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Aminopterin Pharmacokinetic Study In Moderate to Severe Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Aminopterin Pharmacokinetic Study In Moderate to Severe Psoriasis

A Randomized Phase 1 Study Comparing The Safety and Oral Pharmacokinetics Of 0.25 mg and 1.0 mg Aminopterin Tablets In Human Subjects With Psoriasis

NCT00937027•Syntrix Biosystems, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the safety and pharmacokinetic properties (the absorption, distribution and excretion) of two preparations of aminopterin (0.25 mg tablets and 1.0 mg tablets) following oral administration by subjects with moderate to severe psoriasis.

Eligibility

Age

21 - 59 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Give written informed consent by signing an IRB-approved Informed Consent.
•Be under treatment for at least moderate to severe psoriasis (diagnosis confirmed by a dermatologist) with MTX (10-20 mg per week) for a minimum of 3 months. Moderate to severe psoriasis is defined here as plaque-type psoriasis affecting a body surface area \> 10%.
•Be 21 years of age or older, but not 60 years of age or older.
•If participant is female of child bearing potential, then subject must indicate that she is not pregnant.
•Must be fully informed of the potential for AMT to adversely affect a fetus, and must agree to use highly effective method of birth control beginning at the time of consent, during the study, and for 3 months after leaving the study.
•Women of childbearing potential may enter the study only after a confirmed menstrual period, and must have a negative urine pregnancy test at the time of screening and within 24 hours of each study drug dose.
•Have adequate hematologic function as evidenced by the following :results obtained from a blood sample drawn within 2 days of day 0:
•* WBC \> 4,500/ mm3
•* Platelet Count \> 150,000/mm3
•* Hemoglobin \> 12.0 gm/dL
+11 more criteria

Exclusion Criteria

•A known history of hepatitis, liver fibrosis or cirrhosis (grades IIIA, IIIB or IV), diabetes (type I or II), HIV infection, tuberculosis, interstitial lung disease, or an abnormal screening chest x-ray that is consistent with interstitial lung disease.
•Known peptic ulcer, ulcerative colitis or Crohn's disease.
•Body mass index (BMI) \<19.0 or \> 35.0 (see appendix C).
•Within 2 weeks prior to randomization use of any of the following medications that may result in drug/drug interactions with aminopterin: methotrexate, trimethoprim with or without sulfamethoxazole; sulfonamides; sulfonylureas; pyrimethamine; triamethamine; dipyridamole; colchicine; probenecid; aminoglycosides; theophylline; phenytoin; and folinic acid (i.e., leucovorin) unless prescribed by the investigator to treat study drug related toxicity.
•Within 2 weeks prior to randomization use of salicylates, non-steroidal anti-inflammatory (NSAID) drugs, including Over-The-Counter nonprescription use of aspirin, ibuprofen or naproxen.
•Use of medications that may be negatively influenced by regular folic acid supplementation such as the anti-epileptics phenobarbital, diphenylhydantoin, and primidone.
•Use of any investigational medication within 30 days prior to admission to the study.
•Inability to abstain from alcohol during the study.
•A history of substance abuse, drug addiction or alcoholism.
•Unwillingness to use an adequate form of contraception during the study and for 3 months after the study.
+5 more criteria

Locations (1)

Baylor Research Institute

Dallas, Texas, United States

Key Dates

Start Date

June 1, 2009

Primary Completion Date

April 1, 2010

Completion Date

April 1, 2010

Last Updated

September 20, 2019

Enrollment

ACTUAL participants

Conditions

Psoriasis

Interventions

Aminopterin

DRUG

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

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Psoriasis

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RECRUITINGPHASE3

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NCT07116967

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RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 20, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Aminopterin Pharmacokinetic Study In Moderate to Severe Psoriasis

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments