multiple myeloma
Conditions
Interventions
A?:T / R
B?:R / T
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following inclusion criteria will be enrolled in this study: 1) Healthy male subjects aged 18 - 45 years (inclusive); 2) Body weight of no less than 50 kg, and BMI (Body mass index (BMI) = weight (kg) / body height2(m2) within the range of 19-26 (inclusive); 3) Subjects who will take an appropriate form of birth control during the study and within 28 days after the last dose of pomalidomide (e.g. Latex or synthetic condoms must be used during sex contact with women of childbearing potential during the study and until 28 days after the last dose of pomalidomide, even if he has successfully undergone a vasectomy); 4) No sperm donation is allowed during the study and until 28 days after the last dose of pomalidomide; 5) No blood donation is allowed during the study and until 1 month after the last dose of pomalidomide; 6) Subjects who sign the informed consent form before screening, and fully understand the study content, procedures and possible adverse reactions; 7) Capable of completing the study as required by the protocol
Exclusion criteria
Exclusion criteria: Subjects who satisfy any one of the following criteria will be ineligible for enrollment: 1) Any prior or current clinically significant disorders in circulation system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry or metabolism or any other disease which can interfere with the test results; 2) Subjects who have underwent surgery within 1 month prior to the screening, or have a surgery scheduled to be performed during the study; 3) Have received or plan to receive active or attenuated vaccines within the first month prior to screening, or have infectious diseases such as varicella, mumps or measles; 4) History of allergy to thalidomide, lenalidomide or pomalidomide; 5) Have received prescription drugs, over the counter drugs, vitamin products, or herbal medicines within 14 days prior to the first dose (drugs that have no effect on metabolic process of pomalidomide and have no interaction with pomalidomide are allowed); 6) Have received pomalidomide within 3 months prior to the first dose, or have participated in other drug clinical trials; 7) Blood donation or massive blood loss (> 400 mL) within 3 months prior to the screening 8) Drinking excessive tea, coffee and/or caffeine-containing beverages (more than 8 cups, 1 cup = 250 mL) every day; 9) Heavy smoker, or smoking more than 5 cigarettes per day within 3 months prior to the screening, or inability to give up smoking throughout the hospitalization; 10) Alcoholism within 3 months prior to the screening (alcohol craving: more than 14 units of alcohol per week on average (1 unit = 360 mL beer or 45 mL liquor containing 40% alcohol or 150 mL wine)); 11) Drug abuser or use of soft drugs within 3 months prior to the screening (e.g.: marijuana) or use of hard drugs within 1 year prior to screening (e.g.: cocaine, phencyclidine, etc.); 12) Subjects who have special requirements for diet, or inability to comply with the uniform diet schedule; 13) History of fear of needles or homophobia, or known serious hemorrhagic factors that affect venous blood collection; 14) History of dysphagia; 15) Subjects who drive vehicles, operate machines, or perform dangerous tasks as their career; 16) Clinically significant abnormal findings in vital signs, physical examination, electrocardiogram or laboratory tests (as determined by the physician); 17) Alcohol screen positive or drug abuse positive; 18) Have consumed any xanthine-containing food or drinks (such as chocolate, tea, coffee and cola, etc.) within 48 hours prior to the first dose; 19) Have consumed grapefruit or pomelo, or products containing ingredients of grapefruit or pomelo (grapefruit juice, pomelo juice, etc.) 48 hours prior to the first dose; 20) Subjects who, in the opinion of the investigator, are considered as not suitable for participation in the study (inability to understand and comply with study requirements, or due to safety concerns).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentration of permalidomide; | — |
Countries
China
Contacts
Public ContactGuoping Yang
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed