Clinical trial: A Study to Assess the Safety and Tolerability of E2511 in Healthy Participants (NCT04547361)

Eligibility criteria:
Inclusion Criteria:

          1. Non-smoking, age greater than or equal to (>=) 18 years and less than (<) 55 years old
             adult male or female (Cohorts 1 - 6) or age >=65 years and less than or equal to (<=)
             85 years old elderly male or female (Cohort 7) at the time of informed consent

          2. Weight of at least 50 kilogram (kg) and body mass index >=18 and <30 kilogram per
             square meter (kg/m^2) at Screening

        Exclusion Criteria:

          1. Males who have not had a successful vasectomy (confirmed azoospermia) or they and
             their female partners do not meet the criteria (that is, not of childbearing potential
             or practicing highly effective contraception throughout the study period plus 90 days
             after study drug discontinuation). No sperm donation is allowed during the study
             period plus 90 days after discharge from the study.

          2. Females who are breastfeeding or pregnant at Screening or Baseline

          3. Females of childbearing potential who:

               -  Within 28 days before study entry, did not use a highly effective method of
                  contraception,

               -  Do not agree to use a highly effective method of contraception (as described
                  above) throughout the entire study period and for 28 days after study drug
                  discontinuation.

          4. Clinically significant illness that requires medical treatment within 8 weeks or a
             clinically significant infection that requires medical treatment within 4 weeks of
             dosing

          5. Evidence of disease that may influence the outcome of the study within 4 weeks before
             dosing

          6. Evidence of disease related to chronic headaches, migraines, joint pain or other
             disorders or disease resulting in chronic or intermittent pain within 4 weeks before
             dosing

          7. Any personal or family history of seizures (including febrile seizures) or diagnosis
             of epilepsy or episode of unexplained loss of consciousness

          8. Any history of neurological or other medical conditions which in the opinion of the
             investigator has the potential to reduce seizure threshold

          9. Any epileptiform discharges in EEG at Screening

         10. A prolonged QT/ QT interval corrected for heart rate (QTc) interval >450 millisecond
             [ms]) A history of risk factors for torsade de pointes

         11. History of prolonged QT/QTc interval

         12. Left bundle branch block

         13. History of myocardial infarction or active ischemic heart disease

         14. History of clinically significant arrhythmia or uncontrolled arrhythmia

         15. Any lifetime history of suicidal ideation or any lifetime history of suicidal behavior
             as indicated by the C-SSRS

         16. Any lifetime history of psychiatric disease
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 85 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? Contradiction