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

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: trastuzumab [Herceptin]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01344863

BO25532

Details and patient eligibility

About

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.

Enrollment: 119 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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119 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: trastuzumab [Herceptin]

Drug: trastuzumab [Herceptin]

2

Active Comparator group

Treatment:

Drug: trastuzumab [Herceptin]

Drug: trastuzumab [Herceptin]