Bioequivalence Study Evaluating the Pharmacokinetics of DMB-3111 and Trastuzumab in Healthy Japanese Male Adults

February 9, 2015 updated by: Meiji Seika Pharma Co., Ltd.
This study is a randomized Trastuzumab-controlled double-blind parallel-group study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

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

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 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Healthy Japanese male adults
  2. Body Mass Index (BMI) between 17.6 and 26.4 kg/m² at the time of screening BMI = Body Weight (kg)/[Height (m)]²
  3. The individual who freely consents to participate after receiving a detailed explanation of the clinical study and completely understanding thereof, and who has capacity to follow precautions and provide written consent.

Exclusion Criteria:

  1. History of hypersensitivity to components of Trastuzumab or diphenhydramine or any other drug
  2. Use of any ethical drug within 2 weeks before investigational product administration or any over-the-counter drug within 1 week before investigational product administration that would affect study participation in the opinion of the investigator or subinvestigators (except for diphenhydramine, which will be used concomitantly in the present clinical trial and any drug applied locally and having no systemic actions)
  3. History of allergic symptoms such as bronchial asthma and urticaria that would affect study participation in the opinion of the investigator or subinvestigators
  4. History of cardiac disorders, hypertension, coronary artery disease (e.g., myocardial infarction, angina), and/or vascular disorder; ongoing palpitations, shortness of breath, and/or tachycardia

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DMB-3111
6 mg/kg is once given in intravenous drip infusion taking 90 min
Drug: DMB-3111
Active Comparator: trastuzumab
6 mg/kg is once given in intravenous drip infusion taking 90 min
Drug: trastuzumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area Under the Concentration-Time (AUC)
Time Frame: Day1-71
Day1-71
Maximum observed serum concentration (Cmax)
Time Frame: Day1-71
Day1-71

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the concentration-time curve (AUC) from 0 to time of the last measurable concentration
Time Frame: Day1-71
Day1-71
Area under the concentration-time curve (AUC) from 0 to infinity
Time Frame: Day1-71
Day1-71
Time to reach the peak concentration (tmax)
Time Frame: Day1-71
Day1-71
Mean residence time (MRT) from 0 to final sampling time point
Time Frame: Day1-71
Day1-71
Mean residence time (MRT) from 0 to infinity
Time Frame: Day1-71
Day1-71
elimination rate constant (kel)
Time Frame: Day1-71
Day1-71
Elimination half life (t1/2)
Time Frame: Day1-71
Day1-71
Clearance (CL)
Time Frame: Day1-71
Day1-71
Incidence of adverse events
Time Frame: Day1-71
Day1-71

Other Outcome Measures

Outcome Measure
Time Frame
Incidence of anti-trastuzumab antibodies (ADAs)
Time Frame: Day1-71
Day1-71

Collaborators and Investigators

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

Sponsor

Meiji Seika Pharma Co., Ltd.

Collaborators

Dong-A Pharmaceutical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2014

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 27, 2014

First Submitted That Met QC Criteria

March 27, 2014

First Posted (Estimate)

April 1, 2014

Study Record Updates

Last Update Posted (Estimate)

February 10, 2015

Last Update Submitted That Met QC Criteria

February 9, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMB-3111-2
  • JapicCTI-142486 (Registry Identifier: Japan Primary Registries Network)

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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