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

Syntrix Biosystems, Inc.1 site in 1 country22 target enrollmentJune 2009

ConditionsPsoriasis

InterventionsAminopterin

DrugsAminopterin

Overview

Phase: Phase 1
Intervention: Aminopterin
Conditions: Psoriasis
Sponsor: Syntrix Biosystems, Inc.
Enrollment: 22
Locations: 1
Primary Endpoint: Aminopterin area under the curve
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

April 2010

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Syntrix Biosystems, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

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.

Arms & Interventions

Aminopterin one 1.0 mg tablet

Intervention: Aminopterin

Aminopterin 1 four 0.25 mg tablets

Intervention: Aminopterin

Outcomes

Primary Outcomes

Aminopterin area under the curve

Time Frame: 0.0, 0.5, 1.0, 1.5, 2.0, 3.0, 5.0, 7.0, 10.0 and 12.0 hours

Adverse events

Time Frame: 14 days

Secondary Outcomes

Aminopterin concentration maximum, time to maximal aminopterin concentration, aminopterin volume of distribution and aminopterin half-life.(0.0, 0.5, 1.0, 1.5, 2.0, 3.0, 5.0, 7.0, 10.0 and 12.0 hours)