The Effect of LY2409021 on Blood Glucose Concentrations During Hyperglucagonaemia in Healthy Male Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Maximum glucose response during a 3-hour glucagon infusion
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 21 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
10 mg LY2409021
10 mg LY2409021 administered once, orally
Intervention: LY2409021 (Drug)
Placebo
Administered once, orally
Intervention: Placebo (Drug)
22.5 mg LY2409021
22.5 mg LY2409021 administered once, orally
Intervention: LY2409021 (Drug)
60 mg LY2409021
60 mg LY2409021 administered once, orally
Intervention: LY2409021 (Drug)
200 mg LY2409021
200 mg LY2409021 administered once, orally
Intervention: LY2409021 (Drug)
500 mg LY2409021
500 mg LY2409021 administered once, orally
Intervention: LY2409021 (Drug)
Outcomes
Primary Outcomes
Maximum glucose response during a 3-hour glucagon infusion
Time Frame: During a 3-hour glucagon infusion
Secondary Outcomes
- 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)