Clinical trial NCT05575297: A Drug-drug Interaction Study to Evaluate the Effect of Rifampicin and Febuxostat on the Pharmacokinetics of Methotrexate in Healthy Subjects
Official title: A Drug-drug Interaction Study to Evaluate the Effect of Rifampicin and Febuxostat on the Pharmacokinetics of Methotrexate in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Interaction
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 12
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate the effect of rifampicin and febuxostat on pharmacokinetics of methotrexate in healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Age between 19 to 50, healthy male subjects (at screening)
* Body weight between 50.0 kg - 90.0 kg, BMI between 18.0 - 30.0 kg/m2
* Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress

Exclusion Criteria:

* Subject who has a past or present history of any diseases (eg. liver, kidney, neurology, immunology, pulmonary, endocrine, hematology, oncology, cardiology, mental disorder)
* Subject who had GI tract disease (Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery (appendectomy, hernioplasty are excluded)
* Serum AST(SGOT), ALT(SGPT), total bilirubin \>1.5 times upper limit of normal range, MDRD eGFR \< 60mL/min/1.73m2, WBC count \< 3,500 /uL, SBP \< 90 mmHg or \> 150 mmHg, DBP \< 50 mmHg or \>100 mmHg
* Subject who had galactose intolerance, Lapplactase deficiency or glucose-galactose malabsorption
* Subject who had received drugs inhibiting or inducing metabolic enzymes/transporters such as barbiturates, statins, digoxin in 3 months
* Subject who had taken St.John's wort and food including grapefruit in 2 weeks
* Smoking in 3 months
* Subject who had whole blood donation in 2 months, or component blood donation in 1 month or transfusion in 1 month currently

Primary outcomes:
measure: Compare Cmax of methotrexate
timeFrame: pre-dose (0h), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24 h post-dose (Period 1, 2, 3, 4 Day 1)
measure: Compare AUClast of methotrexate
timeFrame: pre-dose (0h), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24 h post-dose (Period 1, 2, 3, 4 Day 1)
measure: Compare AUCinf of methotrexate
timeFrame: pre-dose (0h), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24 h post-dose (Period 1, 2, 3, 4 Day 1)
Secondary outcomes:
measure: Compare Cmax of 7-hydroxy methotrexate
timeFrame: pre-dose (0h), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24 h post-dose (Period 1, 2, 3, 4 Day 1)
measure: Compare AUClast of 7-hydroxy methotrexate
timeFrame: pre-dose (0h), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24 h post-dose (Period 1, 2, 3, 4 Day 1)
measure: Compare AUCinf of 7-hydroxy methotrexate
timeFrame: pre-dose (0h), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24 h post-dose (Period 1, 2, 3, 4 Day 1)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
References: