
Mar 1, 2008
Actual Study Completion Date :
Mar 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Administered once, orally

Drug: Placebo
Administered orally, single dose
Experimental: 10 mg LY2409021

10 mg LY2409021 administered once, orally

Drug: LY2409021
Administered orally, single dose
Experimental: 22.5 mg LY2409021

22.5 mg LY2409021 administered once, orally

Drug: LY2409021
Administered orally, single dose
Experimental: 60 mg LY2409021

60 mg LY2409021 administered once, orally

Drug: LY2409021
Administered orally, single dose
Experimental: 200 mg LY2409021

200 mg LY2409021 administered once, orally

Drug: LY2409021
Administered orally, single dose
Experimental: 500 mg LY2409021

500 mg LY2409021 administered once, orally

Drug: LY2409021
Administered orally, single dose

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
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

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01606423
Other Study ID Numbers:
  • 11165
  • I1R-FW-GLBC
First Posted:
May 25, 2012
Last Update Posted:
May 25, 2012
Last Verified:
May 1, 2012

Study Results

No Results Posted as of May 25, 2012