Comparison between two injectable formulations of anti- cancer drug Pertuzumab by studying their blood levels and safety in healthy adult male subjects
- Registration Number
- CTRI/2023/06/054259
- Lead Sponsor
- CinnaGen Research and Production Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
1 Healthy male human subjects, age in the range of 18 – 45 years both inclusive
2 Body Mass Index between 18.5-30 Kg / m2 extremes included and Body weight is at least 50 kg
3 Subjects with normal findings as determined by baseline history, physical examination and vital sign examination (blood pressure, pulse rate, respiration rate and body temperature).
4 Subjects with clinically acceptable findings as determined by haemogram, biochemistry, urinalysis, 12 lead ECG and chest X-ray (if done).
5 Willingness to follow the protocol requirements especially abstaining from xanthine containing food or beverages (chocolates, tea, coffee or cola drinks) or grapefruit juice, any alcoholic products, the use of cigarettes and the use of tobacco products for 48.00 hours prior to dosing until after the last blood sample collection in the study and adherence to food, fluid and posture restrictions.
6 Subjects willing to sign Informed Consent Form.
7 Subjects with Left ventricular ejection fraction (LVEF) = 55 %.
8 Ability to comply with study and follow-up procedures.
9 Subjects who have no evidence of underlying disease during screening medical history.
10 No history of significant alcoholism.
11 No history of drug abuse (benzodiazepines and barbiturates) for the last one month and other illegal drugs (Appendix B) for the last 06 months.
12 Non-smokers, ex-smokers and moderate smokers will be included. Moderate smokers are defined as someone smoking 10 cigarettes or less per day, ex-smokers are someone who completely stopped smoking for at least 3 months. ?
1 Known history of hypersensitivity to Pertuzumab or any of the excipients and/or related drugs.
2 Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
3 Subjects who have taken prescription medications or over-the-counter products (excluding vitamins, mineral supplements, and dietary supplements) within 28 days prior to administration of IMP.
4 Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood–forming organs, use of monoclonal antibody etc.
5 History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
6 Participation in a clinical drug study or bioequivalence study 90 days prior to dosing of the present study.
7 History of malignancy or other serious diseases.
8 Blood donation 90 days prior to dosing of the present study.
9 Subjects with positive HIV tests, HBsAg or Hepatitis-C tests.
10 Subjects with any other medical or psychiatric condition that could compromise study participation.
11 Found positive in breath alcohol test.
12 Found positive in urine test for drug abuse.
13 Any contraindication to blood sampling.
14 Male subjects not confirming to using birth control measures, from the date of screening until the completion of the study. Abstinence, barrier methods (condom etc.) are acceptable.
15 Major surgery or trauma within past one year of screening or anticipated need for any surgery during the study.
16 Any other condition or circumstance that, in the judgment of the Investigator, might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate pharmacokinetic characteristics of two formulations of PertuzumabTimepoint: Pre dose (collected within 01.00 hour prior to dosing), 60 min (prior to end of infusion) & at 02.00, 03.00, 06.00, & 12.00 hours post-dose, Day 2, 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85 post dose
- Secondary Outcome Measures
Name Time Method To evaluate the safety parameters of two formulations of PertuzumabTimepoint: Well-being assessment, blood pressure & pulse rate at 01.00, 03.00, 05.00, 08.00, 12.00 and 24.00 hrs ± 45 minutes of scheduled time.