Clinical trial: A Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study of TLL018, With Food Effect, in Healthy Participants (NCT04243083)

Eligibility criteria:
Inclusion Criteria:

          1. Are capable of giving informed consent and complying with study procedures;

          2. Are between the ages of 18 and 55 years, inclusive;

          3. Female subjects have a negative serum hCG or urine pregnancy test result at screening
             and Day -1, and meet one of the following criteria:

               1. Using a medically acceptable form of birth control for at least 1 month prior to
                  screening (3 months on oral contraceptives) [e.g., hormonal contraceptives (oral,
                  patch, injectable or vaginal ring), implantable device (implantable rod or
                  intrauterine device), or a double barrier (e.g., diaphragm, cervical cap, oral,
                  patch or vaginal hormonal contraceptive, condom, spermicide, or sponge)]

               2. Surgically sterile, with documentation, for at least 3 months prior to screening
                  by one of the following means:

                    -  Bilateral tubal ligation

                    -  Bilateral salpingectomy (with or without oophorectomy)

                    -  Surgical hysterectomy

                    -  Bilateral oophorectomy (with or without hysterectomy)

               3. Postmenopausal, defined as the following:

                    -  Last menstrual period greater than 12 months prior to screening

                    -  Postmenopausal status confirmed by serum follicle stimulating hormone (FSH)
                       and estradiol levels at screening;

          4. Considered healthy by the Investigator, based on subject's reported medical history,
             full physical examination, clinical laboratory tests, 12-lead ECG, and vital signs;

          5. Normal renal function as determined by Investigator following review of clinical
             laboratory test results;

          6. Non-smoker or no more than 2 tobacco-containing including nicotine replacement
             products in last 6 months;

          7. Body mass index (BMI) of 18.0 to 30.0 kg/m2 inclusive and body weight not less than 50
             kg; Subjects with BMI between 30 and 32 kg/m2 may be allowed to participate with the
             sponsor's approval;

          8. Willing and able to adhere to study restrictions and to be confined at the clinical
             research center;

          9. Male subjects with female partners of child-bearing potential must agree to use
             condoms for the duration of the study and until 12 weeks after dosing with the study
             drug and must refrain from donating sperm for this same period;

         10. Ability to swallow and retain oral medication.

        Exclusion Criteria:

          1. Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal,
             endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic,
             immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the
             Investigator;

          2. Pregnant (as determined by pregnancy test result) and breastfeeding women;

          3. Current and/or recent history (<30 days prior to screening and/or <45 days prior to
             randomization) of a clinically significant bacterial, fungal, parasitic, or
             mycobacterial infection;

          4. Current clinically significant viral infection;

          5. Evidence of latent or active tuberculosis, as well as recent exposure or live
             vaccinations

          6. History of malignancy, with the exception of cured basal cell or squamous cell
             carcinoma of the skin;

          7. History of pancreatitis or gall stones;

          8. History of unexplained syncope, symptomatic hypotension or hypoglycemia;

          9. Family history of long QTc syndrome; History or presence of an abnormal ECG, which, in
             the investigator's opinion, is clinically significant. QTcF interval >440 msec for
             males and >460 msec for females;

         10. Resting pulse <45 bpm or >100 bpm at screening, only with Day -1 as PI judgement;

         11. History of unstable ischemic heart disease or uncontrolled hypertension (blood
             pressure >140/90 mm Hg at screening, only with Day -1 as PI judgement);

         12. History of stomach or intestinal surgery, except that appendectomy and/or
             cholecystectomy will be allowed;

         13. History of chronic diarrhea, malabsorption, unexplained weight loss, food allergies or
             intolerance;

         14. Poor venous access;

         15. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface
             antigen (HBsAg), or hepatitis C antibody;

         16. Donated or lost >500 ml of blood in the previous 3 months;

         17. Taken any prescription medications within 7 days or 5 half-lives (whichever is longer)
             of the first dose of study drug;

         18. Hospital admission or major surgery within 6 months prior to screening;

         19. A history of prescription drug abuse, or illicit drug use within 9 months prior to
             screening;

         20. A history of alcohol abuse according to medical history within 9 months prior to
             screening;

         21. A positive screen for alcohol or drugs of abuse at screening or Day -1;

         22. An unwillingness or inability to comply with food and beverage restrictions during
             study participation;

         23. Use of over-the-counter (OTC) medication within 7 days, and herbal (including St
             John's Wort, herbal teas, garlic extracts) within 7 days prior to dosing (Note: Use of
             acetaminophen at <2 g/day is permitted until 24 hours prior to dosing);

         24. Current treatment or treatment within 30 days or 5 half-lives (whichever is longer)
             prior to the first dose of study medication with another investigational medication or
             current enrollment in another investigational drug protocol;

         25. Hemoglobin, WBC, or platelet count below the lower reference limit of the testing
             laboratory. Absolute neutrophil count <2000 cells/uL;

         26. Any condition or finding that in the Investigators opinion would put the subject or
             study conduct at risk if the subject were to participate in the study
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 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? Contradiction