- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01344863
A Study of Administration of Trastuzumab (Herceptin) by a Single-use Injection Device Versus a Handheld Syringe
November 1, 2016 updated by: Hoffmann-La Roche
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
119
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
-
-
-
Christchurch, New Zealand, 8011
-
Grafton, New Zealand, 1010
-
-
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
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
600 mg subcutaneously using a single-use injection device on Day 1
600 mg subcutaneously using a handheld syringe on Day 1
|
Active Comparator: 2
|
600 mg subcutaneously using a single-use injection device on Day 1
600 mg subcutaneously using a handheld syringe on Day 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under plasma concentration curve of trastuzumab
Time Frame: 21 days
|
21 days
|
Maximum observed plasma concentration of trastuzumab
Time Frame: 21 days
|
21 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma concentration of trastuzumab
Time Frame: Day 21
|
Day 21
|
Safety: Incidence of adverse events
Time Frame: 21 weeks
|
21 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
April 1, 2011
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
April 28, 2011
First Submitted That Met QC Criteria
April 28, 2011
First Posted (Estimate)
April 29, 2011
Study Record Updates
Last Update Posted (Estimate)
November 2, 2016
Last Update Submitted That Met QC Criteria
November 1, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BO25532
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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