Clinical trial: A Study to Assess the Safety and Tolerability of E8001 in Healthy Male Participants (NCT04609852)

Eligibility criteria:
Inclusion Criteria

          1. Non-smoking, age greater than or equal to (>=) 20 years and less than or equal to (<=)
             55 years old adult male at the time of informed consent. To be considered non-smokers,
             participants must have discontinued smoking for at least 4 weeks before dosing

          2. Body mass index (BMI) >=18.5 and less than (<) 25.0 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 or for 5
             times the half-life of the study drug plus 90 days after study drug discontinuation).
             No sperm donation is allowed during the study period and for 5 times the half-life of
             the study drug plus 90 days after study drug discontinuation

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

          3. History of meningococcal infection or pneumococcal infection

          4. Evidence of disease that may influence the outcome of the study within 4 weeks before
             dosing; example- psychiatric disorders and disorders of the gastrointestinal tract,
             liver, kidney, respiratory system, endocrine system, hematological system,
             neurological system, or cardiovascular system, or participants who have a congenital
             abnormality in metabolism

          5. Any history of gastrointestinal surgery that may affect PK profiles of E8001, example-
             hepatectomy, nephrectomy, and digestive organ resection at Screening

          6. Any clinically abnormal symptom or organ impairment found by medical history at
             Screening, and physical examinations, vital signs, ECG finding, or laboratory test
             results that require medical treatment at Screening or Baseline

          7. History of prolonged QT/QTc interval

          8. History of left bundle branch block (LBBB)

          9. History of myocardial infarction (MI) or active ischemic heart disease (IHD)

         10. History of clinically significant arrhythmia or uncontrolled arrhythmia

         11. Active viral hepatitis (A, B or C) and syphilis as demonstrated by positive serology
             at Screening

         12. History of drug or alcohol dependency or abuse, or those who have a positive drug test
             at Screening or Baseline
Male
Accepts Healthy Volunteers
Subject must be at least 20 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