Clinical trial: A Single and Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of JNJ-42165279 in Healthy Japanese Male Participants (NCT03564379)

Eligibility criteria:
Inclusion Criteria:

          -  Healthy on the basis of clinical laboratory tests performed at screening and Day -1.
             If the results of the serum chemistry panel including liver enzymes, other specific
             tests, blood coagulation, hematology, or urinalysis are outside the normal reference
             ranges, the participant may be included only if the investigator judges the
             abnormalities or deviations from normal to be not clinically significant or to be
             appropriate and reasonable for the population under study. This determination must be
             recorded in the participant's source documents and initialed by the investigator

          -  Healthy on the basis of physical examination, medical history, vital signs, and
             12-lead electrocardiogram (ECG) performed at screening

          -  A man who is sexually active with a woman of childbearing potential, and has not had a
             vasectomy with confirmation of azoospermia, must agree to use a barrier method of
             birth control during the study and for 3 months after receiving the last dose of study
             drug, and his female partner must also use a highly effective form of birth control at
             least one month prior to the first study dose and continuing until 3 months after the
             final study dose. Acceptable barrier methods are male condoms with spermicide, and for
             the female partner a diaphragm or cervical cap with appropriate spermicidal foam,
             cream, or gel. Highly effective forms of birth control for the female partner are
             prescribed hormonal implants, contraceptive patches, contraceptive injections, oral
             contraceptives, and intrauterine device (IUD)

          -  Body Mass Index (BMI; weight/height^2 [kilogram per meter square {kg/m^2}]) between
             18.0 and 30.0 kg/m^2 (inclusive), and body weight not less than 50.0 kilogram (kg)

          -  Blood pressure (BP) (after the participant is standing for 3 minutes, supine for 5
             minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no
             higher than 90 mmHg diastolic (orthostatic cut-off, a fall in systolic BP of at least
             20 mmHg or diastolic BP of at least 10 mmHg when a person assumes a standing position
             is exclusionary). If BP is out of range, up to 2 repeated assessments are permitted

        Exclusion Criteria:

          -  Clinically significant abnormal values for hematology, clinical chemistry,
             coagulation, or urinalysis at screening (and at admission to the study center) as
             deemed appropriate by the investigator

          -  Known allergy, hypersensitivity, or intolerance to JNJ-42165279 or its excipients

          -  Any Grade 2 laboratory toxicity

          -  History of clinically significant drug and/or food allergies

          -  History of epilepsy or fits or unexplained black-outs
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? 1