A Study of Insulin Peglispro in Healthy Male Japanese Participants

A Single Dose Study to Evaluate the Pharmacokinetics and Glucodynamics of Insulin Peglispro (LY2605541) in Healthy Male Japanese Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Insulin Peglispro

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 812-0025
    • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Insulin Peglispro; Single subcutaneous dose of 1.3 Units per kilogram (U/kg) insulin peglispro on Day 1.	Drug: Insulin Peglispro; Other Names: LY2605541

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	AUC from time zero to infinity (AUC[0-∞]) of insulin peglispro was evaluated.	Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose
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.

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: November 21, 2013
• First Submitted That Met QC Criteria: November 21, 2013
• First Posted (Estimate): November 26, 2013

Study Record Updates

• Last Update Posted (Actual): October 19, 2018
• Last Update Submitted That Met QC Criteria: March 17, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: 14682; I2R-JE-BIDK (Other Identifier: Eli Lilly and Company)