Clinical trial: A Study to Investigate the Safety, Tolerability and Pharmacokinetics of RO6889678 and the Combination of RO6889678 With Ritonavir in Healthy Participants (NCT02321384)

Eligibility criteria:
Inclusion Criteria:

          -  Absence of evidence of any active or chronic disease following a detailed medical and
             surgical history, a complete physical examination including vital signs, 12-lead
             Electrocardiogram (ECG), hematology, blood chemistry, serology and urinalysis

          -  A Body Mass Index (BMI) between 18 to 30 kilograms per square meter (kg/m^2),
             inclusive

          -  Female participants must be either surgically sterile (by means of hysterectomy and/or
             bilateral oophorectomy) or post-menopausal for at least one year (defined as
             amenorrhea greater than or equal to [>/=] 12 consecutive months without another cause,
             and confirmed by follicle stimulating hormone level greater than [>] 35
             milli-international units per milliliter [mIU/mL])

          -  Male participants must agree to use two adequate methods of contraception with their
             female partners of childbearing potential, including a barrier method during the
             treatment period and for at least 2 months after the last dose of study drug

        Exclusion Criteria:

          -  History or symptoms of any significant disease

          -  Pregnant or lactating

          -  Personal or family history of congenital long QT syndrome or sudden death

          -  Significant acute infection, e.g. influenza, local infection, acute gastrointestinal
             symptoms or any other clinically significant illness within two weeks of dose
             administration

          -  Clinically relevant ECG abnormalities on screening ECG

          -  Participation in an investigational drug or device study within 90 days prior to
             screening

          -  Medical or social conditions that would potentially interfere with the participant's
             ability to comply with the study visit schedule or the study assessments
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 60 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? 0