| 1. Healthy males and females, 18 to 55 years (both inclusive) at the time of signing of informed consent.
2. Body mass index (BMI) ≥ 18.5 and ≤ 30 kg/m2.
3. Body weight not less than 50 kg for males and 51 kg for females.
4. Medical history, vital signs, physical examination, standard 12-lead ECG (including QT interval corrected with the Fridericia formula [QTcF] of ≤ 450 msec), and laboratory investigations within laboratory reference ranges, or if outside reference ranges, the out of range results are considered as not clinically significant. Acceptable reference ranges will be agreed with the Sponsor before study start.
5. Normal blood pressure (BP): Systolic BP between 90 and 140 mmHg (inclusive), diastolic BP 45 to 90 mmHg (inclusive), measured after 10 min rest in supine position.
6. Non-smokers or mild smokers (≤ 5 cigarettes or pipes per day).
7. Females, if:
• Not of childbearing potential, e.g., has been surgically sterilized (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) or is postmenopausal (had no menses for 12 months without an alternative medical cause and a serum follicle stimulating hormone [FSH] concentration ≥40 IU/L),
Note: In postmenopausal women, the value of the serum pregnancy test may be slightly increased. This test will be repeated to confirm the results. If there is no increase indicative of pregnancy, the female will be included in the study.
• Of childbearing potential, the following conditions are to be met:
Negative pregnancy test
If this test is positive, the subject will be excluded from the study. In the rare circumstance that a pregnancy is discovered after the subject received IP, every attempt must be made to follow her to term. The subject will also be informed of the teratogenic risk with Ancotil® and will be advised of the importance of careful prenatal and postnatal monitoring.
Not breastfeeding and must agree not to breastfeed while participating in the study and for up to 1 month after the la |
1. Evidence of psychiatric disorder, antagonistic functioning, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
2. Current alcohol use > 14 units of alcohol per week for males and > 7 units of alcohol per week for females (1 unit is equal to approximately 330 mL of beer, one small glass [200 mL] of wine, or one measure [25 mL] of spirits).
3. Regular exposure to substances of abuse (other than alcohol) within the past year.
4. Use of any medication, prescribed or over-the-counter (including herbal remedies and St. John's wort [Hypericum perforatum]), within 2 weeks or 5 elimination half-lives of medication or remedies before the first administration of IP, whichever is longer.
5. SARS-CoV-2 vaccination received within 2 weeks before the first administration of IP, or a dose of vaccination planned during the study period.
6. Participation in another study with an experimental drug, where the last administration of the previous IP was within 8 weeks (or within 5 elimination half-lives for chemical entities or 2 elimination half-lives for antibodies or insulin, whichever is the longer) before administration of IP in this study.
7. Participation in the DNDi-5FC-01-CM (fasted) study.
8. Treatment within the previous 3 months before the first administration of IP with any drug with a well-defined potential for adversely affecting a major organ or system.
9. Treatment with potent inhibitors of dihydropyrimidine dehydrogenase (DPD) in the previous 4 weeks: Antiviral antiherpetic nucleoside agents (e.g., brivudine, sorivudine and their analogues) or Uracil.
10. Dihydropyrimidine dehydrogenase (DPD) deficiency defined as a plasma uracil level of > 16 ng/mL.
11. Treatment with a not recommended and contraindicated medication as per Ancotil® SmPC (see Appendix 15.2) within 2 weeks before the first administration of IP.
12. A major illness during the |
Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) |
18 Year(s) |
55 Year(s) |
Both |