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Drug InteractionsPhase 1NCT06108453

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

A Phase 1 study testing Methotrexate Sodium and Rifampicin in people with Drug Interactions, run by Seoul National University Bundang Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To investigate the effect of rifampicin on the pharmacokinetics of methotrexate. Read more about this study

Who is it for?
Ages 70 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Drug Interactions
What is being tested?
Methotrexate Sodium and Rifampicin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteSouth Korea
Study dates
21 Aug 2023to 24 Nov 2024
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 70 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Healthy elderly volunteers aged 70 to 80 years at the time of screening visit
  • Those whose weight is between 50.0 kg and 90.0 kg and whose BMI (kg/m2) is between 18.0 and 30.0 at the time of screening visit
  • ※ BMI(Body mass index) = Weight (kg) / {Height (m2)}
  • Those who are suitable as test subjects for this test as determined by the investigator through physical examination, clinical laboratory performance examination, and questionnaire, etc.
  • Those who voluntarily decided to participate and agreed in writing to follow the precautions after receiving a detailed explanation of this clinical trial and fully understanding it before the screening test

Who cannot join

  • Those with clinical evidence of significant respiratory, circulatory, kidney, gastrointestinal, liver, endocrine, blood, nerve (including ataxia), mental or other chronic diseases, alcohol or drug addiction within one year from the start date of the clinical trial (However, currently well-controlled hypertension, hyperlipidemia, arthritis, benign prostatic hyperplasia (mild), and cataracts (if surgery is performed) may be selected at the discretion of the investigator.)
  • Persons with a history of clinically significant hypersensitivity to clinical investigational drug ingredients or drugs containing ingredients of the same class, or other drugs (aspirin, antibiotics, etc.) or food
  • Those with a history of gastrointestinal disease (e.g. Crohn's disease, ulcer, etc.) or surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of the investigational drug
  • People with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
  • Those who showed the following results in the screening test:
  • Blood AST (SGOT), ALT (SGPT), total bilirubin: > 1.5 times the upper limit of normal range
Show all 20Show fewer
  • WBC count < 3,500 /μL
  • eGFR (MDRD equation) < 60 mL/min/1.73 m2
  • Those who test positive for hepatitis B, hepatitis C, HIV, or syphilis in the screening test
  • Those with a history of drug abuse or who tested positive for drugs of abuse in a urine screening test
  • Those who drink alcohol continuously (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the clinical trial period
  • Those who tested positive in the alcohol breath test at the time of the screening test
  • Those who are unable to stop smoking during the entire clinical trial period, starting from 3 months before the scheduled date of first administration of the investigational drug
  • Those who have taken drugs with known significant drug interactions or drugs that are deemed unsuitable by the investigator within 14 days of administering the investigational drug (however, those who can take a break from medication for 7 days before administration and during the hospitalization period are excluded)
  • Persons who cannot refrain from consuming foods containing St. John's Wort or grapefruit during the entire clinical trial period, starting 14 days before the scheduled date of first administration of the investigational drug.
  • Persons who have continuously consumed excessive caffeine (>5 units/day) or who cannot refrain from consuming caffeine/caffeine-containing foods (coffee, tea, nutrient tonic drink drinks, etc.) during the entire clinical trial period from 7 days prior to the scheduled date of first administration of the investigational drug
  • Those who have taken prescription drugs or herbal medicine within 2 weeks before the first administration date, or who have taken over-the-counter drugs (OTC) or health functional foods within 7 days (however, if other conditions are appropriate according to the judgment of the investigator, participation in the clinical trial can participate)
  • A person who has participated in a clinical trial targeting other healthy people within at least 6 months prior to conducting the relevant clinical trial
  • Those who have donated whole blood or component blood within 1 month within 2 months before the scheduled date of first administration of the investigational drug, or who have received a blood transfusion within 1 month
  • Persons judged by the investigator to be unsuitable for participation in this clinical trial due to clinical laboratory test results or other reasons

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Bundang Hospital

    Gyeonggi-do

Other trials in South Korea

About this study

To investigate the effect of rifampicin on the pharmacokinetics of methotrexate.

Being tested
Methotrexate Sodium, Rifampicin

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

  • RifampicinDrug

    Co-administration of methotrexate and rifampicin

Study groups in NCT06108453
Study groupRoleWhat they receive
MethotrexateExperimentalNot described
Receives: Drug: Methotrexate Sodium
Methotrexate + RifampicinExperimentalMethotrexate + Rifampicin
Receives: Drug: Methotrexate Sodium; Drug: Rifampicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare Cmax of methotrexate

    Compare the maximum concentration (Cmax) 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 Day 1)

  2. 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 Day 1)

  3. 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 Day 1)

Secondary outcomes (3)

  1. Compare Cmax of 7-hydroxy methotrexate

    Compare the maximum concentration (Cmax) 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 Day 1)

  2. 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 Day 1)

  3. 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 Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2023
  2. Study start21 Aug 2023
  3. Primary completion24 Oct 2024 (estimated)
  4. Study completion24 Nov 2024 (estimated)

Resources

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
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06108453
Sponsor's protocol ID
MRIE
Status last verified
Oct 2023
First submitted
25 Oct 2023
Last updated
31 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Methotrexate Sodium and Rifampicin in people with Drug Interactions, run by Seoul National University Bundang 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 5 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 31 Oct 2023. 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?

Results are not available in the source record.

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 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 NCT06108453.

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 31 Oct 2023.

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