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Completed

NCT Number: NCT02983890

Dicloxacillin: Clinical Relevance of Drug-drug Interactions by Induction of Drug Metabolism.

This trial is conducted as a cocktail-study namely an open-label, randomized, two-sequence, two-period crossover, cocktail study where a combination of cocktail-drugs is used to illustrate whether or not, or to what degree dicloxacillin affects the level of activity of the 5 most important CYP enzymes and therefore plays a potentially decisive role in serious drug-drug interactions.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Klinisk Biokemisk Farmakologi syddansk universitet

Odense, Funen, 5000, Denmark

About this study

Given knowledge explains dicloxacillin and the drug warfarin to be a potential dangerous drug drug interaction because the effects of warfarin is downregulated to a degree as to where it might cause patients to have thrombotic events.

A potential explanation to this is namely dicloxacillin increases the activity of certain drug metabolising enzymes metabolising warfaring which in turn decreases the concentration of the drug in the blood and the therapeutic effect.

Cocktail study is the golden standard to investigate as to whether there is changes is P450 enzymes as a result of drug-drug interactions.

The cocktail consists of Midazolam, omeprazole, tolbutamide, caffein and dextromethorphan which is well known markers for these enzymes. These markers are safe, have specific (enzyme) metabolism and has been used in several studies with no Serious Adverse reactions reported.

By measuring the Concentration of the drug and its metabolites in plasma / Urine before and after treatment with dicloxacillin we will estimate AUC (area under the curve) and test our hypothesis/primary end point of whether there is change in AUC for Tolbutamide (CYP2C9)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Are you in a general healthy condition?; questions asked; Are you healthy in general? 2; Do you have any chronic diseases? 3; Are you taking any medications regularly? 4, Are you taking any medications periodically . 5; Are you taking nutrition supplements, "nature-medicine" or over-the-counter drugs
  • BMI; range; 18,5-29,9 kg/m2
  • eGFR(estimated glomerular filtration rate), ALAT(alanine aminotransferase), bilirubin, hæmoglobin og HbA1c, should be within normal limits or without clinically significantly deviation from these.
  • Non-Smoker

Exclusion criteria

  • Hypersensitivity to applied medications. Known allergy to penicillin or type 1-reaction to cefalosporins.
  • Known allergy to sulfonamides
  • Clinically relevant intake of receipt-required medication, over-the-counter medication or nutritional supplements.
  • Chronic or daily intake of alcohol.
  • Participation in other Intervention-studies

Treatment and study plan

Dicloxacillin

Drug

Tablets containing dicloxacillin are taken 500mg 2x 3 times per day, for 10 days. Followed by test-day nr 1 at day 11.

Both arms receives both treatments, randomly assigned

Other names: antibiotics

Placebos

Drug

No drug are taken for 10 days. Non-blinded. Followed by test-day nr 1 at day 11.

Both arms receives both treatments, randomly assigned

Primary outcomes

  1. AUC(area under the curve) for tolbutamid (CYP2C9), as a result of dicloxacillin-treatment

    Time frame: Pharmacological outcome measures at t=0 predose and postdose; 0.5,1,2,3,4,6,8,10,12,24.

    AUC measurements giving an estimate of activity og the relevant enzymes.

Secondary outcomes

  1. *AUC(area under the curve) for midazolam (CYP3A4) and dextromethorphan (CYP1A2) omeprazole (CYP2C19) and caffein (CYP1A2)

    Time frame: Pharmacological outcome measures at t=0 predose and postdose; 0.5,1,2,3,4,6,8,10,12,24.

  2. T(max)

    Time frame: Pharmacological outcome measures at t=0 predose and postdose; 0.5,1,2,3,4,6,8,10,12,24.

    The amount of time that the drug is present at the maximum concentration in serum.

  3. C(max) (peak plasma concentration)

    Time frame: Pharmacological outcome measures at t=0 predose and postdose; 0.5,1,2,3,4,6,8,10,12,24.

    The peak serum concentration of a therapeutic drug.

  4. Clearance

    Time frame: Pharmacological outcome measures at t=0 predose and postdose; 0.5,1,2,3,4,6,8,10,12,24.

    The volume of plasma from which the drug is completely removed per unit time. Reflects rate of drug elimination divided by plasma concentration.

Sponsors and collaborators

Lead sponsor

Per Damkier

Other

Registry information

Official study title

Dicloxacillin: Clinical Relevance of Drug-drug Interactions by Induction of Drug Metabolizing Enzymes.

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 6, 2016
Registry last updated
Aug 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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