Clinical trial: Study to Explore the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AHT956 in Healthy Subjects (NCT00410228)

Eligibility criteria:
Inclusion Criteria:

          -  Healthy male and female subjects age 18 to 45 years of age included, and in good
             health as determined by past medical history, physical examination, vital signs,
             electrocardiogram, and laboratory tests at screening.

          -  Vital signs must be within the following ranges: oral body temperature between
             35.0-37.5 °C; systolic blood pressure, 90-145 mm Hg; diastolic blood pressure, 50-95
             mm Hg; pulse rate, 40-90 bpm

          -  Female subjects must either:have been surgically sterilized or hysterectomized at last
             6 months prior to study participation with clinical documentation be postmenopausal
             (no regular menstrual bleeding for at least 1 year prior to study start)

          -  Body mass index must be within the range of 18 to 28 kg/m². Subjects must weigh at
             least 50 kg to participate in this study.

        Exclusion Criteria:

          -  Smokers (any subject who uses tobacco or has cotinine greater than 500 ng/mL)).

          -  Subjects who received live vaccine 4 weeks prior to dosing, any prescription drug use
             with 4 weeks prior to dosing, or over-the-counter medication use within 2 weeks prior
             to dosing.

          -  Participation in any clinical investigation within 4 weeks prior to dosing or longer
             if required by local regulations, and for any other limitation of participation based
             on local regulations.

          -  Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing, or
             longer if required by local regulation.

          -  Flu-like symptoms or significant within two weeks prior to dosing.

          -  A past medical history of clinically significant abnormality detected during
             electrocardiogram (ECG) examination or an evident family history (grandparents,
             parents and siblings) of a ECG abnormality (i.e. prolonged QT-interval syndrome).

          -  History of fainting, hypotension when standing up, arrhythmia.

          -  History of acute or chronic bronchospastic disease (including asthma and chronic
             obstructive pulmonary disease (including asthma and chronic obstructive pulmonary
             disease, treated or not treated).

          -  History of clinically significant drug allergy or history of atopic allergy,
             urticaria, eczematous dermatitis). A known hypersensitivity to the study drugs or
             drugs similar to the study drugs.

          -  Any history of surgical or medical condition(s) which could change the absorption,
             distribution, metabolism or excretion of drugs or which may jeopardize the subject,
             including history of gastrointestinal, pancreatic, liver, kidney, bladder, blood, or
             immune systems.

          -  History of drug or alcohol abuse within the 12 months prior to dosing or evidence of
             such abuse as indicated by the laboratory assays conducted the screening or baseline
             evaluations.

        Other protocol-defined inclusion/exclusion criteria may apply
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years

Patient description (medical language): A 20-year-old man comes to the emergency due to bleeding after a tooth extraction.  The bleeding has persisted for approximately 30 minutes despite constant direct pressure.  He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%.

Patient description (patient's own words): I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%.

Does the patient match the trial criteria? Contradiction