Clinical trial: Study to Assess the Safety, Tolerability, and Pharmacokinetics of E2730 (NCT03054194)

Eligibility criteria:
Inclusion Criteria:

          -  Non-smoking, male or female, age ≥18 years and ≤55 years old at the time of informed
             consent (note: to be considered non-smokers, participants must have discontinued
             smoking for at least 4 weeks before dosing)

          -  Body mass index (BMI) ≥18 and <32 kilograms per meters squared (kg/m^2) at Screening

        Exclusion Criteria:

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

          -  Females who are breastfeeding or pregnant at Screening or Baseline (documented by a
             negative beta human chorionic gonadotropin [β-hCG] (or human chorionic gonadotropin
             [hCG]) test with a minimum sensitivity of 25 International Units per Liter [IU/L] or
             equivalent units of β-hCG [or hCG]). A negative urine pregnancy test is required
             before the administration of the first dose per cohort.

          -  Females of childbearing potential who:

               -  Had unprotected sexual intercourse within 30 days before study entry and do not
                  agree to use a highly effective method of contraception (eg, total abstinence, an
                  intrauterine device, a double barrier method [such as condom plus diaphragm with
                  spermicide] or have a vasectomized partner with confirmed azoospermia but
                  hormonal contraceptives are not permitted) throughout the entire study period and
                  for 28 days after study drug discontinuation

               -  Are currently abstinent, and do not agree to use a double barrier method (as
                  described above) or refrain from sexual activity during the study period or for
                  28 days after study drug discontinuation

        NOTE: All females will be considered to be of childbearing potential unless they are
        postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age
        group, and without other known or suspected cause) or have been sterilized surgically (ie,
        bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery
        at least 1 month before dosing).

          -  Males who have not had a successful vasectomy (confirmed azoospermia) or they and
             their female partners do not meet the criteria above (ie, not of childbearing
             potential or practicing highly effective contraception throughout the study period or
             for 28 days after study drug discontinuation). No sperm donation is allowed during the
             study period or for 3 months after study drug discontinuation.

          -  Evidence of disease that may influence the outcome of the study within 4 weeks before
             dosing (eg, 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)

          -  Any history of seizures, including those experienced in childhood

          -  Any history of gastrointestinal surgery that may affect pharmacokinetic profiles of
             E2730 (eg, hepatectomy, nephrectomy, digestive organ resection) at Screening

          -  Any clinically abnormal symptom or organ impairment found by medical history, physical
             examinations, vital signs, electrocardiogram (ECG) finding, or laboratory test results
             that require medical treatment at Screening or Baseline

          -  A prolonged QT/QT corrected (QTc) interval (QC interval corrected using Fridericia's
             formula [QTcF] >450 milliseconds) demonstrated on ECG at Screening or Baseline (based
             on average of triplicate ECGs). A history of risk factors for torsade de pointes (eg,
             heart failure, hypokalemia, family history of long QT Syndrome) or the use of
             concomitant medications that prolonged the QT/QTc interval

          -  Left bundle branch block at Screening or Baseline

          -  Persistent systolic blood pressure (BP) >130 or <100 millimeters of mercury (mmHg) or
             diastolic BP >85 or <50 mmHg at Screening or Baseline

          -  Persistent heart rate less than 50 beats/min or more than 100 beats/min at Screening
             or Baseline

          -  History of myocardial infarction, ischemic heart disease, or cardiac failure at
             Screening

          -  History of clinically significant arrhythmia or uncontrolled arrhythmia

          -  Known history of clinically significant drug allergy at Screening or Baseline

          -  Known history of food allergies or presently experiencing significant seasonal or
             perennial allergy at Screening or Baseline

          -  Known to be human immunodeficiency virus positive at Screening

          -  Active viral hepatitis (A, B, or C) as demonstrated by positive serology at Screening

          -  History of drug or alcohol dependency or abuse within the 2 years before Screening, or
             those who have a positive drug test (including cannabinoids) or alcohol test at
             Screening or Baseline

          -  Intake of caffeinated beverages or food within 72 hours before dosing

          -  Intake of nutritional supplements, juice, and herbal preparations or other foods or
             beverages that may affect the various drug-metabolizing enzymes and transporters (eg,
             alcohol, grapefruit, grapefruit juice, grapefruit-containing beverages, apple or
             orange juice, vegetables from the mustard green family [eg, kale, broccoli,
             watercress, collard greens, kohlrabi, Brussel's sprouts, mustard], and charbroiled
             meats) within 1 week before dosing

          -  Intake of herbal preparations containing St. John's Wort within 4 weeks before dosing

          -  Use of prescription drugs within 4 weeks before dosing

          -  Intake of over-the-counter (OTC) medications within 2 weeks before dosing

          -  Currently enrolled in another clinical study or used any investigational drug or
             device within 30 days or 5 half-lives, whichever is longer, preceding informed consent

          -  Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or
             donation of plasma within 1 week of dosing

          -  Engagement in strenuous exercise within 2 weeks before check-in (eg, marathon runners,
             weight lifters)
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 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