Lybrido Food effect study

Voedsel effect onderzoek naar Lybrido

1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study

2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures

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

4. Healthy based on medical history, physical examination, electrocardiogram, laboratory values and vital signs

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

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

Cardiovascular conditions

1. History of myocardial infarction, stroke, transient ischemic attack, or life-threatening arrhythmia within the prior 6 months

2. Uncontrolled atrial fibrillation/flutter at screening or other significant abnormality as observed on electrocardiogram (ECG)

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

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



Gynecological and obstetric conditions

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

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

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

8. Lactating or delivery in the previous 6 months

9. 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)



Other medical conditions

10. Liver and/or renal insufficiency

11. Current clinically relevant endocrine disease

12. Positive serology for HIV, Hepatitis B (surface antigen), and/or Hepatitis C Psychological and physiological factors

13. Substance abuse disorder Concomitant medication

14. Use of nitrates or nitric oxide donor compounds

15. Subjects who are taking potent CYP3A4 inhibitors or inducers

16. Use of serotonergic drugs (e.g. Trazodon, fluvoxamide)

17. Use of testosterone therapy within 6 months before study entry

18. Use of any study medication that interferes with study medication (e.g. monoamine oxidase (MAO) inhibitors, calcium channel blockers)



General

19. Illiteracy, unwillingness or inability to follow study procedures

20. Participation in any other clinical drug study in the previous 3 months

21. Smoking