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

Healthy Volunteer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01344863
• Other study ID #: BO25532
• Status: Completed
• Phase: Phase 1
• First received: April 28, 2011
• Last updated: November 1, 2016
• Start date: April 2011
• Est. completion date: January 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• trastuzumab [Herceptin]
600 mg subcutaneously using a single-use injection device on Day 1
• trastuzumab [Herceptin]
600 mg subcutaneously using a handheld syringe on Day 1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under plasma concentration curve of trastuzumab		21 days	No
Primary	Maximum observed plasma concentration of trastuzumab		21 days	No
Secondary	Plasma concentration of trastuzumab		Day 21	No
Secondary	Safety: Incidence of adverse events		21 weeks	No