Rivaroxaban Hypericum Trial

• Status: Completed
• Trial end date: 2019-04-09
• Target enrollment: 0
• Participant gender: All

Summary

Single-center, open-label, sequential treatment study to investigate the influence of the combined P-glycoprotein and CYP3A4 inducer hypericum perforatum on the pharmacokinetics and pharmacodynamics of rivaroxaban in healthy volunteers.

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

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborator: Bayer
• Treatments: Rivaroxaban

Criteria

Inclusion Criteria:

• Men or women, age between 18 and 45 years (inclusive) at screening

• BMI between 18 and 28 kg/m2 (inclusive) at screening

• No clinically significant findings on the physical examination at screening

• Hematology and clinical chemistry results not deviating from the normal range to a clinically relevant extent at screening

• Ability to communicate well with the investigator and to understand and comply with the requirements of the study

• Women of child-bearing age: willingness of using a double barrier contraception method during the study, i.e. a hormonal method (oral contraceptive, intrauterine device) in combination with a mechanical barrier (e.g. condom, diaphragm)

• Signed informed consent

Exclusion Criteria:

• Known allergic reaction to any excipient of the drug formulations

• Known photosensitivity

• Smoking

• History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening

• Loss of ≥ 250 ml of blood within 3 months prior to screening, including blood donation

• Treatment with an investigational drug within 30 days prior to screening

• Previous treatment with any prescribed or over-the-counter medications (including herbal medicines such as St. John's wort) within 2 weeks prior to screening

• Pregnant (positive results from urine drug screen at screening) or lactating women

• History or clinical evidence of any disease (e.g. gastrointestinal tract disease) and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drugs, or which might increase the risk for toxicity

• Legal incapacity or limited legal capacity at screening

• Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol