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OpenTrials
Completed

NCT Number: NCT01344863

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

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Christchurch, New Zealand

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

trastuzumab [Herceptin]

Drug

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

Primary outcomes

  1. Area under plasma concentration curve of trastuzumab

    Time frame: 21 days

  2. Maximum observed plasma concentration of trastuzumab

    Time frame: 21 days

Secondary outcomes

  1. Plasma concentration of trastuzumab

    Time frame: Day 21

  2. Safety: Incidence of adverse events

    Time frame: 21 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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)

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 29, 2011
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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