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

NCT ID: NCT01606423

Last Updated: 2012-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-03-31

Brief Summary

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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

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

Administered once, orally

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally, single dose

10 mg LY2409021

10 mg LY2409021 administered once, orally

Group Type EXPERIMENTAL

LY2409021

Intervention Type DRUG

Administered orally, single dose

22.5 mg LY2409021

22.5 mg LY2409021 administered once, orally

Group Type EXPERIMENTAL

LY2409021

Intervention Type DRUG

Administered orally, single dose

60 mg LY2409021

60 mg LY2409021 administered once, orally

Group Type EXPERIMENTAL

LY2409021

Intervention Type DRUG

Administered orally, single dose

200 mg LY2409021

200 mg LY2409021 administered once, orally

Group Type EXPERIMENTAL

LY2409021

Intervention Type DRUG

Administered orally, single dose

500 mg LY2409021

500 mg LY2409021 administered once, orally

Group Type EXPERIMENTAL

LY2409021

Intervention Type DRUG

Administered orally, single dose

Interventions

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Placebo

Administered orally, single dose

Intervention Type DRUG

LY2409021

Administered orally, single dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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

Site Status

Countries

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Singapore

Other Identifiers

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I1R-FW-GLBC

Identifier Type: OTHER

Identifier Source: secondary_id

11165

Identifier Type: -

Identifier Source: org_study_id

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