Healthy VolunteersPhase 1NCT04840641
Flucloxacillin as an Inducer of CYP-enzymes
A Phase 1 study testing Flucloxacillin in people with Healthy Volunteers and Drug Drug Interaction, run by University of Southern Denmark at 1 site in Denmark.
Trial 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 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?
- Flucloxacillin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Mar 2021to 28 Dec 2021
- 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 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
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).
- 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)
Show all 9Show fewer
- Women who are breastfeeding
- Positive pregnancy test at inclusion screening or at any of the study days
- Participation in any other interventional trials
Trial locations and contacts
1 site in 1 country.
About this study
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 harmless infections.
The aim of this study is to investigate if treatment with flucloxacillin increases drug metabolism in healthy volunteers through induction of cytochrome P450 (CYP) enzymes, CYP1A4, CYP2B6, CYP2C9, CYP2C19, CYP2D6, and CYP3A4.
Read more
The hypothesis is based on an in vitro study showing that flucloxacillin activates a receptor (PXR) responsible for transcription of CYP enzymes.
Trial subjects will ingest flucloxacillin for 31 days and at day 10 and 28 ingest a cocktail of 6 drugs to determine if the CYP enzymes have been induced. Plasma and urine will be drawn over 72 hours to determine the concentration of the 6 drugs and their metabolites.
Change in flucloxacillin concentration will also be measured at day 9 and 27 to establish if flucloxacillin induces its own metabolism.
- Conditions
- Healthy Volunteers, Drug Drug Interaction
- Being tested
- Flucloxacillin
- Keywords
- CYP enzymes, Induction of CYP enzymes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlucloxacillinDrug
Also called Caffeine, Efavirenz, Losartan, Omeprazole
Healthy volunteers will take 2x500 mg flucloxacillin 3 times a day for 31 days. The investigators will measure the baseline concentration of the 6-cocktaildrugs and flucloxacillin before start of 31 days of flucloxacillin treatment. On day 9 and 27 the investigators will measure the concentration of flucloxacillin. On day 10 and 28 the investigators will measure the concentration of the 6 cocktaildrugs
| Study group | Role | What they receive |
|---|---|---|
| Baseline | No intervention | The investigators measure the baseline of flucloxacillin and cocktaildrugs. |
| Flucloxacillin treatment | Experimental | The investigators measure the concentration of flucloxacillin after 9 and 27 days and the concentration of cocktaildrugs after 10 and 28 days. Receives: Drug: Flucloxacillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Area under curve (AUC) of midazolam
Change in the activity of the drug metabolizing enzyme CYP3A4
Measured: Baseline and day 28
Secondary outcomes (70)
Change in AUC of midazolam
Change in the activity of the drug metabolizing enzyme CYP3A4
Measured: Day 10 and 28
Change in AUC of the metabolite of midazolam
Change in the activity of the drug metabolizing enzyme CYP3A4
Measured: Day 10 and 28
Change in Peak Plasma concentration (Cmax) of midazolam
Change in the activity of the drug metabolizing enzyme CYP3A4
Measured: Day 10 and 28
Change in Cmax of the metabolite of midazolam
Change in the activity of the drug metabolizing enzyme CYP3A4
Measured: Day 10 and 28
Change in Time to reach Cmax (Tmax) of midazolam
Change in the activity of the drug metabolizing enzyme CYP3A4
Measured: Day 10 and 28
Change in Tmax of the metabolite of midazolam
Change in the activity of the drug metabolizing enzyme CYP3A4
Measured: Day 10 and 28
Change in Renal Clearence (CLr) of midazolam
Change in the activity of the drug metabolizing enzyme CYP3A4
Measured: Day 10 and 28
Change in CLr of the metabolite of midazolam
Change in the activity of the drug metabolizing enzyme CYP3A4
Measured: Day 10 and 28
Change in Elimination half-life (T1/2) of midazolam
Change in the activity of the drug metabolizing enzyme CYP3A4
Measured: Day 10 and 28
Change in T1/2 of the metabolite of midazolam
Change in the activity of the drug metabolizing enzyme CYP3A4
Measured: Day 10 and 28
Change in AUC of metoprolol
Change in the activity of the drug metabolizing enzyme CYP2D6
Measured: Day 10 and 28
Change in AUC of the metabolite of metoprolol
Change in the activity of the drug metabolizing enzyme CYP2D6
Measured: Day 10 and 28
Change in Cmax of metoprolol
Change in the activity of the drug metabolizing enzyme CYP2D6
Measured: Day 10 and 28
Change in Cmax of the metabolite of metoprolol
Change in the activity of the drug metabolizing enzyme CYP2D6
Measured: Day 10 and 28
Change in Tmax of metoprolol
Change in the activity of the drug metabolizing enzyme CYP2D6
Measured: Day 10 and 28
Change in Tmax of the metabolite of metoprolol
Change in the activity of the drug metabolizing enzyme CYP2D6
Measured: Day 10 and 28
Change in CLr of metoprolol
Change in the activity of the drug metabolizing enzyme CYP2D6
Measured: Day 10 and 28
Change in CLr of the metabolite of metoprolol
Change in the activity of the drug metabolizing enzyme CYP2D6
Measured: Day 10 and 28
Change in T1/2 of metoprolol
Change in the activity of the drug metabolizing enzyme CYP2D6
Measured: Day 10 and 28
Change in T1/2 of the metabolite of metoprolol
Change in the activity of the drug metabolizing enzyme CYP2D6
Measured: Day 10 and 28
Change in AUC of omeprazole
Change in the activity of the drug metabolizing enzyme CYP2C19
Measured: Day 10 and 28
Change in AUC of the metabolite of omeprazole
Change in the activity of the drug metabolizing enzyme CYP2C19
Measured: Day 10 and 28
Change in Cmax of omeprazole
Change in the activity of the drug metabolizing enzyme CYP2C19
Measured: Day 10 and 28
Change in Cmax of the metabolite of omeprazole
Change in the activity of the drug metabolizing enzyme CYP2C19
Measured: Day 10 and 28
Change in Tmax of omeprazole
Change in the activity of the drug metabolizing enzyme CYP2C19
Measured: Day 10 and 28
Change in Tmax of the metabolite of omeprazole
Change in the activity of the drug metabolizing enzyme CYP2C19
Measured: Day 10 and 28
Change in CLr of omeprazole
Change in the activity of the drug metabolizing enzyme CYP2C19
Measured: Day 10 and 28
Change in CLr of the metabolite of omeprazole
Change in the activity of the drug metabolizing enzyme CYP2C19
Measured: Day 10 and 28
Change in T1/2 of omeprazole
Change in the activity of the drug metabolizing enzyme CYP2C19
Measured: Day 10 and 28
Change in T1/2 of the metabolite of omeprazole
Change in the activity of the drug metabolizing enzyme CYP2C19
Measured: Day 10 and 28
Change in AUC of losartan
Change in the activity of the drug metabolizing enzyme CYP2C9
Measured: Day 10 and 28
Change in AUC of the metabolite of losartan
Change in the activity of the drug metabolizing enzyme CYP2C9
Measured: Day 10 and 28
Change in Cmax of losartan
Change in the activity of the drug metabolizing enzyme CYP2C9
Measured: Day 10 and 28
Change in Cmax of the metabolite of losartan
Change in the activity of the drug metabolizing enzyme CYP2C9
Measured: Day 10 and 28
Change in Tmax of losartan
Change in the activity of the drug metabolizing enzyme CYP2C9
Measured: Day 10 and 28
Change in Tmax of the metabolite of losartan
Change in the activity of the drug metabolizing enzyme CYP2C9
Measured: Day 10 and 28
Change in CLr of losartan
Change in the activity of the drug metabolizing enzyme CYP2C9
Measured: Day 10 and 28
Change in CLr of the metabolite of losartan
Change in the activity of the drug metabolizing enzyme CYP2C9
Measured: Day 10 and 28
Change in T1/2 of losartan
Change in the activity of the drug metabolizing enzyme CYP2C9
Measured: Day 10 and 28
Change in T1/2 of the metabolite of losartan
Change in the activity of the drug metabolizing enzyme CYP2C9
Measured: Day 10 and 28
Change in AUC of efavirenz
Change in the activity of the drug metabolizing enzyme CYP2B6
Measured: Day 10 and 28
Change in AUC of the metabolite of efavirenz
Change in the activity of the drug metabolizing enzyme CYP2B6
Measured: Day 10 and 28
Change in Cmax of efavirenz
Change in the activity of the drug metabolizing enzyme CYP2B6
Measured: Day 10 and 28
Change in Cmax of the metabolite of efavirenz
Change in the activity of the drug metabolizing enzyme CYP2B6
Measured: Day 10 and 28
Change in Tmax of efavirenz
Change in the activity of the drug metabolizing enzyme CYP2B6
Measured: Day 10 and 28
Change in Tmax of the metabolite of efavirenz
Change in the activity of the drug metabolizing enzyme CYP2B6
Measured: Day 10 and 28
Change in CLr of efavirenz
Change in the activity of the drug metabolizing enzyme CYP2B6
Measured: Day 10 and 28
Change in CLr of the metabolite of efavirenz
Change in the activity of the drug metabolizing enzyme CYP2B6
Measured: Day 10 and 28
Change in T1/2 of efavirenz
Change in the activity of the drug metabolizing enzyme CYP2B6
Measured: Day 10 and 28
Change in T1/2 of the metabolite of efavirenz
Change in the activity of the drug metabolizing enzyme CYP2B6
Measured: Day 10 and 28
Change in AUC of caffeine
Change in the activity of the drug metabolizing enzyme CYP1A2
Measured: Day 10 and 28
Change in AUC of the metabolite of caffeine
Change in the activity of the drug metabolizing enzyme CYP1A2
Measured: Day 10 and 28
Change in Cmax of caffeine
Change in the activity of the drug metabolizing enzyme CYP1A2
Measured: Day 10 and 28
Change in Cmax of the metabolite of caffeine
Change in the activity of the drug metabolizing enzyme CYP1A2
Measured: Day 10 and 28
Change in Tmax of caffeine
Change in the activity of the drug metabolizing enzyme CYP1A2
Measured: Day 10 and 28
Change in Tmax of the metabolite of caffeine
Change in the activity of the drug metabolizing enzyme CYP1A2
Measured: Day 10 and 28
Change in CLr of caffeine
Change in the activity of the drug metabolizing enzyme CYP1A2
Measured: Day 10 and 28
Change in CLr of the metabolite of caffeine
Change in the activity of the drug metabolizing enzyme CYP1A2
Measured: Day 10 and 28
Change in T1/2 of caffeine
Change in the activity of the drug metabolizing enzyme CYP1A2
Measured: Day 10 and 28
Change in T1/2 of the metabolite of caffeine
Change in the activity of the drug metabolizing enzyme CYP1A2
Measured: Day 10 and 28
Change in AUC of flucloxacillin
Change in the activity of the enzyme responsible for metabolism of flucloxacillin
Measured: Day 9 and 27
Change in AUC of the metabolite of flucloxacillin
Change in the activity of the enzyme responsible for metabolism of flucloxacillin
Measured: Day 9 and 27
Change in Cmax of flucloxacillin
Change in the activity of the enzyme responsible for metabolism of flucloxacillin
Measured: Day 9 and 27
Change in Cmax of the metabolite of flucloxacillin
Change in the activity of the enzyme responsible for metabolism of flucloxacillin
Measured: Day 9 and 27
Change in Tmax of flucloxacillin
Change in the activity of the enzyme responsible for metabolism of flucloxacillin
Measured: Day 9 and 27
Change in Tmax of the metabolite of flucloxacillin
Change in the activity of the enzyme responsible for metabolism of flucloxacillin
Measured: Day 9 and 27
Change in CLr of flucloxacillin
Change in the activity of the enzyme responsible for metabolism of flucloxacillin
Measured: Day 9 and 27
Change in CLr of the metabolite of flucloxacillin
Change in the activity of the enzyme responsible for metabolism of flucloxacillin
Measured: Day 9 and 27
Change in T1/2 of flucloxacillin
Change in the activity of the enzyme responsible for metabolism of flucloxacillin
Measured: Day 9 and 27
Change in T1/2 of the metabolite of flucloxacillin
Change in the activity of the enzyme responsible for metabolism of flucloxacillin
Measured: Day 9 and 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start25 Mar 2021
- Primary completion17 Dec 2021
- Study completion28 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- SignaTope GmbH, Germany
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840641
- Sponsor's protocol ID
- AKF-396
- Other IDs
- 2020-004044-28
- Status last verified
- Jan 2022
- First submitted
- 23 Mar 2021
- Last updated
- 11 Jan 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).
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flucloxacillin as an Inducer of CYP-enzymes
- ClinicalTrials.gov ID
- NCT04840641
- Acronym / sponsor ID
- AKF-396
- Conditions
- Healthy Volunteers, Drug Drug Interaction
- Keywords
- CYP enzymes, Induction of CYP enzymes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- SignaTope GmbH, Germany
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 harmless infections.
The aim of this study is to investigate if treatment with flucloxacillin increases drug metabolism in healthy volunteers through induction of cytochrome P450 (CYP) enzymes, CYP1A4, CYP2B6, CYP2C9, CYP2C19, CYP2D6, and CYP3A4.
The hypothesis is based on an in vitro study showing that flucloxacillin activates a receptor (PXR) responsible for transcription of CYP enzymes.
Trial subjects will ingest flucloxacillin for 31 days and at day 10 and 28 ingest a cocktail of 6 drugs to determine if the CYP enzymes have been induced. Plasma and urine will be drawn over 72 hours to determine the concentration of the 6 drugs and their metabolites.
Change in flucloxacillin concentration will also be measured at day 9 and 27 to establish if flucloxacillin induces its own metabolism.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline | No intervention | –The investigators measure the baseline of flucloxacillin and cocktaildrugs. |
| Flucloxacillin treatment | Experimental | Drug: FlucloxacillinThe investigators measure the concentration of flucloxacillin after 9 and 27 days and the concentration of cocktaildrugs after 10 and 28 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlucloxacillinAlso: Caffeine, Efavirenz, Losartan, OmeprazoleHealthy volunteers will take 2x500 mg flucloxacillin 3 times a day for 31 days. The investigators will measure the baseline concentration of the 6-cocktaildrugs and flucloxacillin before start of 31 days of flucloxacillin treatment. On day 9 and 27 the investigators will measure the concentration of flucloxacillin. On day 10 and 28 the investigators will measure the concentration of the 6 cocktaildrugs | Drug | Flucloxacillin treatment |
Primary outcome
Change in Area under curve (AUC) of midazolam
Time frame: Baseline and day 28
Change in the activity of the drug metabolizing enzyme CYP3A4
70 secondary outcomes
Change in AUC of midazolam
Time frame: Day 10 and 28
Change in AUC of the metabolite of midazolam
Time frame: Day 10 and 28
Change in Peak Plasma concentration (Cmax) of midazolam
Time frame: Day 10 and 28
Change in Cmax of the metabolite of midazolam
Time frame: Day 10 and 28
Change in Time to reach Cmax (Tmax) of midazolam
Time frame: Day 10 and 28
Change in Tmax of the metabolite of midazolam
Time frame: Day 10 and 28
Change in Renal Clearence (CLr) of midazolam
Time frame: Day 10 and 28
Change in CLr of the metabolite of midazolam
Time frame: Day 10 and 28
Change in Elimination half-life (T1/2) of midazolam
Time frame: Day 10 and 28
Change in T1/2 of the metabolite of midazolam
Time frame: Day 10 and 28
Change in AUC of metoprolol
Time frame: Day 10 and 28
Change in AUC of the metabolite of metoprolol
Time frame: Day 10 and 28
Change in Cmax of metoprolol
Time frame: Day 10 and 28
Change in Cmax of the metabolite of metoprolol
Time frame: Day 10 and 28
Change in Tmax of metoprolol
Time frame: Day 10 and 28
Change in Tmax of the metabolite of metoprolol
Time frame: Day 10 and 28
Change in CLr of metoprolol
Time frame: Day 10 and 28
Change in CLr of the metabolite of metoprolol
Time frame: Day 10 and 28
Change in T1/2 of metoprolol
Time frame: Day 10 and 28
Change in T1/2 of the metabolite of metoprolol
Time frame: Day 10 and 28
Change in AUC of omeprazole
Time frame: Day 10 and 28
Change in AUC of the metabolite of omeprazole
Time frame: Day 10 and 28
Change in Cmax of omeprazole
Time frame: Day 10 and 28
Change in Cmax of the metabolite of omeprazole
Time frame: Day 10 and 28
Change in Tmax of omeprazole
Time frame: Day 10 and 28
Change in Tmax of the metabolite of omeprazole
Time frame: Day 10 and 28
Change in CLr of omeprazole
Time frame: Day 10 and 28
Change in CLr of the metabolite of omeprazole
Time frame: Day 10 and 28
Change in T1/2 of omeprazole
Time frame: Day 10 and 28
Change in T1/2 of the metabolite of omeprazole
Time frame: Day 10 and 28
Change in AUC of losartan
Time frame: Day 10 and 28
Change in AUC of the metabolite of losartan
Time frame: Day 10 and 28
Change in Cmax of losartan
Time frame: Day 10 and 28
Change in Cmax of the metabolite of losartan
Time frame: Day 10 and 28
Change in Tmax of losartan
Time frame: Day 10 and 28
Change in Tmax of the metabolite of losartan
Time frame: Day 10 and 28
Change in CLr of losartan
Time frame: Day 10 and 28
Change in CLr of the metabolite of losartan
Time frame: Day 10 and 28
Change in T1/2 of losartan
Time frame: Day 10 and 28
Change in T1/2 of the metabolite of losartan
Time frame: Day 10 and 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: No. Individual participant data cannot be shared due to general data protection regulation (GDPR).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Flucloxacillin 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 6 inclusion and 9 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 11 Jan 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 curve (AUC) of midazolam (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?
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 11 Jan 2022.