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: April 7, 2014
Last verified: April 2014
  Purpose

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
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
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: April 7, 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 April 17, 2014