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
  Purpose

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 Intervention Phase
Healthy Volunteers
Drug: Placebo
Drug: LY2409021
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: The Effect of LY2409021 on Blood Glucose Concentrations During Hyperglucagonaemia in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Maximum glucose response during a 3-hour glucagon infusion [ Time Frame: During a 3-hour glucagon infusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 21
Study Start Date: November 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01606423

Locations
Singapore
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01606423     History of Changes
Other Study ID Numbers: 11165, I1R-FW-GLBC
Study First Received: May 23, 2012
Last Updated: May 23, 2012
Health Authority: Singapore: Health Sciences Authority

ClinicalTrials.gov processed this record on August 18, 2014