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

NCT06108453 | Unknown Phase 1

• 1 other identifier: MRIE
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Drug Interactions

Outcome Measures

Primary Outcomes (3)

• Compare Cmax of methotrexate

  Compare the maximum concentration (Cmax) of methotrexate

  pre-dose (0h), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24 h post-dose (Period 1, 2 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

  pre-dose (0h), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24 h post-dose (Period 1, 2 Day 1)

• Compare AUCinf of methotrexate

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

  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)

• Compare Cmax of 7-hydroxy methotrexate

  pre-dose (0h), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24 h post-dose (Period 1, 2 Day 1)

• Compare AUClast of 7-hydroxy methotrexate

  pre-dose (0h), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24 h post-dose (Period 1, 2 Day 1)

• Compare AUCinf of 7-hydroxy methotrexate

  pre-dose (0h), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24 h post-dose (Period 1, 2 Day 1)

Study Arms (2)

Methotrexate

EXPERIMENTAL

Drug: Methotrexate Sodium

Methotrexate + Rifampicin

EXPERIMENTAL

Methotrexate + Rifampicin

Drug: Methotrexate Sodium; Drug: Rifampicin

Interventions

Methotrexate Sodium DRUG

Methotrexate oral administration alone

Methotrexate; Methotrexate + Rifampicin

Rifampicin DRUG

Co-administration of methotrexate and rifampicin

Methotrexate + Rifampicin

Eligibility Criteria

• Age: 70 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Location

MeSH Terms

Interventions

Methotrexate; Rifampin

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: August 21, 2023
• Primary Completion: October 24, 2024
• Study Completion: November 24, 2024
• Last Updated: October 31, 2023

Record last verified: 2023-10

Locations

KR (1)