A Study of Insulin Peglispro in Healthy Male Japanese Participants

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01995526
• Other study ID #: 14682
• Secondary ID: I2R-JE-BIDK
• Status: Completed
• Phase: Phase 1
• Start date: December 2013
• Est. completion date: January 2014

Study information

• Verified date: March 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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]).

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Insulin Peglispro

Locations

Country	Name	City	State
Japan	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: Observed Maximum Concentration (Cmax) of Insulin Peglispro		Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose
Primary	Pharmacokinetics: Area Under the Concentration Curve (AUC) of Insulin Peglispro	AUC from time zero to infinity (AUC[0-8]) of insulin peglispro was evaluated.	Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose
Primary	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
Primary	Glucodynamics: Maximum Glucose Infusion Rate (Rmax)		Predose up to 36 hours post clamp procedure
Primary	Glucodynamics: Total Amount of Glucose Infused (Gtot)		Predose up to 36 hours post clamp procedure.