Breast cancer
Conditions
Interventions
FTMB, Herceptin or placebo (infusion).
Sponsors
Synthon BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy males, 18-45 years of age Body Mass Index (BMI) 18.5 to 30.0 kg/m2, inclusive; Subject is available for the entire study period and will provide his written informed consent; Physical examination without significant deviations; Vital signs, Electro Cardiogram (ECG) and Echo Cardiogram (Echo) without significant deviations; All laboratory screening results within the normal range or being assessed as non-significant by the attending physician. Baseline LVEF > 55%.
Exclusion criteria
Exclusion criteria: History and/or current presence of hypersensitivity or allergic reactions, spontaneous or following a drug administration; History and/or current presence of cardiac conditions, or any abnormal echo cardiogram finding (e.g. regional wall motion abnormality or signs of hypertrophic cardiomyopathy); History and/or current presence of significant gastrointestinal, renal, hepatic, cardiovascular or pulmonary disease; Clinically significant illness within four weeks before study start; Any significant clinical abnormality, including a positive test for HBsAg, HCV, or HIV; Serious mental disease; Drug, alcohol, solvents or caffeine abuse; Smoking more than 10 cigarettes (or 2 cigars or 2 pipes) per day; Regular use of medication for at least three months; Use of organ-toxic drugs within three months before study start, or use of drugs with a well-defined potential for toxicity to a major organ or system (for example chloramphenicol, which may cause bone marrow suppression); Any systemic prescription treatment within 14 days before study start; Any systemic over-the-counter (OTC) drug treatment within 7 days before study start; Loss of blood outside the limits of Sanquin within 3 months prior to screening; Participation in another clinical trial within 3 months prior to the start of this study or more than 4 times a year; Positive test for drugs of abuse at screening; Any condition that in the opinion of the investigator could jeopardize the subject*s health and/or well-being.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK-profile: concentration - sampling at 0.75, 1.5, 2, 3, 4, 5, 6, 8, 24, 48, and 96 hours post dose, and 8, 14, 21, 28, 35, 42, 49, and 63 days post dose (to demonstrate bioequivalence). Safety and tolerability: general chemistry/haematology and urinalysis, cardiac markers, echocardiography, ECG, observation and questions, vital signs. | — |
Secondary
| Measure | Time frame |
|---|---|
| PK-profile: concentration - sampling at 0.75, 1.5, 2, 3, 4, 5, 6, 8, 24, 48, and 96 hours post dose, and 8, 14, 21, 28, 35, 42, 49, and 63 days post dose (to evaluate pharmacokinetic parameters). | — |
Countries
Netherlands
Outcome results
None listed