NCT01374178CompletedPhase 1
Relative Bioavailability of LY2963016 to LANTUS® After Single Dose Subcutaneous Administration to Healthy Subjects
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics: Area Under the Concentration-Time Curve (AUC)
Study Overview
Brief Summary
The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of LY2963016 compared to those of basal insulin. The study will also gather information on the safety and tolerability of LY2963016 in healthy subjects. The study is approximately 12 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Are overtly healthy males or females
- •Have a body mass index (BMI) between 18.5 and 29.9 kilogram per square meter (kg/m^2)
- •Are nonsmokers
- •Have normal blood pressure and pulse rate
- •Have an electrocardiogram (ECG) considered as within normal limits
- •Have clinical laboratory test results within normal reference range
Exclusion Criteria
- •Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device
- •Have known allergies to insulin or its excipients
- •Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
- •Show evidence of significant active neuropsychiatric disease
- •Have a history of first-degree relatives known to have diabetes mellitus
- •Have a fasting venous blood glucose >6.0 millimoles per liter (mmol/L)
- •Intend to use over-the-counter or prescription medication
- •Have donated or had a blood loss of 450 milliliters (mL) or more in the past 3 months
- •Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females)
Arms & Interventions
LY2963016
Experimental
A single 0.5-unit per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously.
Intervention: LY2963016 (Drug)
Lantus
Active Comparator
A single 0.5-U/kg dose of Lantus will be administered subcutaneously.
Intervention: Lantus (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC)
Time Frame: Periods 1 and 2: Baseline up to 24 hours
AUC from time zero to 24 hours (AUC0-24) is reported for this outcome measure.
Secondary Outcomes
- Pharmacokinetics: Maximum Concentration (Cmax)(Periods 1 and 2: Baseline up to 24 hours)
- Time of Maximum Glucose Infusion Rate (tRmax)(Periods 1 and 2: Baseline up to 24 hours)
- Maximum Glucose Infusion Rate (Rmax)(Periods 1 and 2: Baseline up to 24 hours)
- Total Glucose Infused (Gtot)(Periods 1 and 2: Baseline up to 24 hours)
- Number of Participants With Clinically Significant Effects(Baseline up to 30 days)
Investigators
Study Sites (1)
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