The effects of Prasugrel on pharmacokinetics and pharmacodynamics of Edoxaban

JRCT ID: jRCTs071190006

Registered date:26/04/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Only healthy subjects
• Date of first enrollment: 28/05/2019
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Edoxaban administration, Prasugrel administration, bleeding time measurement

Outcome(s)

• Primary Outcome: Bleeding time
• Secondary Outcome: 1) Pharmacokinetic parameters of plasma edoxaban: Cmax,ss, AUCtau,ss, tmax,ss 2) Pharmacodynamic evaluation: Prothrombin time (PT), activated partial thromboplastin time (aPTT), prothrombin fragment F1+2 (F1+2), and platelet aggregation ability (PRU) 3) Safety assessment: adverse events, general blood biochemical clinical examinations, vital signs (body temperature, blood pressure, pulse rate), and 12 lead electrocardiogram

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: <= 80age old
• Gender: Male
• Include criteria: 1) Japanese elderly men 2) Gained written consent before the screening test 3) 65 years old or older, younger than 80 years old (at obtaining the informed consent) 4) Body weight is greater than 40 kg and 60 kg or less and whose BMI is 18.5 kg/m2 or more and less than 25.0 kg/m2 5) Quit smoking during the hospital stay

Exclude criteria

1) Person who judged by investigator etc. that research implementation is problematic in terms of ensuring safety because of disorders such as central nervous system, cardiovascular system, respiratory system, blood / hematopoietic function system, digestive system, liver / kidney function, thyroid function, pituitary function, adrenal function and the like or their past history. 2) Hypersensitivity or idiosyncrasy (Penicillin allergy etc.) to drug etc. 3) Alcohol or drug dependents 4) Positive for one or more of HBs antigen, syphilis test (RPR, TP antibody), HCV antibody, HIV antigen antibody in infectious disease test. 5) Confirmed positive findings in fecal occult blood test or urinary occult blood test. (at screening tests) 6) Bleeding diathesis (Easy to bleed from nasal mucosa or oral mucosa, etc.)(at screening tests) 7) Hemorrhagic diseases (intracranial hemorrhage, gastrointestinal bleeding, vitreous hemorrhage, retinal bleeding, hemoptysis, hematemesis, hematuria, bloody stools, hemorrhoids, hemorrhoid diseases, etc.)(tests at Screening and the time of hospitalization) 8) Has a family history (Up to the second degree of kinship of Direct family) of hereditary hemorrhagic disease. (Such as hemophilia, Von Willebrand disease, factor VII deficiency, factor X deficiency, factor XI deficiency, platelet dysfunction etc.)(at screening tests) 9) Bleeding time exceeds 9.5 minutes. However, excluding those who have judged that investigator etc. have no problem in participating in the research at the time of hospitalization tests. 10) Prothrombin time (PT) exceeding the facility reference value upper limit, or extension of activated partial thromboplastin time (aPTT). (tests at Screening and the time of hospitalization) 11) Received medical practice (including mental trauma, dental treatment by dentist) from other doctors within 14 days before hospitalization tests. However, excluding those who have judged that investigator etc. have no problem in participating in the research at the time of hospitalization tests. 12) Surgery is planned during the research period. (at screening tests) 13) One of the following.
More than 800 mL of whole blood was collected within 1 year before a screening tests. More than 400 mL of whole blood was collected within 84 days before a screening tests. More than 200 mL of whole blood was collected within 28 days before a screening tests. Blood component was collected within 14 days before a screening tests. Whole blood collection and component blood collection after the screening test (Blood collection done in this research, or excluding cases where investigetor etc. deems it necessary). 14) Participated in other research within 120 days prior to the screening tests and took study drugs. 15) A person who took or ingested an inhibitor or inducer of the drug metabolizing enzyme CYP3A4, or inhibitor of P-glycoprotein ithin 30 days before administration of the study drug or a person who intends to take it or intake it. (tests at Screening and the time of hospitalization) 16) Used other medicine within 7 days before hospitalization tests. 17) Ingested citrus fruits and their processed products within 7 days before hospitalization tests. 18) Laboratory test value deviates from the standard value of the medical institution, Abnormalities in electrocardiogram examination or There are clinically problematic symptoms / findings. (tests at Screening and the time of hospitalization) 19) eGFR level is less than 60mL/min/1.73m2. (tests at Screening and the time of hospitalization) 20) In addition, those who judged that investigator etc. is inappropriate. (When it is expected that adherence to visit or medication is difficult)

Related Information

• Primary Sponsor: Ikushima Ippei
• Source(s) of Monetary Support: DAIICHI SANKYO COMPANY, LIMITED