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Completed

NCT Number: NCT01995526

A Study of Insulin Peglispro in Healthy Male Japanese Participants

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.

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Key information

Conditions

Healthy Volunteers

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

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, 812-0025, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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]).

Treatment and study plan

Insulin Peglispro

Drug

Other names: LY2605541

Primary outcomes

  1. Pharmacokinetics: Observed Maximum Concentration (Cmax) of Insulin Peglispro

    Time frame: Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose

  2. Pharmacokinetics: Area Under the Concentration Curve (AUC) of Insulin Peglispro

    Time frame: 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.

  3. Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Insulin Peglispro

    Time frame: Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose

  4. Glucodynamics: Maximum Glucose Infusion Rate (Rmax)

    Time frame: Predose up to 36 hours post clamp procedure

  5. Glucodynamics: Total Amount of Glucose Infused (Gtot)

    Time frame: Predose up to 36 hours post clamp procedure.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 26, 2013
Registry last updated
Oct 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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