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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: DMB-3111; Drug: trastuzumab

• Registration Number: NCT02100917
• Lead Sponsor: Meiji Seika Pharma Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-03-27
• Study First Submitted QC: 2014-03-27
• Study First Posted: 2014-04-01
• Primary Completion: 2014-05
• Study Completion: 2014-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-09
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DMB-3111	DMB-3111	6 mg/kg is once given in intravenous drip infusion taking 90 min
trastuzumab	trastuzumab	6 mg/kg is once given in intravenous drip infusion taking 90 min

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-Time (AUC)	Day1-71
Maximum observed serum concentration (Cmax)	Day1-71

Secondary Outcome Measures

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