Common steroid may change how other drugs work
NCT ID NCT07426042
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early-stage study will give 12 healthy men dexamethasone to see how it changes the activity of key drug-metabolizing enzymes. Participants will also take a cocktail of probe drugs and voriconazole to measure these effects. The goal is to understand potential drug interactions, which could help make prescribing safer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dexamethasone
- What this could lead to
- If successful, this study could help doctors predict and avoid harmful drug interactions when prescribing dexamethasone with other medications.
- What could go wrong
- This is a very early, small study in only 12 healthy men, so results may not apply to women or people with illnesses. It measures enzyme activity, not direct patient outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 to 50 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
\[Inclusion Criteria\] 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 3. 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. 4. 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 12. Subjects with a QTc interval \> 450 msec or any clinically significant abnormal cardiac rhythm on a 12-lead electrocardiogram (ECG) at screening. 13. 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 14. 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). 15. 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. 16. 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. 17. 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. 18. Current smokers, unless smoking cessation occurred at least 3 months prior to the first planned dose of the investigational product. 19. 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. 20. 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. 21. 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. 22. 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. 23. 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 24. Subjects who do not agree to refrain from sperm donation from 3 days prior to the first dose until the end of the study. 25. Subjects who are deemed unsuitable for participation in the study at the investigator's discretion for any reason not otherwise specified above.
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As listed by the trial registrant
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How to take part
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The official record
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