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Healthy VolunteersPhase 1NCT05073627

The Effect of Dicloxacillin on Oral Absorption of Drugs

A Phase 1 study testing Dicloxacillin in people with Healthy Volunteers and Drug-drug Interaction, run by University of Southern Denmark at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Worldwide there is an increase in antibiotic resistance which may have fatal long-term consequences. This is due to extensive use and sometimes misuse of antibiotics in the treatment of harmless infections. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers, Drug-drug Interaction
What is being tested?
Dicloxacillin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteDenmark
Study dates
7 Feb 2022to 22 Jun 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age 18-55 years
  • The following data must be in the normal range or only clinical insignificantly different from this: Estimated glomerular filtration rate (eGFR), alanine aminotransferase (ALAT), bilirubin, HbA1c, hemoglobin
  • BMI >18.5 and < 30 kg/m2
  • Bodyweight ≥ 50 kg
  • Non-smoker (abstained from smoking minimum 2 weeks before the first study day and during the trial)
  • Generally healthy
  • Willing to give informed consent

Who cannot join

  • Known sensitivity to any of the used drugs or any excipients listed in section 6.1 in the Summary of Product Characteristics (SmPC)
  • Participating in any other intervention trials
  • Intake of any significant prescription drugs, over-the- counter drugs, herbal drugs, or dietary supplements*. Contraindicated drugs include:
  • Anticoagulants, antiplatelet aggregation medicinal products, ticagrelor, clopidogrel, acetylsalicylic acid, chronic NSAIDs use, amiodarone, verapamil, systemic ketoconazole, clarithromycin, cyclosporin, itraconazole, tacrolimus, posaconazole, dronedarone, glecaprevir/pibrentasvir, quinidine, ritonavir, digoxin, selective serotonin reuptake inhibitors (SSRIs), selective serotonin norephinephrine reuptake inhibitors (SNRIs), pantoprazole, ranitidine, previous use of dicloxacillin or other P-gp or Cytochrome P450 (CYP450) inhibitors/inducers within 4 weeks prior to the start of treatment, probenecid, tetracycline, methotrexate
  • 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 unites alcohol/week)
  • A positive pregnancy test at inclusion screening or any of the study days
Show all 10Show fewer
  • Known penicillin allergy or reactions against cephalosporins, cephamycin, 1-oxa-ß-lactamer, or carbapenems
  • Women who are breastfeeding
  • Diagnosis of any of the following diseases (current or previous):
  • Mechanical heart valve, congenital or acquired coagulation disorders, thrombocytopenia or functional platelet defects, biopsy within 4 weeks, major trauma, bacterial endocarditis, esophagitis, gastritis, gastroesophageal reflux, active meningitis, encephalitis, intracranial abscess, undergoing surgery, liver disease, history of thrombosis or diagnosed with antiphospholipid syndrome, active cancer

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • University of Southern Denmark

    Odense, Region Syddanmark, 5000

Other trials in Denmark

About this study

Worldwide there is an increase in antibiotic resistance which may have fatal long-term consequences. This is due to extensive use and sometimes misuse of antibiotics in the treatment of harmless infections.

The primary aim of this study is to investigate if treatment with dicloxacillin can lead to drug-drug interactions through induction of the efflux transporter P-glycoprotein (P-gp). In this study it will also be investigated whether dicloxacillin induces its own metabolism.

Read more

The hypothesis is based on a previous in vivo study showing that rifampicin induces the intestinal P-gp transporter, through activation of the pregnane X receptor (PXR). Dicloxacillin also activates the PXR receptor in vitro, which could result in an induction of P-gp in vivo.

Trial subjects will ingest dicloxacillin for 30 days and at day 10 and 28 ingest dabigatran etexilate to determine if the P-gp transporter has been induced. Plasma and urine will be drawn over 32 hours to determine the concentration of dabigatran.

Change in dicloxacillin concentration will also be measured at day 9 and 27 to establish if dicloxacillin induces its own metabolism.

Being tested
Dicloxacillin
Keywords
P-gp transporter, Induction of P-gp transporter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DicloxacillinDrug

    Also called Dabigatran etexilate

    Healthy volunteers will take 2x500 mg dicloxacillin 3 times a day for 30 days. The investigators will measure the baseline concentration of dabigatran and dicloxacillin before start of 30 days of dicloxacillin treatment. On day 9 and 27 the investigators will measure the concentration of dicloxacillin. On day 10 and 28 the investigators will measure the concentration of dabigatran.

Study groups in NCT05073627
Study groupRoleWhat they receive
BaselineNo interventionThe investigators measure the baseline of dicloxacillin and the probe drug dabigatran etexilate.
Dicloxacillin treatmentExperimentalThe investigators measure the concentration of dicloxacillin after 9 and 27 days and the concentration of dabigatran after 10 and 28 days of continuously taking dicloxacillin.
Receives: Drug: Dicloxacillin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Area under the curve (AUC) of dabigatran

    Change in the activity of the drug transporter P-gp

    Measured: Baseline and day 28

Secondary outcomes (22)

  1. Change in AUC of dabigatran

    Change in the activity of the drug transporter P-gp

    Measured: Day 10 and 28

  2. Change in AUC of relevant metabolites of dabigatran etexilate

    Change in the activity of the drug transporter P-gp

    Measured: Day 10 and 28

  3. Change in Peak Plasma concentration (Cmax) of dabigatran

    Change in the activity of the drug transporter P-gp

    Measured: Day 10 and 28

  4. Change in Cmax of relevant metabolites of dabigatran etexilate

    Change in the activity of the drug transporter P-gp

    Measured: Day 10 and 28

  5. Change in Time to reach Cmax (Tmax) of dabigatran

    Change in the activity of the drug transporter P-gp

    Measured: Day 10 and 28

  6. Change in Tmax of relevant metabolites of dabigatran etexilate

    Change in the activity of the drug transporter P-gp

    Measured: Day 10 and 28

  7. Change in renal clearance (CLr) of dabigatran

    Change in the activity of the drug transporter P-gp

    Measured: Day 10 and 28

  8. Change in CLr of relevant metabolites of dabigatran etexilate

    Change in the activity of the drug transporter P-gp

    Measured: Day 10 and 28

  9. Change in Elimination half-life (T1/2) of dabigatran

    Change in the activity of the drug transporter P-gp

    Measured: Day 10 and 28

  10. Change in T1/2 of relevant metabolites of dabigatran etexilate

    Change in the activity of the drug transporter P-gp

    Measured: Day 10 and 28

  11. Change in AUC of dicloxacillin

    Change in the activity of the enzyme responsible for metabolism of dicloxacillin

    Measured: Day 9 and 27

  12. Change in AUC of the metabolite of dicloxacillin

    Change in the activity of the enzyme responsible for metabolism of dicloxacillin

    Measured: Day 9 and 27

  13. Change in Cmax of dicloxacillin

    Change in the activity of the enzyme responsible for metabolism of dicloxacillin

    Measured: Day 9 and 27

  14. Change in Cmax of the metabolite of dicloxacillin

    Change in the activity of the enzyme responsible for metabolism of dicloxacillin

    Measured: Day 9 and 27

  15. Change in Tmax of dicloxacillin

    Change in the activity of the enzyme responsible for metabolism of dicloxacillin

    Measured: Day 9 and 27

  16. Change in Tmax of the metabolite of dicloxacillin

    Change in the activity of the enzyme responsible for metabolism of dicloxacillin

    Measured: Day 9 and 27

  17. Change in CLr of dicloxacillin

    Change in the activity of the enzyme responsible for metabolism of dicloxacillin

    Measured: Day 9 and 27

  18. Change in CLr of the metabolite of dicloxacillin

    Change in the activity of the enzyme responsible for metabolism of dicloxacillin

    Measured: Day 9 and 27

  19. Change in T1/2 of dicloxacillin

    Change in the activity of the enzyme responsible for metabolism of dicloxacillin

    Measured: Day 9 and 27

  20. Change in T1/2 of the metabolite of dicloxacillin

    Change in the activity of the enzyme responsible for metabolism of dicloxacillin

    Measured: Day 9 and 27

  21. Change in biomarkers of drug metabolism enzymes and transporters (DMET)

    Change in biomarkers for enzymes and transporters after dicloxacillin treatment

    Measured: 10 and 28

  22. Change in exosome-derived biomarkers

    Change in exosome-derived biomarkers after dicloxacillin treatment to determine activity of CYP enzymes

    Measured: 10 and 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2021
  2. Study start7 Feb 2022
  3. Primary completion22 Jun 2022
  4. Study completion22 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05073627
Sponsor's protocol ID
AKF-400
Other IDs
2021-003814-37
Status last verified
Jul 2022
First submitted
28 Sep 2021
Last updated
21 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data cannot be shared due to general data protection regulation (GDPR)

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dicloxacillin in people with Healthy Volunteers and Drug-drug Interaction, run by University of Southern Denmark at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Area under the curve (AUC) of dabigatran (time frame: Baseline and day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05073627.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.

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