Clinical trial: Phase Ib Study of Safety, Tolerability and Pharmacokinetics of Elpida Once Weekly in Healthy Volunteers (NCT03730311)

Eligibility criteria:
Inclusion Criteria:

          1. Healthy males or females aged between 18-40 years.

          2. Willing and able to complete all study procedures, visits and restrictions.

          3. Capable of giving written informed consent.

          4. Has been determined healthy by medical history, physical and vital signs examinations.

          5. Has normal results for the following screening tests: complete blood count (CBC),
             sodium, potassium, blood urea nitrogen (BUN), serum creatinine, fasting blood sugar
             (FBS), creatine kinase, total calcium, cholesterol, triglyceride, total protein, total
             bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline
             phosphatase (ALP) and urinalysis.

          6. Females of reproductive potential (defined as women who have not been postmenopausal
             for at least 24 consecutive months [i.e., who have had menses within the preceding 24
             months], or women who have not undergone surgical sterilization; specifically
             hysterectomy, salpingotomy, bilateral oophorectomy, and/or tubal ligation), must have
             a negative serum or urine pregnancy test with a sensitivity of at least 40 mIU/mL at
             Screening and prior to drug dosing on Day 1.

          7. All participants must agree not to participate in a conception process (e.g., active
             attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization).
             If participating in sexual activity that could lead to pregnancy, the participant must
             agree to use two reliable methods of contraception simultaneously while receiving
             study treatment and for 6 months after stopping study drug. Subjects must either be
             abstinent or a combination of TWO of the following methods MUST be used appropriately:

               -  Condoms (male or female) with or without a spermicidal agent;

               -  Diaphragm or cervical cap with spermicide;

               -  Intrauterine device (IUD);

               -  Hormonal-based contraception. Participants who are not of reproductive potential
                  (women who have been postmenopausal for at least 24 consecutive months or have
                  undergone hysterectomy, salpingotomy, bilateral oophorectomy, and/or tubal
                  ligation or men who have documented azoospermia) are eligible without requiring
                  the use of contraceptives. Acceptable documentation of sterilization, menopause
                  or male partner's azoospermia must be provided; serum follicle stimulating
                  hormone (FSH) measurement can be used to document menopausal range.

        Exclusion Criteria:

          1. Hepatic or kidney disorders or any other disease or disorder which may in the opinion
             of the Investigator interfere with the results of the study or threaten the health of
             volunteers.

          2. Clinically significant ECG abnormality according to ECG exam at Screening, subject's
             medical history or family history judged by the Investigator that the presence of, or
             an increased risk of cardiac abnormality.

          3. Positive result for HIV, HCV or HBV at Screening.

          4. Positive result for illicit drugs screen (opiates, amphetamines, cannabinoids or
             cocaine) or alcohol screen at Screening.

          5. Active alcohol or and/or drug abuse that, in the opinion of the site investigator,
             would interfere with adherence to study requirements.

          6. Received the excluded medications (as shown in Appendix 3) within 14 days or 28 days
             prior to the first dose of study drug, or within the 5 half-lives of individual
             medication, whichever is longer.

          7. Participated in a clinical study and received any investigational drug or vaccine or
             medical device within 90 days prior to the first dose of study drug.

          8. Pregnancy or breast feeding, male partners of pregnant females. Inability to
             understand the Protocol or follow its instructions.
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 40 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