Clinical trial NCT02100917: Bioequivalence Study Evaluating the Pharmacokinetics of DMB-3111 and Trastuzumab in Healthy Japanese Male Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Bioequivalence
Biosimilarity
Similarity
Pharmacokinetics
Phase I
Trastuzumab
Healthy Male Volunteers
Single-dose
HER-2
Oncology
Lead sponsor: Meiji Seika Pharma Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Dong-A Pharmaceutical
First posted: 2014-04-01
Enrollment: 70
Sex: MALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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


Eligibility criteria: 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

Primary outcomes:
measure: Area Under the Concentration-Time (AUC)
timeFrame: Day1-71
measure: Maximum observed serum concentration (Cmax)
timeFrame: Day1-71
Secondary outcomes:
measure: Area under the concentration-time curve (AUC) from 0 to time of the last measurable concentration
timeFrame: Day1-71
measure: Area under the concentration-time curve (AUC) from 0 to infinity
timeFrame: Day1-71
measure: Time to reach the peak concentration (tmax)
timeFrame: Day1-71
measure: Mean residence time (MRT) from 0 to final sampling time point
timeFrame: Day1-71
measure: Mean residence time (MRT) from 0 to infinity
timeFrame: Day1-71
measure: elimination rate constant (kel)
timeFrame: Day1-71
measure: Elimination half life (t1/2)
timeFrame: Day1-71
measure: Clearance (CL)
timeFrame: Day1-71
measure: Incidence of adverse events
timeFrame: Day1-71
Other outcomes:
measure: Incidence of anti-trastuzumab antibodies (ADAs)
timeFrame: Day1-71
Locations:
city: Fukuoka
country: Japan
Study officials:
References:
citation: Morita J, Tanaka M, Nomoto M, Matsuki S, Tsuru T, Matsuguma K, Shiramoto M. Pharmacokinetic Bioequivalence, Safety, and Immunogenicity of DMB-3111, a Trastuzumab Biosimilar, and Trastuzumab in Healthy Japanese Adult Males: Results of a Randomized Trial. BioDrugs. 2016 Feb;30(1):17-25. doi: 10.1007/s40259-015-0153-2.