NCT05575297

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2022

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 12, 2022

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2022

Enrollment Period

4 months

First QC Date

October 4, 2022

Last Update Submit

October 10, 2022

Conditions

Drug Interaction

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    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

    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

    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

    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)

Study Arms (4)

Methotrexate

EXPERIMENTAL
Drug: Methotrexate Sodium

Methotrexate + Rifampicin

EXPERIMENTAL

Methotrexate + Rifampicin

Drug: Methotrexate SodiumDrug: Rifampicin Sodium

Methotrexate + Febuxostat

EXPERIMENTAL

Methotrexate + Febuxostat

Drug: Methotrexate SodiumDrug: Febuxostat Tablets

Methotrexate + Rifampicin + Febuxostat

EXPERIMENTAL

Methotrexate + Rifampicin + Febuxostat

Drug: Methotrexate SodiumDrug: Rifampicin SodiumDrug: Febuxostat Tablets

Interventions

Methotrexate SodiumDRUG

Methotrexate oral administration alone

MethotrexateMethotrexate + FebuxostatMethotrexate + RifampicinMethotrexate + Rifampicin + Febuxostat
Rifampicin SodiumDRUG

Co-administration of methotrexate and rifampicin

Methotrexate + RifampicinMethotrexate + Rifampicin + Febuxostat
Febuxostat TabletsDRUG

Co-administration of methotrexate and febuxostat

Methotrexate + FebuxostatMethotrexate + Rifampicin + Febuxostat

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

MethotrexateFebuxostat

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-Ring

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 4, 2022

First Posted

October 12, 2022

Study Start

December 20, 2021

Primary Completion

May 3, 2022

Study Completion

May 9, 2022

Last Updated

October 12, 2022

Record last verified: 2022-10

Locations

KR(1)