Drug InteractionPhase 1NCT05575297
A Drug-drug Interaction Study to Evaluate the Effect of Rifampicin and Febuxostat on the Pharmacokinetics of Methotrexate in Healthy Subjects
A Phase 1 study testing Methotrexate Sodium, Rifampicin Sodium and Febuxostat Tablets in people with Drug Interaction, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To investigate the effect of rifampicin and febuxostat on pharmacokinetics of methotrexate in healthy volunteers Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Drug Interaction
- What is being tested?
- Methotrexate Sodium, Rifampicin Sodium and Febuxostat Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Dec 2021to 9 May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the effect of rifampicin and febuxostat on pharmacokinetics of methotrexate in healthy volunteers
- Conditions
- Drug Interaction
- Being tested
- Methotrexate Sodium, Rifampicin Sodium, Febuxostat Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methotrexate SodiumDrug
Methotrexate oral administration alone
Rifampicin SodiumDrug
Co-administration of methotrexate and rifampicin
Febuxostat TabletsDrug
Co-administration of methotrexate and febuxostat
| Study group | Role | What they receive |
|---|---|---|
| Methotrexate | Experimental | Not described Receives: Drug: Methotrexate Sodium |
| Methotrexate + Rifampicin | Experimental | Methotrexate + Rifampicin Receives: Drug: Methotrexate Sodium; Drug: Rifampicin Sodium |
| Methotrexate + Febuxostat | Experimental | Methotrexate + Febuxostat Receives: Drug: Methotrexate Sodium; Drug: Febuxostat Tablets |
| Methotrexate + Rifampicin + Febuxostat | Experimental | Methotrexate + Rifampicin + Febuxostat Receives: Drug: Methotrexate Sodium; Drug: Rifampicin Sodium; Drug: Febuxostat Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Cmax of methotrexate
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
Measured: 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 AUClast of methotrexate
Compare the area under the plasma concentration-time curve to from 0 to last measurable time point (AUClast) of methotrexate
Measured: 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 AUCinf of methotrexate
Compare area under the plasma concentration-time curve from 0 hours to infinite time (AUCinf) of methotrexate
Measured: 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 (3)
Compare Cmax of 7-hydroxy methotrexate
Compare the maximum concentration (Cmax) of 7-hydroxy methotrexate
Measured: 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 AUClast of 7-hydroxy methotrexate
Compare area under the plasma concentration-time curve to last measurable time point (AUClast) of 7-hydroxy methotrexate
Measured: 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 AUCinf of 7-hydroxy methotrexate
Compare area under the plasma concentration-time curve from 0 hours to infinite time (AUCinf) of 7-hydroxy methotrexate
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start20 Dec 2021
- Primary completion3 May 2022
- Study completion9 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug InteractionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae Yong Chung, MD, PhD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575297
- Sponsor's protocol ID
- MRFI
- Status last verified
- Oct 2022
- First submitted
- 4 Oct 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hwang S, Lee Y, Jang Y, Cho JY, Yoon S, Chung JY. Comprehensive Evaluation of OATP- and BCRP-Mediated Drug-Drug Interactions of Methotrexate Using Physiologically-Based Pharmacokinetic Modeling. Clin Pharmacol Ther. 2024 Oct;116(4):1013-1022. doi: 10.1002/cpt.3329. Epub 2024 Jun 11.
PubMed 38860384
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Drug-drug Interaction Study to Evaluate the Effect of Rifampicin and Febuxostat on the Pharmacokinetics of Methotrexate in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05575297
- Acronym / sponsor ID
- MRFI
- Conditions
- Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 3 May 2022 (actual)
- Study completion
- 9 May 2022 (actual)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effect of rifampicin and febuxostat on pharmacokinetics of methotrexate in healthy volunteers
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Methotrexate | Experimental | Drug: Methotrexate Sodium |
| Methotrexate + Rifampicin | Experimental | Drug: Methotrexate Sodium, Drug: Rifampicin SodiumMethotrexate + Rifampicin |
| Methotrexate + Febuxostat | Experimental | Drug: Methotrexate Sodium, Drug: Febuxostat TabletsMethotrexate + Febuxostat |
| Methotrexate + Rifampicin + Febuxostat | Experimental | Drug: Methotrexate Sodium, Drug: Rifampicin Sodium, Drug: Febuxostat TabletsMethotrexate + Rifampicin + Febuxostat |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methotrexate SodiumMethotrexate oral administration alone | Drug | Methotrexate, Methotrexate + Febuxostat, Methotrexate + Rifampicin, Methotrexate + Rifampicin + Febuxostat |
| Rifampicin SodiumCo-administration of methotrexate and rifampicin | Drug | Methotrexate + Rifampicin, Methotrexate + Rifampicin + Febuxostat |
| Febuxostat TabletsCo-administration of methotrexate and febuxostat | Drug | Methotrexate + Febuxostat, Methotrexate + Rifampicin + Febuxostat |
Primary outcome
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
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
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
3 secondary outcomes
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 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 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Derived from this study: PubMed 38860384Hwang S, Lee Y, Jang Y, Cho JY, Yoon S, Chung JY. Comprehensive Evaluation of OATP- and BCRP-Mediated Drug-Drug Interactions of Methotrexate Using Physiologically-Based Pharmacokinetic Modeling. Clin Pharmacol Ther. 2024 Oct;116(4):1013-1022. doi: 10.1002/cpt.3329. Epub 2024 Jun 11.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Methotrexate Sodium, Rifampicin Sodium and Febuxostat Tablets in people with Drug Interaction, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. 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: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). 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 NCT05575297, which also lists 1 linked publication.
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 12 Oct 2022.