Clinical trial: A Study to Assess the Relative Bioavailability of JNJ64041575 Administered as 2 Different New Concept Formulations (Oral Suspension and Tablet) Compared to Their Respective Current Formulations, and to Assess the Effect of Food on the Pharmacokinetics of the 2 New Concept Formulations (NCT03010059)

Eligibility criteria:
Inclusion Criteria:

          -  Participant must have a body mass index (BMI; weight in kg divided by the square of
             height in meters) between 18.0 and 30.0 kilogram per square meter kg/m^2, extremes
             included, and a body weight not less than 50.0 kg, extremes included

          -  Participant must have a normal 12-lead electrocardiogram (ECG) consistent with normal
             cardiac conduction and function at screening, including: a) normal sinus rhythm (heart
             rate between 45 and 100 beats per minute [bpm], extremes included); b) QT corrected
             according to Fridericia's formula (QTcF) interval less than or equal to (<=)430
             milliseconds (ms) for male participants and <=450 ms for female participants; c) QRS
             interval <=110 ms; d) PR interval <=200 ms; e) ECG morphology consistent with healthy
             cardiac conduction and function. Any evidence of heart block, or of left or right
             bundle branch block is exclusionary

          -  Participants must have normal values for alanine aminotransferase (ALT) and aspartate
             aminotransferase (AST) (less than or equal (<=)1.0×upper limit of laboratory normal
             range [ULN])

          -  Contraceptive use by female participants should be consistent with local regulations
             regarding the use of contraceptive methods for participants participating in clinical
             studies. Before randomization, a woman must be either: a) Not of childbearing
             potential defined as: 1) Postmenopausal: A postmenopausal state is defined as greater
             than (>)45 years and no menses for 12 consecutive months without an alternative
             medical cause and a serum follicle stimulating hormone (FSH) level in the
             postmenopausal range (>40 International units per liter [IU/L] or milli-international
             units per milliliter [mIU/mL]), OR; 2) Permanently sterile: Permanent sterilization
             methods include hysterectomy, bilateral salpingectomy, bilateral tubal
             occlusion/ligation procedures (without reversal operation), and bilateral oophorectomy
             b) Of childbearing potential and, if heterosexually active, 1) Practicing a highly
             effective method of contraception (failure rate of less than (<)1percent (%) per year
             when used consistently and correctly) 2) Agrees to remain on a highly effective method
             throughout the study and for at least 44 days after the last dose of study drug

          -  A female participant, except if postmenopausal, must have a negative serum beta human
             chorionic gonadotropin (beta- hCG) pregnancy test at screening, and a negative urine
             pregnancy test on Day 1 in each treatment period

          -  Participant must be able to taste and smell normally, to their own opinion.
             Participants who have an impaired sense of taste and/or smell due to any conditions
             such as allergic rhinitis, common cold, or sinusitis are not eligible to take part in
             the study

        Exclusion Criteria:

          -  Participant has a mouth pathology including, but not limited to, pain, ulcer, edema,
             mucosal erosion, gingivitis and/or (dental) abscesses, or receives treatment for oral
             pathologies (eg, antifungals or antibiotics) or oral treatment for any disease

          -  Participant with a history of clinically significant drug allergy such as, but not
             limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous
             studies with experimental drugs

          -  Participant is hepatitis B surface antigen (HBsAg) positive or hepatitis C virus (HCV)
             antibody positive with HCV RNA positive, or has another clinically active liver
             disease at screening

          -  Participant has a history of human immunodeficiency virus type 1 (HIV-1) or HIV 2
             antibody positive, or tests positive for HIV-1 or -2 at screening

          -  Participant has previously been dosed with JNJ-64041575 in more than 3 single-dose
             studies with JNJ-64041575 or has previously been dosed with JNJ-64041575 in a
             multiple-dose study with JNJ-64041575

          -  Participants with 1 or more of the following laboratory abnormalities at screening as
             defined by the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity
             Table a) Serum creatinine grade 1 or greater (greater [>]1.0* upper limit of
             laboratory normal range [ULN]) b) Hemoglobin grade 1 or greater (<=10.5 gram per
             decilitre [g/dL]) c) Platelet count grade 1 or greater (<=99.999/millimeter [mm]^3) d)
             Reticulocyte count (absolute) below the lower limit of laboratory normal range (LLN)
             e) Absolute neutrophil count grade 1 or greater (<=1,500/mm^3) f) Total bilirubin
             grade 1 or greater (>1.0*ULN) g) Any other toxicity grade 2 or above, except for grade
             2 elevations of low density lipoprotein (LDL) cholesterol and/or cholesterol
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 24-year-old man comes to the office complaining of infertility.  He and his wife have been trying to conceive for the last 18 months.  Medical records of his wife showed no abnormalities.  The patient doesn't smoke and takes no medications.  Height is 185 cm and weight is 77 kg.  Heart and lung sounds are normal.  There is bilateral gynecomastia and bilateral descended firm testes.  The lower extremities appear abnormally long. His karyotype evaluation shows 47, XXY consistent with Klinefelter syndrome.

Patient description (patient's own words): I'm only a 24 year old man but I’m already struggling with infertility. I went to a clinic with my wife the other day because we've been trying to have a baby for at least 18 months. The medical records of my wife are totally normal. For me I don't smoke or take any medication. I'm 185 cm and 77 kg. Everything was normal when the doctor inspected my lungs and my heart. The doctor said that I have enlarged breasts for a man. My testicles seem normal. The doctor noticed that my legs were abnormally long compared to the rest of my body. I also had a karyotype evaluation which led the doctor to diagnose me with Klinefelter syndrome.

Does the patient match the trial criteria? Contradiction