E4/DRSP Single and Multiple Dose PK and Early QT Study

• Status: Completed
• Trial end date: 2016-11-21
• Target enrollment: 0
• Participant gender: Female

Summary

This study is conducted to evaluate the effect of single and multiple therapeutic and supratherapeutic oral doses of E4/DRSP combinations on PK parameters, safety, tolerability and on cardiac repolarization, as detected by QT interval corrected with Fridericia's formula (QTcF).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Estetra
• Treatments: Drospirenone

Criteria

Inclusion Criteria:

1. Gender : Healthy female subject

2. Age : 18-50 years, inclusive

3. Body mass index (BMI) : 18.0-35.0 kg/m2

4. At screening, female subjects must be non-pregnant and non-lactating, or of non-childbearing potential

5. Willing to use a double-barrier method of contraception from screening until 90 days after the follow up visit.

6. Willingness to abstain from alcohol and grapefruit (juice) from 48 hours prior to admission into the clinical research center up to follow-up.

7. Normal resting supine blood pressure and pulse showing no clinically relevant deviations as judged by the PI at screening.

8. Computerized (12-lead) ECG recording without signs of clinically relevant pathology at screening

9. Willing and able to sign the ICF.

10. Willing and able to comply with the study procedures

Exclusion Criteria:

1. Postmenopausal status

2. History or presence of clinically relevant disease of any major system organ class (e.g., cardiovascular, pulmonary, renal, hepatic, gastrointestinal, reproductive, endocrinological, neurological, psychiatric or orthopedic disease) as judged by the PI

3. Condition of hyperkalemia resulting from renal insufficiency, hepatic dysfunction, adrenal insufficiency or medication intake

4. Previous participation in the current study

5. Use of:

• combined contraceptives (i.e., COC, Nuvaring®) within 28 days prior to the first dose administration until study completion

• progestogen-only contraceptive methods (e.g., minipill, implant, or hormonal intrauterine system) within 28 days prior to the first dose administration until study completion

• depot progestogen preparations or an injectable hormonal method of contraception (e.g., Depo-Provera®) within 6 months prior to the first dose until study completion

6. Use of:

• any prescription drugs or herbal supplements acting on CYP3A4 functions (e.g., St. John's Wort) within 28 days prior to the first study dose administration until study completion

• any over-the-counter medication or dietary supplements (vitamins included) within 14 days prior to the first study dose administration until study completion.

7. Use of any tobacco products within the last 3 months prior to the first admission

8. History of alcohol abuse or drug addiction (including soft drugs like cannabis products)

9. Positive drug screening

10. Positive screen for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) 1 and 2 antibodies

11. Participation in an investigational drug study within 60 days prior to the first drug administration in the current study

12. History of relevant drug and/or food allergies

13. Donation or loss of more than 100 mL of blood within 60 days prior to the first drug administration. Donation or loss of more than 1.0 L of blood in the 10 months prior to the first drug administration in the current study

14. Significant and/or acute illness within 5 days prior to the first drug administration that may impact safety assessments, as judged by the PI

15. History and/or family history of congenital long QT syndrome, unexplained syncope or other additional risks for Torsade de Pointes, or sudden death

16. History or presence of hormone-related malignancy treated or not, whatever the time of onset. History of malignancy of any other organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years prior to screening

17. History of migraine with aura

18. Any surgical or medical condition that could significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study

19. Contraindications for the use of contraceptive steroids

20. Sponsor employees or clinical site personnel directly affiliated with this study