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A Study of Administration of Trastuzumab (Herceptin) by a Single-use Injection Device Versus a Handheld Syringe

NCT ID: NCT01344863

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

trastuzumab [Herceptin]

Intervention Type DRUG

600 mg subcutaneously using a single-use injection device on Day 1

2

Group Type ACTIVE_COMPARATOR

trastuzumab [Herceptin]

Intervention Type DRUG

600 mg subcutaneously using a handheld syringe on Day 1

Interventions

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trastuzumab [Herceptin]

600 mg subcutaneously using a single-use injection device on Day 1

Intervention Type DRUG

trastuzumab [Herceptin]

600 mg subcutaneously using a handheld syringe on Day 1

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Christchurch, , New Zealand

Site Status

Grafton, , New Zealand

Site Status

Countries

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New Zealand

References

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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.

Reference Type DERIVED
PMID: 24057039 (View on PubMed)

Other Identifiers

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BO25532

Identifier Type: -

Identifier Source: org_study_id