Clinical trial: A Study to Evaluate the Safety and Tolerability of YM150 in Healthy Caucasian and Japanese Male and Female Subjects, and to Assess the Effect That Gender May Have on Its Actions in the Body (NCT01655056)

Eligibility criteria:
Inclusion Criteria:

          -  Japanese subjects had to be born in Japan, have Japanese parents, have Japanese
             passports, have been resident in the West for no longer than 10 years or not at all
             and have a Japanese lifestyle (food habit)

        Caucasian subjects:

          -  Body weight:

               -  Males: 60-100 kg

               -  Females: 50-90 kg

          -  BMI: 18.0-27.0 kg/m2 (males and females)

        Japanese subjects:

          -  Body weight:

               -  Males: 50-80 kg

               -  Females: 40-70 kg

          -  BMI: 18.0-27.0 kg/m2 (males and females)

        Exclusion Criteria:

          -  Female subject of child-bearing potential, not practicing adequate methods to prevent
             pregnancies, like abstinence or double barrier methods (e.g. condom in combination
             with a spermicidal crème)

          -  Female subject showing a positive pregnancy test

          -  Lactating mother or woman with an intention of pregnancy

          -  Known or suspected hypersensitivity to YM150 or any of the constituents of the
             formulations used

          -  History of and/or any sign or symptom indicating current abnormal hemostasis or blood
             dyscrasia, including but not limited to neutropenia, thrombocytopenia,
             thrombocytopathy, thromboasthenia, hemophilia, Von Willebrand's disease, and vascular
             purpura, bleeding gums, or frequent nose bleeding

          -  Family history of congenital vascular malformation (e.g. Marfan's Syndrome) and/or
             bleeding disorder (e.g. hemophilia, Von Willebrand's disease, Christmas disease)

          -  History of peptic ulcer or of any other organic lesion susceptible to bleed

          -  PT or aPTT at the screening visit outside the normal range

          -  Any surgical intervention (including tooth extraction) or trauma within the last 3
             months preceding the initiation of the study

          -  Any clinically significant history of asthma, eczema, any other clinically significant
             allergic condition or previous severe hypersensitivity to any other drug

          -  Any clinically significant upper gastro-intestinal symptoms likely to interfere with
             the absorption of the drug

          -  History or presence of any cardiovascular disease or disorder

          -  History of a clinically significant ECG abnormality

          -  Any clinically relevant history of other disease or disorder - gastrointestinal,
             respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic

          -  Any clinically significant abnormality following the investigator's review of the
             pre-study physical examination, ECG, and clinical laboratory tests

          -  Abnormal heart rate and blood pressure measurements at the screening visit as follows:
             heart rate <40 or >90 bpm; mean systolic blood pressure <95 or >160 mmHg; mean
             diastolic blood pressure <40 or >95 mmHg (blood pressure measurements taken in
             triplicate after subject has been resting in supine position for 5 min)

          -  Regular use of any prescribed or OTC drugs in the 4 weeks prior to admission to the
             clinical unit OR any use of such drugs in the 2 weeks prior to admission to the
             clinical unit

          -  History of drug abuse at any time, OR any use of drugs of abuse within 3 months prior
             to admission to the clinical unit

          -  Participation in any clinical study within 3 months, or participation in more than 3
             clinical studies within 12 months, prior to the expected date of enrolment into the
             study

          -  History of drinking more than 21 units of alcohol per week (1 unit = 270 ml of beer or
             40 ml of spirits or 125 ml of wine) within 3 months prior to admission to the clinical
             unit

          -  History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day
             within 3 months prior to admission to the clinical unit

          -  Subject, who is anti-HAV (IgM), anti-HCV, HBsAg or HIV-1 or -2 positive

          -  Donation of blood (>400 ml) or blood products within 3 months prior to admission to
             the clinical unit or plasmapheresis within 4 weeks prior to admission to the clinical
             unit

          -  Employees of the Astellas Group or CRO involved in the study
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 55 Years

Patient description (medical language): A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction.  Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration.  The patient has heavy menstrual cycles each month.  She has no other medical problems and takes no medications.  Her mother and grandmother have also had excessive bleeding during menstrual period.  Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL.

Patient description (patient's own words): I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels.

Does the patient match the trial criteria? 0