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 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? Entailment