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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01344863




Registration number
NCT01344863
Ethics application status
Date submitted
28/04/2011
Date registered
29/04/2011
Date last updated
2/11/2016

Titles & IDs
Public title
A Study of Administration of Trastuzumab (Herceptin) by a Single-use Injection Device Versus a Handheld Syringe
Scientific 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)
Secondary ID [1] 0 0
BO25532
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - trastuzumab [Herceptin]
Treatment: Drugs - trastuzumab [Herceptin]

Experimental: 1 -

Active Comparator: 2 -


Treatment: Drugs: trastuzumab [Herceptin]
600 mg subcutaneously using a single-use injection device on Day 1

Treatment: Drugs: trastuzumab [Herceptin]
600 mg subcutaneously using a handheld syringe on Day 1

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area under plasma concentration curve of trastuzumab
Timepoint [1] 0 0
21 days
Primary outcome [2] 0 0
Maximum observed plasma concentration of trastuzumab
Timepoint [2] 0 0
21 days
Secondary outcome [1] 0 0
Plasma concentration of trastuzumab
Timepoint [1] 0 0
Day 21
Secondary outcome [2] 0 0
Safety: Incidence of adverse events
Timepoint [2] 0 0
21 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
45 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch
Country [2] 0 0
New Zealand
State/province [2] 0 0
Grafton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT01344863
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications