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AzTrials

Drug-Drug InteractionsPhase 1NCT07426042

Effect of Dexamethasone on CYP Enzyme Activity in Healthy Male Subjects

A Phase 1 study testing Dexamethasone, CYP Probe Cocktail and voriconazole in people with Drug-Drug Interactions, run by Min Kyu Park.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Purpose: The purpose of this study is to understand how dexamethasone affects the activity of drug-metabolizing enzymes in the body and how this may influence interactions with other medicines, such as voriconazole. Background: Many medicines are broken down in the body by enzymes called cytochrome P450 (CYP) enzymes. Read more about this study

Who is it for?
Ages 19 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Drug-Drug Interactions
What is being tested?
Dexamethasone, CYP Probe Cocktail and voriconazole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
No sites listed yet
Study dates
Apr 2026to Jun 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 19 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

[Inclusion Criteria]

  1. Healthy male volunteers aged 19 to 50 years, inclusive, at the time of screening.
  2. Body weight between 50.0 kg and 90.0 kg, and body mass index (BMI) between 18.5 kg/m² and 29.9 kg/m² at the time of screening.
  • BMI (kg/m²) = body weight (kg) / [height (m)]²
  1. Subjects with a CYP2C19 genotype classified as either normal metabolizers (*1/*1) or poor metabolizers (*2/*2, *2/*3, 3/3) based on genotyping results.
  2. Subjects who have received sufficient explanation of the study, fully understood the study procedures, voluntarily agreed to participate, and provided written informed consent prior to any study-related procedures.

[Exclusion Criteria]

  1. Subjects with any clinically significant disease or medical history involving the hepatobiliary, renal, neurological, immunological, respiratory, gastrointestinal, endocrine, hematologic/oncologic, cardiovascular (including heart failure and Torsades de pointes), urogenital, psychiatric (including mood disorders and obsessive-compulsive disorder), or sexual dysfunction systems.
  2. Subjects with a history of gastrointestinal diseases (e.g., Crohn's disease, ulcer, gastritis, gastric spasm, gastroesophageal reflux disease) or gastrointestinal surgery that may affect the safety or pharmacokinetics of the investigational products, except for uncomplicated appendectomy or hernia repair.
  3. Subjects with known hypersensitivity or clinically significant allergic reactions to any components of the investigational products or to other drugs (e.g., aspirin, antibiotics).
  4. Subjects with hereditary disorders, including sucrase-isomaltase deficiency, galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
  5. Subjects who have received any live vaccine within 6 months prior to screening.
  6. Subjects with a history of active infection (including herpes simplex, herpes zoster, varicella, or systemic fungal infection) within 4 weeks prior to screening, or with evidence of ongoing infection at screening.
  7. Subjects without a history of varicella or measles infection and who have not been vaccinated against these diseases.
  8. Subjects with active or latent tuberculosis.
  9. Subjects with positive serologic test results for hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or syphilis.
  10. Subjects with a history of drug abuse or a positive urine drug screening test for drugs of abuse at screening.
  11. Subjects with the following vital sign abnormalities measured in the seated position after at least 3 minutes of rest at screening:
  • Systolic blood pressure ≤ 90 mmHg or ≥ 150 mmHg
  • Diastolic blood pressure ≤ 60 mmHg or ≥ 100 mmHg
  1. Subjects with a QTc interval > 450 msec or any clinically significant abnormal cardiac rhythm on a 12-lead electrocardiogram (ECG) at screening.
  2. Subjects with any of the following clinically significant laboratory abnormalities at screening (including additional confirmatory tests):
  • AST or ALT > 60 IU/L
  • Estimated glomerular filtration rate (eGFR, CKD-EPI equation) < 90 mL/min/1.73 m²
  • Fasting plasma glucose ≥ 126 mg/dL
  1. Subjects who have taken any prescription medications or herbal medicines within 2 weeks, or any over-the-counter medications (OTC), dietary supplements, functional foods, or vitamin products (including liver function supplements) within 1 week prior to the first planned dose of the investigational product, or who are expected to require such products during the study period (except when deemed acceptable by the investigator).
  2. Subjects who have taken enzyme-inducing drugs (e.g., barbiturates) or enzyme-inhibiting drugs (e.g., clarithromycin) within 1 month prior to the first planned dose of the investigational product.
  3. Subjects who have participated in another clinical trial (including bioequivalence studies) and received any investigational product within 6 months prior to the first planned dose.
  4. Subjects who have donated whole blood within 2 months, donated blood components within 1 month, or received a blood transfusion within 6 months prior to the first planned dose.
  5. Current smokers, unless smoking cessation occurred at least 3 months prior to the first planned dose of the investigational product.
  6. Subjects with chronic alcohol consumption exceeding 21 units per week (1 unit = 10 g of pure alcohol), or who are unable to abstain from alcohol from 3 days prior to the first dose until the end of the study.
  7. Subjects with excessive habitual caffeine intake (> 5 units per day; 1 unit = 80 mg caffeine), or who are unable to refrain from consuming caffeine-containing foods and beverages (e.g., coffee, tea, carbonated beverages, coffee milk, tonic drinks, energy drinks) from 3 days prior to the first dose until the end of the study.
  8. Subjects who have consumed grapefruit, grapefruit juice, or grapefruit-containing products from 3 days prior to the first dose until the end of the study, or who are unable to refrain from consuming such products during this period.
  9. Subjects with unusual dietary habits (e.g., consumption of more than 1 L of grapefruit juice per day) or who are unable to consume the standardized meals provided by the study site during the confinement period.
  10. Subjects who do not agree to use condoms, and whose female partners of childbearing potential do not agree to use a highly effective method of contraception from 3 days prior to the first dose until the end of the study. <Highly effective methods of contraception include>
  • Combined hormonal contraception associated with inhibition of ovulation (oral, vaginal, transdermal)
  • Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
  • Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
  • Bilateral tubal occlusion or a vasectomized partner
  • Sexual abstinence, defined as refraining from heterosexual intercourse throughout the entire period of risk
  1. Subjects who do not agree to refrain from sperm donation from 3 days prior to the first dose until the end of the study.
  2. Subjects who are deemed unsuitable for participation in the study at the investigator's discretion for any reason not otherwise specified above.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Soo yeon Lee contact

+82-43-269-8617

sy_lee@cbnuhctc.com

About this study

Official title: A Clinical Study Evaluating the Effects of Dexamethasone on the Activities of CYP2C9, CYP2C19, and CYP3A4 Substrates in Healthy Male Subjects

Purpose:

The purpose of this study is to understand how dexamethasone affects the activity of drug-metabolizing enzymes in the body and how this may influence interactions with other medicines, such as voriconazole.

Read more

Background:

Many medicines are broken down in the body by enzymes called cytochrome P450 (CYP) enzymes. Differences in CYP enzyme activity between individuals can lead to variability in drug response and drug-drug interactions. Dexamethasone is known to affect CYP enzyme activity, and voriconazole is a medication that is metabolized by these enzymes.

Participants:

This study will include a total of 12 healthy adult male volunteers. Participants will be grouped based on their metabolic status, including 6 normal metabolizers (NM) and 6 poor metabolizers (PM).

Interventions:

Participants will receive a combination of probe drugs known as a CYP probe cocktail to assess baseline CYP enzyme activity. Dexamethasone will be administered, and the CYP probe cocktail will be given again to evaluate changes in enzyme activity. Voriconazole will be used to assess the potential for drug-drug interactions related to changes in CYP enzyme activity. Blood samples will be collected during the study.

Outcome Measures:

The main outcomes of this study are changes in blood concentrations of the probe drugs, which reflect changes in CYP enzyme activity, and comparisons of these changes between normal metabolizers and poor metabolizers.

Hypothesis:

The study hypothesizes that dexamethasone alters CYP enzyme activity and that the magnitude of this effect differs between normal metabolizers and poor metabolizers, potentially affecting the metabolism of drugs such as voriconazole.

Read the detailed description

This study is designed as an open-label, single-sequence clinical pharmacology study to evaluate the effects of dexamethasone on cytochrome P450 (CYP) enzyme activity in healthy adult male volunteers.

CYP enzyme activity will be assessed using a validated CYP probe cocktail consisting of multiple probe substrates administered concurrently to evaluate the functional activity of selected CYP isoforms. The probe cocktail will be administered at baseline to characterize individual CYP enzyme activity prior to dexamethasone exposure.

Following baseline assessment, dexamethasone will be administered for a predefined period. After completion of dexamethasone administration, the CYP probe cocktail will be administered again to evaluate changes in CYP enzyme activity induced by dexamethasone. Voriconazole, a CYP-metabolized drug, will be included to assess the potential impact of dexamethasone-induced enzyme modulation on clinically relevant drug-drug interactions.

Serial blood samples will be collected after administration of the probe cocktail and voriconazole to determine pharmacokinetic parameters, including maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC). Changes in these parameters before and after dexamethasone administration will be used as indicators of alterations in CYP enzyme activity.

Participants will be stratified based on CYP2C19 genotype into normal metabolizers (NM) and poor metabolizers (PM). Comparative analyses will be conducted between these groups to explore the influence of genetic polymorphism on dexamethasone-induced changes in CYP enzyme activity.

The results of this study are expected to provide mechanistic insight into dexamethasone-mediated modulation of CYP enzymes and its potential implications for drug-drug interactions involving CYP-metabolized medications.

Being tested
Dexamethasone, CYP Probe Cocktail, voriconazole

What participants receive

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

  • DexamethasoneDrug

    Also called Dexahigh Tablet

    Dexamethasone will be administered orally to evaluate its effect on cytochrome P450 enzyme activity.

  • CYP Probe CocktailDrug

    Also called GL Timing Tablet, Throcul Troche, OMP Tablet, Midazolam Injection

    A CYP probe cocktail composed of approved, commercially available drugs (caffeine, flurbiprofen, omeprazole, and midazolam) will be administered concomitantly as a single-dose cocktail to phenotypically assess cytochrome P450 enzyme activities before and after dexamethasone administration.

  • voriconazoleDrug

    Also called Vfend Tablet

    Voriconazole will be administered to assess drug-drug interactions associated with changes in cytochrome P450 enzyme activity.

Study groups in NCT07426042
Study groupRoleWhat they receive
Single GroupExperimentalA single-arm study in healthy subjects in which voriconazole, a CYP probe cocktail (caffeine, flurbiprofen, omeprazole, and midazolam), and dexamethasone are administered according to the study protocol.
Receives: Drug: Dexamethasone; Drug: CYP Probe Cocktail; Drug: voriconazole

What is being measured

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

  1. Cmax of CYP Probe Substrates(Voriconazole, Midazolam, Omeprazole, Flurbiprofen)

    Cmax of CYP Probe Substrates(Voriconazole, Midazolam, Omeprazole, Flurbiprofen) will be assessed to evaluate the effects of dexamethasone on cytochrome P450 enzyme activity, specifically CYP2C9, CYP2C19, and CYP3A4, in healthy adult male subjects.

    Measured: Up to the last PK sampling time (Period 2 Day 9 for voriconazole; Period 2 Day 8 for midazolam, omeprazole, and flurbiprofen)

  2. AUClast of CYP Probe Substrates(Voriconazole, Midazolam, Omeprazole, Flurbiprofen)

    AUClast of CYP Probe Substrates(Voriconazole, Midazolam, Omeprazole, Flurbiprofen) will be assessed to evaluate the effects of dexamethasone on cytochrome P450 enzyme activity, specifically CYP2C9, CYP2C19, and CYP3A4, in healthy adult male subjects.

    Measured: Up to the last PK sampling time (Period 2 Day 9 for voriconazole; Period 2 Day 8 for midazolam, omeprazole, and flurbiprofen)

  3. AUCinf of CYP Probe Substrates(Voriconazole, Midazolam, Omeprazole, Flurbiprofen)

    AUCinf of CYP Probe Substrates(Voriconazole, Midazolam, Omeprazole, Flurbiprofen) will be assessed to evaluate the effects of dexamethasone on cytochrome P450 enzyme activity, specifically CYP2C9, CYP2C19, and CYP3A4, in healthy adult male subjects.

    Measured: Up to the last PK sampling time (Period 2 Day 9 for voriconazole; Period 2 Day 8 for midazolam, omeprazole, and flurbiprofen)

Secondary outcomes (40)

  1. Tmax of Perpetrator(Dexamethasone)

    Tmax of Perpetrator(Dexamethasone) will be assessed to evaluate the effects of cytochrome P450 enzyme activity, specifically CYP2C9, CYP2C19, and CYP3A4 on dexamethasone, in healthy adult male subjects.

    Measured: Up to the last PK sampling time (Period 2 Day 9 )

  2. Cmax of Perpetrator(Dexamethasone)

    Cmax of Perpetrator(Dexamethasone) will be assessed to evaluate the effects of cytochrome P450 enzyme activity, specifically CYP2C9, CYP2C19, and CYP3A4 on dexamethasone, in healthy adult male subjects.

    Measured: Up to the last PK sampling time (Period 2 Day 9 )

  3. AUCtau of Perpetrator(Dexamethasone)

    AUCtau of Perpetrator(Dexamethasone) will be assessed to evaluate the effects of cytochrome P450 enzyme activity, specifically CYP2C9, CYP2C19, and CYP3A4 on dexamethasone, in healthy adult male subjects.

    Measured: Up to the last PK sampling time (Period 2 Day 9 )

  4. t1/2 of Perpetrator(Dexamethasone)

    t1/2 of Perpetrator(Dexamethasone) will be assessed to evaluate the effects of cytochrome P450 enzyme activity, specifically CYP2C9, CYP2C19, and CYP3A4 on dexamethasone, in healthy adult male subjects.

    Measured: Up to the last PK sampling time (Period 2 Day 9 )

  5. CL/F of Perpetrator(Dexamethasone)

    CL/F of Perpetrator(Dexamethasone) will be assessed to evaluate the effects of cytochrome P450 enzyme activity, specifically CYP2C9, CYP2C19, and CYP3A4 on dexamethasone, in healthy adult male subjects.

    Measured: Up to the last PK sampling time (Period 2 Day 9 )

  6. Vz/F of Perpetrator(Dexamethasone)

    Vz/F of Perpetrator(Dexamethasone) will be assessed to evaluate the effects of cytochrome P450 enzyme activity, specifically CYP2C9, CYP2C19, and CYP3A4 on dexamethasone, in healthy adult male subjects.

    Measured: Up to the last PK sampling time (Period 2 Day 9 )

  7. Tmax,ss of Perpetrator(Dexamethasone)

    Tmax,ss of Perpetrator(Dexamethasone) will be assessed to evaluate the effects of cytochrome P450 enzyme activity, specifically CYP2C9, CYP2C19, and CYP3A4 on dexamethasone, in healthy adult male subjects.

    Measured: Up to the last PK sampling time (Period 2 Day 9 )

  8. Cmax,ss of Perpetrator(Dexamethasone)

    Cmax,ss of Perpetrator(Dexamethasone) will be assessed to evaluate the effects of cytochrome P450 enzyme activity, specifically CYP2C9, CYP2C19, and CYP3A4 on dexamethasone, in healthy adult male subjects.

    Measured: Up to the last PK sampling time (Period 2 Day 9 )

  9. Cmin,ss of Perpetrator(Dexamethasone)

    Cmin,ss of Perpetrator(Dexamethasone) will be assessed to evaluate the effects of cytochrome P450 enzyme activity, specifically CYP2C9, CYP2C19, and CYP3A4 on dexamethasone, in healthy adult male subjects.

    Measured: Up to the last PK sampling time (Period 2 Day 9 )

  10. Cavg,ss of Perpetrator(Dexamethasone)

    Cavg,ss of Perpetrator(Dexamethasone) will be assessed to evaluate the effects of cytochrome P450 enzyme activity, specifically CYP2C9, CYP2C19, and CYP3A4 on dexamethasone, in healthy adult male subjects.

    Measured: Up to the last PK sampling time (Period 2 Day 9 )

  11. AUCtau,ss of Perpetrator(Dexamethasone)

    AUCtau,ss of Perpetrator(Dexamethasone) will be assessed to evaluate the effects of cytochrome P450 enzyme activity, specifically CYP2C9, CYP2C19, and CYP3A4 on dexamethasone, in healthy adult male subjects.

    Measured: Up to the last PK sampling time (Period 2 Day 9 )

  12. t1/2,ss of Perpetrator(Dexamethasone)

    t1/2,ss of Perpetrator(Dexamethasone) will be assessed to evaluate the effects of cytochrome P450 enzyme activity, specifically CYP2C9, CYP2C19, and CYP3A4 on dexamethasone, in healthy adult male subjects.

    Measured: Up to the last PK sampling time (Period 2 Day 9 )

  13. CLss/F of Perpetrator(Dexamethasone)

    CLss/F of Perpetrator(Dexamethasone) will be assessed to evaluate the effects of cytochrome P450 enzyme activity, specifically CYP2C9, CYP2C19, and CYP3A4 on dexamethasone, in healthy adult male subjects.

    Measured: Up to the last PK sampling time (Period 2 Day 9 )

  14. Vzss/F of Perpetrator(Dexamethasone)

    Vzss/F of Perpetrator(Dexamethasone) will be assessed to evaluate the effects of cytochrome P450 enzyme activity, specifically CYP2C9, CYP2C19, and CYP3A4 on dexamethasone, in healthy adult male subjects.

    Measured: Up to the last PK sampling time (Period 2 Day 9 )

  15. Tmax of CYP Probe Substrates(Voriconazole, Midazolam, Omeprazole, Flurbiprofen)

    Tmax of CYP Probe Substrates(Voriconazole, Midazolam, Omeprazole, Flurbiprofen) will be assessed to evaluate the effects of dexamethasone on cytochrome P450 enzyme activity, specifically CYP2C9, CYP2C19, and CYP3A4, in healthy adult male subjects.

    Measured: Up to the last PK sampling time (Period 2 Day 9 for voriconazole; Period 2 Day 8 for midazolam, omeprazole, and flurbiprofen)

  16. t1/2 of CYP Probe Substrates(Voriconazole, Midazolam, Omeprazole, Flurbiprofen)

    t1/2 of CYP Probe Substrates(Voriconazole, Midazolam, Omeprazole, Flurbiprofen) will be assessed to evaluate the effects of dexamethasone on cytochrome P450 enzyme activity, specifically CYP2C9, CYP2C19, and CYP3A4, in healthy adult male subjects.

    Measured: Up to the last PK sampling time (Period 2 Day 9 for voriconazole; Period 2 Day 8 for midazolam, omeprazole, and flurbiprofen)

  17. CL/F of CYP Probe Substrates(Voriconazole, Omeprazole, Flurbiprofen)

    CL/F of CYP Probe Substrates(Voriconazole, Omeprazole, Flurbiprofen) will be assessed to evaluate the effects of dexamethasone on cytochrome P450 enzyme activity, specifically CYP2C9 and CYP2C19, in healthy adult male subjects.

    Measured: Up to the last PK sampling time (Period 2 Day 9 for voriconazole; Period 2 Day 8 for omeprazole, and flurbiprofen)

  18. CL of CYP Probe Substrates(Midazolam)

    CL of CYP Probe Substrates(Midazolam) will be assessed to evaluate the effects of dexamethasone on cytochrome P450 enzyme activity, specifically CYP3A4, in healthy adult male subjects.

    Measured: Up to the last PK sampling time (Period 2 Day 8 for midazolam)

  19. Vz of CYP Probe Substrates(Midazolam)

    Vz of CYP Probe Substrates(Midazolam) will be assessed to evaluate the effects of dexamethasone on cytochrome P450 enzyme activity, specifically CYP3A4, in healthy adult male subjects.

    Measured: Up to the last PK sampling time (Period 2 Day 8 for midazolam)

  20. Vz/F of CYP Probe Substrates(Voriconazole, Omeprazole, Flurbiprofen)

    Vz/F of CYP Probe Substrates(Voriconazole, Omeprazole, Flurbiprofen) will be assessed to evaluate the effects of dexamethasone on cytochrome P450 enzyme activity, specifically CYP2C9 and CYP2C19, in healthy adult male subjects.

    Measured: Up to the last PK sampling time (Period 2 Day 9 for voriconazole; Period 2 Day 8 for omeprazole, and flurbiprofen)

  21. Metabolic ratio of CYP Probe Substrates(Voriconazole, Midazolam, Omeprazole, Flurbiprofen)

    Metabolic ratio of CYP Probe Substrates(Voriconazole, Midazolam, Omeprazole, Flurbiprofen) will be assessed to evaluate the effects of dexamethasone on cytochrome P450 enzyme activity, specifically CYP2C9, CYP2C19, and CYP3A4, in healthy adult male subjects.

    Measured: Up to the last PK sampling time (Period 2 Day 9 for voriconazole; Period 2 Day 8 for midazolam, omeprazole, and flurbiprofen)

  22. Tmax of Metabolite(Voriconazole N-oxide, 1'-OH-midazolam, 5'-OH-omeprazole, 4'-OH-flurbiprofen)

    Tmax of metabolites (Voriconazole N-oxide, 1'-OH-midazolam, 5'-OH-omeprazole, and 4'-OH-flurbiprofen) will be assessed in healthy adult male subjects.

    Measured: Up to the last PK sampling time (Period 2 Day 9 for Voriconazole N-oxide; Period 2 Day 8 for 1'-OH-midazolam, 5'-OH-omeprazole, 4'-OH-flurbiprofen)

  23. Cmax of Metabolite(Voriconazole N-oxide, 1'-OH-midazolam, 5'-OH-omeprazole, 4'-OH-flurbiprofen)

    Cmax of metabolites (Voriconazole N-oxide, 1'-OH-midazolam, 5'-OH-omeprazole, and 4'-OH-flurbiprofen) will be assessed in healthy adult male subjects.

    Measured: Up to the last PK sampling time (Period 2 Day 9 for Voriconazole N-oxide; Period 2 Day 8 for 1'-OH-midazolam, 5'-OH-omeprazole, 4'-OH-flurbiprofen)

  24. AUClast of Metabolite(Voriconazole N-oxide, 1'-OH-midazolam, 5'-OH-omeprazole, 4'-OH-flurbiprofen)

    AUClast of metabolites (Voriconazole N-oxide, 1'-OH-midazolam, 5'-OH-omeprazole, and 4'-OH-flurbiprofen) will be assessed in healthy adult male subjects.

    Measured: Up to the last PK sampling time (Period 2 Day 9 for Voriconazole N-oxide; Period 2 Day 8 for 1'-OH-midazolam, 5'-OH-omeprazole, 4'-OH-flurbiprofen)

  25. AUCinf of Metabolite(Voriconazole N-oxide, 1'-OH-midazolam, 5'-OH-omeprazole, 4'-OH-flurbiprofen)

    AUCinf of metabolites (Voriconazole N-oxide, 1'-OH-midazolam, 5'-OH-omeprazole, and 4'-OH-flurbiprofen) will be assessed in healthy adult male subjects.

    Measured: Up to the last PK sampling time (Period 2 Day 9 for Voriconazole N-oxide; Period 2 Day 8 for 1'-OH-midazolam, 5'-OH-omeprazole, 4'-OH-flurbiprofen)

  26. t1/2 of Metabolite(Voriconazole N-oxide, 1'-OH-midazolam, 5'-OH-omeprazole, 4'-OH-flurbiprofen)

    t1/2 of metabolites (Voriconazole N-oxide, 1'-OH-midazolam, 5'-OH-omeprazole, and 4'-OH-flurbiprofen) will be assessed in healthy adult male subjects.

    Measured: Up to the last PK sampling time (Period 2 Day 9 for Voriconazole N-oxide; Period 2 Day 8 for 1'-OH-midazolam, 5'-OH-omeprazole, 4'-OH-flurbiprofen)

  27. 12-lead electrocardiograms

    Assessment of the electrical activity of the heart to monitor cardiac safety, including intervals such as PR, QRS, QT, and QTc

    Measured: From enrollment up to Day 12 in Period 2(EOS)

  28. physical examinations

    Assessment of the subject's physical condition across all major body systems to evaluate safety and identify any clinically significant changes

    Measured: From enrollment up to Day 12 in Period 2(EOS)

  29. oxygen saturation

    Measurement of blood oxygen saturation levels using a pulse oximeter to monitor safety.

    Measured: From enrollment up to Day 12 in Period 2(EOS)

  30. sedation assessments

    Assessment of the subject's status according to the Observer's Assessment of Alertness/Sedation (OAA/S) scale.

    Measured: From enrollment up to Day 12 in Period 2(EOS)

  31. adverse events

    Monitoring and recording of all treatment-emergent adverse events (TEAEs) through spontaneous reporting and investigator observation.

    Measured: From enrollment up to Day 12 in Period 2(EOS)

  32. Systolic Blood Pressure

    Systolic blood pressure will be monitored to assess subject safety.

    Measured: From enrollment up to Day 12 in Period 2 Day 9

  33. Diastolic Blood Pressure

    Diastolic blood pressure will be monitored to assess subject safety.

    Measured: From enrollment up to Day 12 in Period 2 Day 9

  34. Pulse Rate

    Pulse rate will be monitored to assess subject safety.

    Measured: From enrollment up to Day 12 in Period 2 Day 9

  35. Respiratory rate

    Respiratory rate will be monitored to assess subject safety.

    Measured: From enrollment up to Day 12 in Period 2 Day 9

  36. Body Temperature

    Body temperature will be monitored to assess subject safety.

    Measured: From enrollment up to Day 12 in Period 2 Day 9

  37. Hematology

    Hematology tests(including WBC, RBC, Hemoglobin, Hematocrit, Platelet) will be evaluated to assess subject safety throughout the study period.

    Measured: From enrollment up to Day 12 in Period 2 Day 9

  38. Blood Chemistry

    Blood chemistry tests (including Calcium, Phosphorus, Glucose, BUN, Uric acid, Cholesterol, Protein, Albumin, Bilirubin total, ALP, AST, ALT, γ-GT, CPK, LDH, Creatinine, eGFR, Sodium, Potassium, Chloride, Triglyceride, hs-CRP ) will be evaluated to assess subject safety throughout the study period.

    Measured: From enrollment up to Day 12 in Period 2 Day 9

  39. Coagulation

    Coagulation tests (including PT(INR), aPTT) will be evaluated to assess subject safety throughout the study period.

    Measured: From enrollment up to Day 12 in Period 2 Day 9

  40. Urinalysis

    Urinalysis tests (including Dipstick(Color, pH, Specific Gravity, Protein, Bilirubin, Glucose, Urobilinogen, Ketone, Nitrite, Blood, WBC)) will be evaluated to assess subject safety throughout the study period.

    Measured: From enrollment up to Day 12 in Period 2 Day 9

Timeline

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

  1. First posted23 Feb 2026
  2. Study startApr 2026 (estimated)
  3. Primary completionMay 2026 (estimated)
  4. Study completionJun 2026 (estimated)

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07426042
Sponsor's protocol ID
Dexamethasone_cocktail
Status last verified
Jan 2026
First submitted
31 Dec 2025
Last updated
23 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared because this is an investigator-initiated, exploratory pharmacokinetic drug-drug interaction study conducted in a limited number of healthy volunteers. The collected data are intended for predefined analyses only, and no data sharing plan has been established.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dexamethasone, CYP Probe Cocktail and voriconazole in people with Drug-Drug Interactions, run by Min Kyu Park.

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

Who may be eligible to take part?

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: opening soon, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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

Contact Soo yeon Lee (+82-43-269-8617, sy_lee@cbnuhctc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax of CYP Probe Substrates(Voriconazole, Midazolam, Omeprazole, Flurbiprofen) (time frame: Up to the last PK sampling time (Period 2 Day 9 for voriconazole; Period 2 Day 8 for midazolam, omeprazole, and flurbiprofen)). The study lists 3 primary outcomes in all. 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 NCT07426042.

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 23 Feb 2026.

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