Clinical trial: An Study to Determine the Bioavailability of E2609 Tablets Compared to Capsules and the Effect of Food on Absorption (NCT01716897)

Eligibility criteria:
Inclusion Criteria

          1. Caucasian males defined as persons of a European or Latin American descent

          2. Healthy male 30 to 55 years inclusive at the time of informed consent

          3. Body mass index (BMI) of 18 to 32 kg/m2 at Screening

          4. Subjects must have had a successful vasectomy (confirmed azoospermia), or they and
             their female partners must not be of childbearing potential or must be practicing
             highly effective contraception throughout the study period and for 30 days after study
             drug discontinuation. No sperm donation is allowed during the study period and for 30
             days after study drug discontinuation.

        Exclusion Criteria

          1. Any history of seizures or epilepsy (not including a history of simple febrile
             seizures in childhood) or disturbance of consciousness likely to be due to seizures

          2. Any medical condition which, in the opinion of the investigator has high risk of
             seizures (e.g., history of traumatic brain injury associated with loss of
             consciousness or amnesia, alcohol abuse, substance abuse) at Screening or within past
             5 years

          3. Any history of cerebrovascular disease (stroke or transient ischemic attack)

          4. A history of prolonged QT/QTc interval or prolonged period from the beginning of the
             QRS complex to the end of the T wave on an ECG (QT)/ QT corrected for heart rate using
             Fridericia?s formula (QTcF) interval (QTcF &gt; 450 ms) as demonstrated by the mean of
             triplicate electrocardiogram (ECGs) (recorded at least 1 min apart) at Screening or
             Baseline Period

          5. Any other clinically significant ECG abnormalities at Screening or Baseline Periods,
             e.g. component of the ECG cycle from onset of atrial depolarization to onset of
             ventricular depolarization (PR)&gt;220 ms, component of ECG wave representing
             ventricular depolarization (QRS)&gt;110 ms

          6. Hypersensitivity to the study drugs or any of their excipients
Male
Accepts Healthy Volunteers
Subject must be at least 30 Years old.
Subject must be at most 55 Years

Patient description (medical language): A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia.  The patient is sexually active with his wife and does not use any contraception methods.  They have been trying to conceive for the past year with no success.  The patient has a past medical history of recurrent pneumonia, shortness of breath, and  persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol.  The patient has no history of other medical conditions including allergies or any kind of surgery.  On physical examination, the digits show clubbing.  An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test.

Patient description (patient's own words): I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test.

Does the patient match the trial criteria? Entailment