Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2019-02-13
2019-04-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
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Rivaroxaban
Single oral dose of 20 mg rivaroxaban
Rivaroxaban
20 mg rivaroxaban.
Rivaroxaban after CYP- and P-gp induction
Single oral dose of 20 mg rivaroxaban after pretreatment with St. John's wort extract (Jarsin®) twice daily 450 mg po for 2 weeks.
St Johns Wort Extract
20 mg rivaroxaban after supplementation with St. John's wort extract (Jarsin®) twice daily 450 mg po for 2 weeks.
Rivaroxaban
20 mg rivaroxaban.
Interventions
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St Johns Wort Extract
20 mg rivaroxaban after supplementation with St. John's wort extract (Jarsin®) twice daily 450 mg po for 2 weeks.
Rivaroxaban
20 mg rivaroxaban.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
45 Years
ALL
Yes
Sponsors
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Bayer
INDUSTRY
Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Inselpital
Role: STUDY_DIRECTOR
Sponsor: Inselspital, Bern University Hospital
Locations
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Inselspital
Bern, , Switzerland
Countries
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References
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Scholz I, Liakoni E, Hammann F, Grafinger KE, Duthaler U, Nagler M, Krahenbuhl S, Haschke M. Effects of Hypericum perforatum (St John's wort) on the pharmacokinetics and pharmacodynamics of rivaroxaban in humans. Br J Clin Pharmacol. 2021 Mar;87(3):1466-1474. doi: 10.1111/bcp.14553. Epub 2020 Oct 25.
Other Identifiers
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Studien-Nr. 3459
Identifier Type: -
Identifier Source: org_study_id