This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: April 28, 2011
Last updated: November 1, 2016
Last verified: November 2016
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.

Condition Intervention Phase
Healthy Volunteer Drug: trastuzumab [Herceptin] Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Area under plasma concentration curve of trastuzumab [ Time Frame: 21 days ]
  • Maximum observed plasma concentration of trastuzumab [ Time Frame: 21 days ]

Secondary Outcome Measures:
  • Plasma concentration of trastuzumab [ Time Frame: Day 21 ]
  • Safety: Incidence of adverse events [ Time Frame: 21 weeks ]

Enrollment: 119
Study Start Date: April 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: trastuzumab [Herceptin]
600 mg subcutaneously using a single-use injection device on Day 1
Active Comparator: 2 Drug: trastuzumab [Herceptin]
600 mg subcutaneously using a handheld syringe on Day 1


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01344863

New Zealand
Christchurch, New Zealand, 8011
Grafton, New Zealand, 1010
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT01344863     History of Changes
Other Study ID Numbers: BO25532
Study First Received: April 28, 2011
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Antineoplastic Agents processed this record on August 16, 2017