Text Size

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: June 3, 2013
Last verified: June 2013
History of Changes

April 28, 2011
June 3, 2013
April 2011
January 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01344863 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of Administration of Trastuzumab (Herceptin) by a Single-use Injection Device Versus a Handheld Syringe
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)

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Volunteer
  • Drug: trastuzumab [Herceptin]
    600 mg subcutaneously using a single-use injection device on Day 1
  • Drug: trastuzumab [Herceptin]
    600 mg subcutaneously using a handheld syringe on Day 1
  • Experimental: 1
    Intervention: Drug: trastuzumab [Herceptin]
  • Active Comparator: 2
    Intervention: Drug: trastuzumab [Herceptin]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
119
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
New Zealand
 
NCT01344863
BO25532
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP