Pharmacokinetics, Glucodynamics, Safety, and Tolerability of a Novel LY900014 Formulation
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics (PK) : Insulin Lispro Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) )
Study Overview
Brief Summary
This study evaluates a new formulation of LY900014, a drug that lowers blood sugar. It is administered by injection under the skin of the abdomen. The study will be conducted in healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of different doses of LY900014 on blood sugar levels. Side effects and tolerability will be documented. The study will last for about 8 to 9 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering 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 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until one month after study completion)
- •Have a body mass index (BMI) of 18.5 to 30 kilogram per square meter (kg/m^2), inclusive, at screening
- •Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
- •Are nonsmokers, have not smoked for at least 2 months prior to entering the study, and agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the duration of the study
Exclusion Criteria
- •Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
- •Have previously participated or withdrawn from this study
- •Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
Arms & Interventions
LY900014 7.5 Units (U)
Single dose of 7.5 U LY900014 administered subcutaneously (SC) in one to two of five periods.
Intervention: LY900014 (Drug)
Insulin Lispro
Reference formulation. Single dose of Insulin Lispro administered SC in one to two of five periods.
Intervention: Insulin Lispro (Humalog) (Drug)
LY900014 15 U
Single dose of 15 U LY900014 administered subcutaneously (SC) in one to two of five periods.
Intervention: LY900014 (Drug)
LY900014 30 U
Single dose of 30 U LY900014 administered subcutaneously (SC) in one to two of five periods.
Intervention: LY900014 (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics (PK) : Insulin Lispro Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) )
Time Frame: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes per period.
Secondary Outcomes
- Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp(Every 10 minutes for 30 minutes Predose, Postdose: every 2.5 minutes for 30 minutes, then every 5 minutes until 120 minutes, then every 10 minutes until 300 minutes, then every 20 minutes until 480 minutes)