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

NCT01606423 | Completed Phase 1

• 2 other identifiers: 11165I1R-FW-GLBC
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Maximum glucose response during a 3-hour glucagon infusion

  During a 3-hour glucagon infusion

Secondary Outcomes (2)

• 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

Study Arms (6)

Placebo

PLACEBO COMPARATOR

Administered once, orally

Drug: Placebo

10 mg LY2409021

EXPERIMENTAL

10 mg LY2409021 administered once, orally

Drug: LY2409021

22.5 mg LY2409021

EXPERIMENTAL

22.5 mg LY2409021 administered once, orally

Drug: LY2409021

60 mg LY2409021

EXPERIMENTAL

60 mg LY2409021 administered once, orally

Drug: LY2409021

200 mg LY2409021

EXPERIMENTAL

200 mg LY2409021 administered once, orally

Drug: LY2409021

500 mg LY2409021

EXPERIMENTAL

500 mg LY2409021 administered once, orally

Drug: LY2409021

Interventions

Placebo DRUG

Administered orally, single dose

Placebo

LY2409021 DRUG

Administered orally, single dose

10 mg LY2409021; 200 mg LY2409021; 22.5 mg LY2409021; 500 mg LY2409021; 60 mg LY2409021

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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

Location

MeSH Terms

Interventions

adomeglivant

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2012
• First Posted: May 25, 2012
• Study Start: November 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: May 25, 2012

Record last verified: 2012-05

Locations

SG (1)