Drug-Drug Interaction of Rifampicin and Cyclosporine on Methotrexate Pharmacokinetics in Healthy … (NCT07196449) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Drug-Drug Interaction of Rifampicin and Cyclosporine on Methotrexate Pharmacokinetics in Healthy Subjects
South Korea12 participantsStarted 2025-05-14
Plain-language summary
This study will evaluate how methotrexate is processed in the body when given with low doses of rifampicin or cyclosporine. These drugs may affect how methotrexate is absorbed and cleared, which could change its safety and effectiveness. Healthy volunteers will receive methotrexate with either rifampicin or cyclosporine, and blood samples will be collected to measure drug levels. The findings may help identify possible drug interactions and improve the safe use of methotrexate.
Who can participate
Age range19 Years – 45 Years
SexMALE
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Inclusion criteria
✓. Healthy adult male volunteers aged between 19 and 45 years (inclusive) at the time of screening visit.
✓. Body weight between 50.0 kg and 90.0 kg (inclusive) and a body mass index (BMI) between 18.0 and 30.0 kg/m² (inclusive) at the time of screening.
✓. Judged by the investigator to be suitable for participation in the study based on physical examination, clinical laboratory tests, and medical history.
✓. Willingly provided written informed consent to participate after receiving and fully understanding a detailed explanation of the study prior to any screening procedures.
Exclusion criteria
✕. Individuals with clinically significant hepatic (e.g., biliary obstruction), renal, neurologic, immunologic, gastrointestinal (e.g., irritable bowel syndrome, constipation), respiratory, endocrine disorders, or hematologic/oncologic, cardiovascular, or psychiatric disorders (e.g., mood disorders, obsessive-compulsive disorder), or relevant medical history.
✕. History of clinically significant hypersensitivity to the investigational product, drugs in the same class, or other medications (e.g., aspirin, antibiotics) or food products.
✕. History of gastrointestinal diseases (e.g., Crohn's disease, peptic ulcer) or surgeries that may affect drug absorption (except for simple appendectomy or hernia repair).
✕. Known hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
✕. Subjects meeting any of the following criteria at screening: AST(SGOT) or ALT(SGPT) \> 1.5 × upper limit of normal (ULN); eGFR \< 80 mL/min/1.73m² (calculated using CKD-EPI equation); QTc interval \> 450 ms; Sitting blood pressure after ≥3 minutes of rest: systolic \< 90 mmHg or \> 150 mmHg, or diastolic \< 50 mmHg or \> 100 mmHg.
What they're measuring
1
MTX Cmax
Timeframe: pre-dose (0 hours), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, and 24 hours post-dose for each period (11 time points per period)
2
MTX AUClast
Timeframe: pre-dose (0 hours), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, and 24 hours post-dose for each period (11 time points per period)