Status:
COMPLETED
Flucloxacillin as an Inducer of CYP-enzymes
Lead Sponsor:
University of Southern Denmark
Collaborating Sponsors:
SignaTope GmbH, Germany
Conditions:
Healthy Volunteers
Drug Drug Interaction
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Worldwide there is an increase in antibiotic resistance which may have potential fatal long-term consequences. This is due to extensive use and sometimes misuse of antibiotics in the treatment of harm...
Eligibility Criteria
Inclusion
- Age 18-55 years
- The following data have to be in the normal range or only clinical insignificantly different from this: eGFR, ALAT, bilirubin, HbA1c, haemoglobin
- BMI 18.5 - 29.9 kg m-2
- Non-smoker (abstained from smoking minimum 2 weeks before the first study day and during the trial)
- Generally healthy
- Willing to give informed consent
Exclusion
- Known sensitivity to any of the used drugs or any excipients listed in section 6.1 in the Summary of Product Characteristics (SmPC).
- Known allergy towards penicillin or cephalosporines
- Any of the following diseases (current or previous):
- Heart disease, known family history of prolonged QTc interval, sudden death or conditions that might prolonged QTc-intervals, hypotension, severe disturbance of electrolyte balance e.g. hypokalemia or hypomagnesemia, myasthenia gravis, lung- or respiratory diseases, an anatomically abnormality of the respiratory tract, sleep apnea syndrome
- \- Intake of any significant prescription drugs, over-the- counter drugs, herbal drugs or dietary supplements. Contraindicated drugs include: Benzodiazepines, beta blockers, ergot alkaloids, herbal preparations containing St. John's wort, antiarrhythmics, neuroleptics, antidepressive agents, antibiotics, antifungal agents, non-sedating antihistamines, antimalarials, methadone, elbasvir, grazoprevir, nelfinavir cisapride, pimozide, bepridil
- Alcohol abuse or if the Danish Health Authority recommendation regarding alcohol intake has been exceeded 2 weeks before the first study day (men 14 units alcohol/week, women 7 units alcohol/week)
- Women who are breastfeeding
- Positive pregnancy test at inclusion screening or at any of the study days
- Participation in any other interventional trials
Key Trial Info
Start Date :
March 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2021
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04840641
Start Date
March 25 2021
End Date
December 28 2021
Last Update
January 11 2022
Active Locations (1)
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1
University of Southern Denmark
Odense, Region Syddanmark, Denmark, 5000