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

Healthy Volunteer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02100917
• Other study ID #: DMB-3111-2
• Secondary ID: JapicCTI-142486
• Status: Completed
• Phase: Phase 1
• First received: March 27, 2014
• Last updated: February 9, 2015
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Meiji Seika Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

This study is a randomized Trastuzumab-controlled double-blind parallel-group study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 39 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• DMB-3111

• trastuzumab

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Meiji Seika Pharma Co., Ltd.	Dong-A

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of anti-trastuzumab antibodies (ADAs)		Day1-71	Yes
Primary	Area Under the Concentration-Time (AUC)		Day1-71	No
Primary	Maximum observed serum concentration (Cmax)		Day1-71	No
Secondary	Area under the concentration-time curve (AUC) from 0 to time of the last measurable concentration		Day1-71	No
Secondary	Area under the concentration-time curve (AUC) from 0 to infinity		Day1-71	No
Secondary	Time to reach the peak concentration (tmax)		Day1-71	No
Secondary	Mean residence time (MRT) from 0 to final sampling time point		Day1-71	No
Secondary	Mean residence time (MRT) from 0 to infinity		Day1-71	No
Secondary	elimination rate constant (kel)		Day1-71	No
Secondary	Elimination half life (t1/2)		Day1-71	No
Secondary	Clearance (CL)		Day1-71	No
Secondary	Incidence of adverse events		Day1-71	Yes