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

Study Overview
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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.

Official Title
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The Effect of LY2409021 on Blood Glucose Concentrations During Hyperglucagonaemia in Healthy Male Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Placebo
* Drug: LY2409021


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Administered once, orally | Drug: Placebo<br>* Administered orally, single dose<br>|
| Experimental: 10 mg LY2409021<br>10 mg LY2409021 administered once, orally | Drug: LY2409021<br>* Administered orally, single dose<br>|
| Experimental: 22.5 mg LY2409021<br>22.5 mg LY2409021 administered once, orally | Drug: LY2409021<br>* Administered orally, single dose<br>|
| Experimental: 60 mg LY2409021<br>60 mg LY2409021 administered once, orally | Drug: LY2409021<br>* Administered orally, single dose<br>|
| Experimental: 200 mg LY2409021<br>200 mg LY2409021 administered once, orally | Drug: LY2409021<br>* Administered orally, single dose<br>|
| Experimental: 500 mg LY2409021<br>500 mg LY2409021 administered once, orally | Drug: LY2409021<br>* Administered orally, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum glucose response during a 3-hour glucagon infusion |  | During a 3-hour glucagon infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |