A Randomized, Single-Blind, Single-Dose, 3-Arm, Parallel Group Study to Determine the Pharmacokinetic Equivalence of ABP 980 and Trastuzumab (Herceptin "(Registered Trademark)" ) in Healthy Male Subjects
Amgen Inc, USA.
150 participants
May 26, 2014
Interventional
Conditions
Summary
The study is evaluating the safety, tolerability, and immunogenicity of ABP 980 in healthy subjects compared with US Food and Drug Administration (FDA)-licensed trastuzumab and European Union (EU)-authorized trastuzumab. Who is it for? You may be eligible to join this study if you are healthy male, aged between 18 to 45 years of age (inclusive), and have a body mass index between 18.0 and 30.0 kg/m2 (inclusive) for non-Japanese subjects. To be enrolled as a Japanese subject, subjects must be either first- or second-generation Japanese and have a body mass index between 18.0 and 25.0 kg/m2. Trial details Participants in this study will be randomly (by chance) divided into one of three groups. Participants in one group will receive 6mg/kg of ABP 980 (440mg vial) intravenously once only. Participants in the second group will receive 6mg/kg2 of FDA-licensed trastuzumab (440mg vial) intravenously. Participants in the third group will receive 6mg/kg2 of EU-authorised trastuzumab (440mg vial) intravenously. All participants will be followed-up at 64 days post allocation to one of the three drugs used in this trial. Address: Nucleus Network Limited Centre for Clinical Studies (AMREP site) Level 5 Burnet Building 89 Commercial Road, Melbourne, Victoria 3004
Eligibility
Inclusion Criteria10
- Subjects must sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form (ICF) before any study-specific procedures are performed.
- Healthy adult men between 18 to 45 years of age, inclusive.
- Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, for non-Japanese subjects. A BMI between 18.0 and 25.0 kg/m2, inclusive, for Japanese subjects. BMI = weight (kg)/(height [m])2
- Normal or clinically acceptable physical examination, clinical laboratory test values, vital signs, echocardiogram, and electrocardiograms (ECGs; 12-lead ECG reporting heart rate and RR, PR, QRS, QT, and QTcF intervals) at screening (physical examination, ECGs, and vital signs will be repeated on Day -1).
- Subjects must be able to communicate effectively with the study personnel.
- To be enrolled as a Japanese subject, subjects must be either first- or second-generation
- Japanese:
- First-generation Japanese are subjects who may be living outside of Japan but were born in Japan to parents of Japanese descent;
- Second-generation Japanese are subjects who were born outside of Japan to
- first-generation Japanese parents.
Exclusion Criteria10
- Men of reproductive potential (ie, men who have not had a vasectomy), unwilling to practice a highly effective method of birth control for the duration of the study and continuing 5 months following treatment with investigational product. Highly effective methods of birth control include:
- a. sexual abstinence;
- b. vasectomy or a condom (men) in combination with either barrier methods, hormonal birth control, or intrauterine device (utilized by female partners).
- Men who are unwilling to refrain from donating sperm during the study and for 5 months following treatment with investigational product.
- Men with pregnant partners.
- History or evidence of a clinically significant disorder (including psychiatric), condition, or disease that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
- History or presence of conditions known to interfere with the distribution, metabolism, or excretion of drugs.
- History of surgery or major trauma within 12 weeks of screening, or surgery planned during the study.
- Positive screen for alcohol and/or potential drugs of abuse at screening or prior to randomization.
- Positive screen for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg), or hepatitis C virus (HCV).
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Arm 1: ABP 980 6 mg/kg (440 mg vial) Arm 2: trastuzumab 6 mg/kg (FDA-licensed 440 mg vial) Arm 3: trastuzumab 6 mg/kg (EU-authorized; 150 mg vial) Subjects will be randomized to receive intravenous infusion of ABP 980 6 mg/kg (Treatment Arm 1), trastuzumab 6 mg/kg (FDA-licensed; Treatment Arm 2), or trastuzumab 6 mg/kg (EU-authorized; Treatment Arm 3) in a ratio of 1:1:1 stratified by ethnicity (Japanese versus non-Japanese). Subjects will only be dosed once, on the morning of Day 1 over 90 minutes after breakfast. Weight from Day -1 will be used to calculate dose.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12614000400662