A Study of Insulin Peglispro in Healthy Male Japanese Participants
- Registration Number
- NCT01995526
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to evaluate how the body processes the study drug known as insulin peglispro and how the study drug affects blood sugar in healthy male Japanese participants. This study will also evaluate safety of the study drug. The study will last up to 46 days for each participant, not including screening.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 11
Inclusion Criteria
- Participants are overtly healthy male Japanese.
- Participants have Body Mass Index (BMI) between 18.5 and 25.0 kilograms per square meter (kg/m^2), inclusive.
Exclusion Criteria
- Participants have known allergies to insulin peglispro or related compounds.
- Participants have a fasting venous blood glucose >108 milligrams per deciliter (mg/dL) (>6 millimoles per liter [mmol/L]).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Insulin Peglispro Insulin Peglispro Single subcutaneous dose of 1.3 Units per kilogram (U/kg) insulin peglispro on Day 1.
- Primary Outcome Measures
Name Time Method Pharmacokinetics: Observed Maximum Concentration (Cmax) of Insulin Peglispro Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose Pharmacokinetics: Area Under the Concentration Curve (AUC) of Insulin Peglispro Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose AUC from time zero to infinity (AUC\[0-∞\]) of insulin peglispro was evaluated.
Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Insulin Peglispro Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose Glucodynamics: Maximum Glucose Infusion Rate (Rmax) Predose up to 36 hours post clamp procedure Glucodynamics: Total Amount of Glucose Infused (Gtot) Predose up to 36 hours post clamp procedure.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇯🇵Fukuoka, Japan