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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01606423
First received: May 23, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted

May 23, 2012
May 23, 2012
November 2007
March 2008   (final data collection date for primary outcome measure)
Maximum glucose response during a 3-hour glucagon infusion [ Time Frame: During a 3-hour glucagon infusion ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Total glucose released from the liver during a 3-hour glucagon infusion [ Time Frame: During a 3-hour glucagon infusion ] [ Designated as safety issue: No ]
  • Maximum glucose release from the liver during a 3-hour glucagon infusion [ Time Frame: During a 3-hour glucagon infusion ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effect of LY2409021 on Blood Sugar Levels When Glucagon Levels Are Increased in Healthy Male Participants
The Effect of LY2409021 on Blood Glucose Concentrations During Hyperglucagonaemia in Healthy Male Subjects

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Healthy Volunteers
  • Drug: Placebo
    Administered orally, single dose
  • Drug: LY2409021
    Administered orally, single dose
  • Placebo Comparator: Placebo
    Administered once, orally
    Intervention: Drug: Placebo
  • Experimental: 10 mg LY2409021
    10 mg LY2409021 administered once, orally
    Intervention: Drug: LY2409021
  • Experimental: 22.5 mg LY2409021
    22.5 mg LY2409021 administered once, orally
    Intervention: Drug: LY2409021
  • Experimental: 60 mg LY2409021
    60 mg LY2409021 administered once, orally
    Intervention: Drug: LY2409021
  • Experimental: 200 mg LY2409021
    200 mg LY2409021 administered once, orally
    Intervention: Drug: LY2409021
  • Experimental: 500 mg LY2409021
    500 mg LY2409021 administered once, orally
    Intervention: Drug: LY2409021
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
March 2008
March 2008   (final data collection date for primary outcome measure)

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
Male
21 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01606423
11165, I1R-FW-GLBC
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP