A Study of Administration of Trastuzumab (Herceptin) by a Single-use Injection Device Versus a Handheld Syringe
A Randomized, Open-label, 2-arm, Parallel Group, Single Dose, Multi-center Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of Trastuzumab Administered Subcutaneously as the Trastuzumab/rHuPH20 Formulation Using a Handheld Syringe or Using the Proprietary Single-use Injection Device (SID)
1 other identifier
interventional
119
1 country
2
Brief Summary
This randomized, open-label, parallel, 2-arm, multicenter study will compare the administration of Herceptin (trastuzumab) with a single-use injection device versus a handheld syringe in healthy male volunteers. The volunteers will receive a single dose of 600 mg Herceptin. The anticipated time of the study is 21 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 28, 2011
CompletedFirst Posted
Study publicly available on registry
April 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedNovember 2, 2016
November 1, 2016
9 months
April 28, 2011
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Area under plasma concentration curve of trastuzumab
21 days
Maximum observed plasma concentration of trastuzumab
21 days
Secondary Outcomes (2)
Plasma concentration of trastuzumab
Day 21
Safety: Incidence of adverse events
21 weeks
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Healthy male patients, 18 to 45 years of age, inclusive
- No history of hypersensitivity or allergic reactions following drug administration
- No history of clinically significant or clinically relevant cardiac condition
- No history of previous anticancer treatment
- Body mass index (BMI) between 18-32 kg/m2, inclusive
You may not qualify if:
- Positive test result for drugs of abuse
- Positive test result for hepatitis B, hepatitis C, or HIV 1 or 2
- Systolic blood pressure greater than 140 mmHG or less than 90 mmHG, or diastolic blood pressure greater than 90 mmHG or less than 50 mmHG
- Clinically significant abnormal laboratory values
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Christchurch, 8011, New Zealand
Unknown Facility
Grafton, 1010, New Zealand
Related Publications (1)
Wynne CJ, Ellis-Pegler RB, Waaka DS, Schwabe C, Lehle M, Heinzmann D, Mangat R, Li C, Dick AE, Cranshaw NA, Lum BL. Comparative pharmacokinetics of subcutaneous trastuzumab administered via handheld syringe or proprietary single-use injection device in healthy males. Cancer Chemother Pharmacol. 2013 Nov;72(5):1079-87. doi: 10.1007/s00280-013-2273-z. Epub 2013 Sep 22.
PMID: 24057039DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2011
First Posted
April 29, 2011
Study Start
April 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
November 2, 2016
Record last verified: 2016-11