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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: LY2409021; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01606423

I1R-FW-GLBC (Other Identifier)

11165 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: Male

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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21 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Administered once, orally

Treatment:

Drug: Placebo

10 mg LY2409021

Experimental group

Description:

10 mg LY2409021 administered once, orally

Treatment:

Drug: LY2409021

22.5 mg LY2409021

Experimental group

Description:

22.5 mg LY2409021 administered once, orally

Treatment:

Drug: LY2409021

60 mg LY2409021

Experimental group

Description:

60 mg LY2409021 administered once, orally

Treatment:

Drug: LY2409021

200 mg LY2409021

Experimental group

Description:

200 mg LY2409021 administered once, orally

Treatment:

Drug: LY2409021

500 mg LY2409021

Experimental group

Description:

500 mg LY2409021 administered once, orally

Treatment:

Drug: LY2409021