Clinical trial: A Study of Seltorexant (JNJ-42847922) After Single-Dose Administration in Healthy Participants (NCT03682380)

Eligibility criteria:
Inclusion Criteria:

          -  Be healthy on the basis of medical history (screening only), physical examination,
             vital signs, and 12-lead electrocardiogram (ECG) performed at screening and Day 1
             (predose)

          -  Be healthy on the basis of clinical laboratory tests performed at screening. If the
             results of the serum chemistry panel, 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. This
             determination must be recorded in the participant's source documents and initialed by
             the investigator

          -  All female participants (regardless of childbearing potential), must have a negative
             serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a
             negative urine pregnancy test on Day -1 of each treatment period

          -  A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted
             reproduction during the study and for at least 1 month after the last study drug
             administration

          -  A man, who is sexually active with a woman of childbearing potential and has not had a
             vasectomy, must agree to use an adequate contraception method as deemed appropriate by
             the investigator (for example, abstinence, vasectomy, barrier method, partner using
             effective contraception)

        Exclusion Criteria:

          -  History of or current clinically significant medical illness including (but not
             limited to) cardiac arrhythmias or other cardiac disease, hematologic disease,
             coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid
             abnormalities, significant pulmonary disease, including bronchospastic respiratory
             disease, diabetes mellitus, hepatic (Child-Pugh Score greater than or equal to [>=] 7)
             or renal insufficiency (estimated glomerular filtration rate [eGFR] less than [<] 60
             milliliter per minute per 1.73 meter square [mL/min/1.73m^2] based on the modified
             diet renal disease [MDRD] formula at screening only), thyroid disease, neurologic
             (including seizure disorders) or psychiatric disease (depression or anxiety disorder
             in remission is acceptable), infection, or any other illness that the investigator
             considers should exclude the participant or that could interfere with the
             interpretation of the study results. Significant past gastrointestinal medical
             history, or any disease/surgery that would with interfere drug absorption

          -  Clinically significant abnormal values for hematology, clinical chemistry (including
             thyroid stimulating hormone [TSH] at screening only) or urinalysis at screening or at
             admission to the study site. It is expected that laboratory values will generally be
             within the normal range for the laboratory, though minor deviations, which are not
             considered to be of clinical significance to the investigator, are acceptable

          -  Clinically significant abnormal physical examination, vital signs, or 12-lead ECG at
             screening or at admission to the study site though minor deviations, which are not
             considered to be of clinical significance to the investigator are acceptable

          -  Use of any prescription or nonprescription medication (including vitamins and herbal
             supplements), except for acetaminophen, oral contraceptives, and hormonal replacement
             therapy within 14 days before the first dose of the study drug is scheduled. Or has
             used any systemic herbal medications or dietary supplements including products
             containing Hypericum perforatum (for example, St. John's Wort) from 21 days before the
             first dose of study drug is scheduled

          -  Received a known inhibitor of Cytochrome P450 3A4 (CYP3A4) or CYP2C9 activity within
             14 days or a period less than 5 times the drugs half-life; whichever is longer, before
             the first dose of the study drug is scheduled
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 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? Contradiction