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Completed

NCT Number: NCT05575297

A Drug-drug Interaction Study to Evaluate the Effect of Rifampicin and Febuxostat on the Pharmacokinetics of Methotrexate in Healthy Subjects

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

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Key information

Conditions

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Bundang Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methotrexate Sodium

Drug

Methotrexate oral administration alone

Rifampicin Sodium

Drug

Co-administration of methotrexate and rifampicin

Febuxostat Tablets

Drug

Co-administration of methotrexate and febuxostat

Primary outcomes

  1. Compare Cmax of methotrexate

    Time frame: 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)

    Compare the maximum concentration (Cmax), area under the plasma concentration-time curve to last measurable time point (AUClast) and area under the plasma concentration-time curve from 0 hours to infinite time (AUCinf) of methotrexate

  2. Compare AUClast of methotrexate

    Time frame: 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)

    Compare the area under the plasma concentration-time curve to from 0 to last measurable time point (AUClast) of methotrexate

  3. Compare AUCinf of methotrexate

    Time frame: 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)

    Compare area under the plasma concentration-time curve from 0 hours to infinite time (AUCinf) of methotrexate

Secondary outcomes

  1. Compare Cmax of 7-hydroxy methotrexate

    Time frame: 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)

    Compare the maximum concentration (Cmax) of 7-hydroxy methotrexate

  2. Compare AUClast of 7-hydroxy methotrexate

    Time frame: 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)

    Compare area under the plasma concentration-time curve to last measurable time point (AUClast) of 7-hydroxy methotrexate

  3. Compare AUCinf of 7-hydroxy methotrexate

    Time frame: 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)

    Compare area under the plasma concentration-time curve from 0 hours to infinite time (AUCinf) of 7-hydroxy methotrexate

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 12, 2022
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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