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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01344863
First received: April 28, 2011
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This randomized, open-label, parallel, 2-arm, multicenter study will compare the administration of Herceptin (trastuzumab) with a single-use injection device ve rsus 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
Endpoint Classification: Pharmacokinetics Study
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 ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration of trastuzumab [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma concentration of trastuzumab [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 21 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT01344863

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

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01344863     History of Changes
Other Study ID Numbers: BO25532
Study First Received: April 28, 2011
Last Updated: August 4, 2014
Health Authority: New Zealand: Ministry of Health

Additional relevant MeSH terms:
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014