Healthy VolunteerPhase 1NCT01344863
A Study of Administration of Trastuzumab (Herceptin) by a Single-use Injection Device Versus a Handheld Syringe
A Phase 1 study testing trastuzumab [Herceptin] in people with Healthy Volunteer, run by Hoffmann-La Roche at 2 sites in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- trastuzumab [Herceptin]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 2 sitesNew Zealand
- Study dates
- Apr 2011to Jan 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Volunteer
- Being tested
- trastuzumab [Herceptin]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trastuzumab [Herceptin]Drug
600 mg subcutaneously using a single-use injection device on Day 1
trastuzumab [Herceptin]Drug
600 mg subcutaneously using a handheld syringe on Day 1
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: trastuzumab [Herceptin] |
| 2 | Active comparator | Not described Receives: Drug: trastuzumab [Herceptin] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under plasma concentration curve of trastuzumab
Measured: 21 days
Maximum observed plasma concentration of trastuzumab
Measured: 21 days
Secondary outcomes (2)
Plasma concentration of trastuzumab
Measured: Day 21
Safety: Incidence of adverse events
Measured: 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344863
- Sponsor's protocol ID
- BO25532
- Status last verified
- Nov 2016
- First submitted
- 28 Apr 2011
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
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.
PubMed 24057039
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT01344863
- Acronym / sponsor ID
- BO25532
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 29 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: trastuzumab [Herceptin] |
| 2 | Active comparator | Drug: trastuzumab [Herceptin] |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trastuzumab [Herceptin]600 mg subcutaneously using a single-use injection device on Day 1 | Drug | 1 |
| trastuzumab [Herceptin]600 mg subcutaneously using a handheld syringe on Day 1 | Drug | 2 |
Primary outcome
Area under plasma concentration curve of trastuzumab
Time frame: 21 days
Maximum observed plasma concentration of trastuzumab
Time frame: 21 days
2 secondary outcomes
Plasma concentration of trastuzumab
Time frame: Day 21
Safety: Incidence of adverse events
Time frame: 21 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Derived from this study: PubMed 24057039Wynne 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.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing trastuzumab [Herceptin] in people with Healthy Volunteer, run by Hoffmann-La Roche at 2 sites in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under plasma concentration curve of trastuzumab (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01344863, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.