An Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects

May 27, 2016 updated by: Adocia

A Double-blind, Comparator-controlled, Randomised, Three-period Crossover Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects

This is a double-blind, randomised, three period crossover phase 1 trial using automated 8-hour euglycemic clamps in healthy Japanese subjects.

Each subject will be randomly allocated to one out of nine sequences to receive either three single doses of BioChaperone insulin lispro or one single dose of Humalog® and two single doses of BioChaperone insulin lispro on three separate dosing visits.

The total trial maximum duration for a subject will be up to 10 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Neuss, Germany, 41460
        • Profil Institut für Stoffwechselforschung GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy Japanese male or female subjects by completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
  • BMI between 18.5 and 25.0 kg∙m-2, both inclusive.
  • Fasting Plasma Glucose ≤ 5.6 mmol/L (100 mg/dL).
  • Signed and dated informed consent obtained before any trial-related activities.

Exclusion Criteria:

  • Known or suspected hypersensitivity to trial product(s) or related products.
  • Receipt of any investigational medicinal product within 3 months before randomisation in this trial.
  • Any history or presence of a life threatening disease (i.e. cancer except basal cell skin cancer or squamous cell skin cancer), or of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (including type 1 and type 2 diabetes mellitus, haematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the investigator.
  • History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Humalog®
Drug: Humalog®
Injection of a single dose of Humalog® at the dose of 0.2 U/kg
Experimental: BioChaperone insulin lispro 0.1 U/kg
Drug: Biochaperone insulin lispro 0.1 U/kg
Injection of a single dose of BioChaperone insulin lispro at the dose of 0.1 U/kg
Experimental: BioChaperone insulin lispro 0.2 U/kg
Drug: Biochaperone insulin lispro 0.2 U/kg
Injection of a single dose of BioChaperone insulin lispro at the dose of 0.2 U/kg
Experimental: BioChaperone insulin lispro 0.4 U/kg
Drug: Biochaperone insulin lispro 0.4 U/kg
Injection of a single dose of BioChaperone insulin lispro at the dose of 0.4 U/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCLispro(0-30min)
Time Frame: Up to 30 minutes
Area under the insulin lispro serum concentration - time curve from t=0 to 30 minutes
Up to 30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCGIR(0-last)
Time Frame: Up to 8 hours
Area under the glucose infusion rate time curve from 0 hours until the end of clamp
Up to 8 hours
Adverse Events
Time Frame: Up to 10 weeks
Number of adverse events
Up to 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adocia

Collaborators

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

January 18, 2016

First Submitted That Met QC Criteria

January 20, 2016

First Posted (Estimate)

January 21, 2016

Study Record Updates

Last Update Posted (Estimate)

May 30, 2016

Last Update Submitted That Met QC Criteria

May 27, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC3-CT017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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