Lybridos Food effect study
Voedsel effect onderzoek naar Lybridos

1. Provision of informed consent

2. Females between 18 and 55 years of age (both inclusive)

3. Healthy based on medical history, physical examination (including vital signs), electrocardiogram, laboratory values

4. Body mass index (BMI) ≥18 kg/m2 and ≤ 30 kg/m2

5. Venous access sufficient to allow blood sampling as per protocol

Cardiovascular conditions

1. Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg.

2. Systolic blood pressure < 90 mmHg and/or diastolic blood pressure< 50 mmHg



Gynaecological and obstetric conditions

3. Use of oral contraceptives containing anti-androgens (e.g. crypteron acetate) or anti (androgenic) progestogens (drosperidone, dienogest, chlormadinone acetate and norgestrel)

4. Use of any hormone replacement therapy (HRT) containing more than 50 µg/day of estrogen

5. Pregnancy (note: an urine pregnancy test will be performed in all women prior to the administration of study medication)

6. Lactating or delivery in the previous 6 months

7. Perimenopausal status (cycle shortening/irregular menstrual bleeding in the last 12 consecutive months and/or occurrence of vasomotor symptoms (e.g. hot flashes, night contraceptive sweating) in combination with elevated FSH levels (>40 IU/L) for women age 40 onwards; in women with a history of hysterectomy, perimenopausality can be assessed by FSH levels (>40 IU/L) and/or vasomotor symptoms)



General

8. Use of any drugs from two weeks prior to admission to the research unit until the follow-up visit, except for allowed oral contraceptives and pain relief (e.g. paracetamol up to 1.5 g per day)

9. Known or suspected hypersensitivity to any of the components of the formulation

10. Liver function tests (i.e., alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin) significantly above the upper limit of normal (ULN) at repeated measures

11. Any clinically significant history or any other disease or disorder- gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric, or metabolic as judged by the medical investigator

12. Smoking

13. Unwilling or unable to refrain from consuming grapefruit juice, star fruit and St. Johns Wort 24 hours before and after intake of medication

14. Current regular use of any illicit drugs or history of excessive drinking within 3 months prior to admission to the research unit and/or unwilling or unable to refrain from products containing alcohol from 24 hours before admission and during the stay in the research unit

15. Donation of blood within 3 months prior to admission to the research unit

16. Positive serology test for hepatitis B serum antigen (HBsAg), anti-hepatitis A virus (HAV) (IgM), anti-hepatitis C virus (HCV) or anti human immunodeficiency virus (HIV) 1+2

17. Subjects who, in the opinion of the investigator, are not likely to complete the trial for any reason

18. Participation in any clinical study within 1 month prior to the expected date of enrolment into the study.

19. Employees of the sponsor or CRO involved in the study