NCT00937027

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2009

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

June 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

September 20, 2019

Status Verified

November 1, 2012

Enrollment Period

10 months

First QC Date

July 8, 2009

Last Update Submit

September 18, 2019

Conditions

Psoriasis

Keywords

AntifolatePsoriasisAntiinflammatory drugAutoimmune diseaseTreatment

Outcome Measures

Primary Outcomes (2)

  • Aminopterin area under the curve

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

  • Adverse events

    14 days

Secondary Outcomes (1)

  • 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

Study Arms (2)

Aminopterin one 1.0 mg tablet

ACTIVE COMPARATOR
Drug: Aminopterin

Aminopterin 1 four 0.25 mg tablets

ACTIVE COMPARATOR
Drug: Aminopterin

Interventions

AminopterinDRUG

oral tablets, 1.0 mg dose, once weekly, two weeks

Aminopterin 1 four 0.25 mg tabletsAminopterin one 1.0 mg tablet

Eligibility Criteria

Age21 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • Have adequate liver function as evidenced by the following results obtained from a blood sample drawn within 2 days of day 0:
  • AST (SGOT) ≤ 40 IU/L
  • ALT (SGPT) ≤ 40 IU/L
  • Alkaline Phosphatase ≤ 120 IU/L
  • Total Bilirubin ≤ 1.2 mg/dL
  • +6 more criteria

You may not qualify if:

  • 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.
  • A female who is pregnant, intends to become pregnant during the study (or within 6 months after study completion), or nursing.
  • Concurrent participation in another clinical trial involving experimental treatment.
  • Current and uncontrolled infection, cardiovascular, pulmonary, hepatic or GI conditions that will interfere with the conduct of the trial or pose an additional morbid risk.
  • Any renal conditions that will interfere with the conduct of the trial or pose an additional morbid risk.
  • Any concurrent disease or condition that in the opinion of the investigator impairs the subject's ability to complete the trial. Psychological, familial, sociological, geographical or medical conditions which, in the Investigator's opinion, could compromise compliance with the objectives and procedures of this protocol or obscure interpretation of the trial's data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor Research Institute

Dallas, Texas, 75246, United States

Location

Related Publications (1)

  • Menter A, Thrash B, Cherian C, Matherly LH, Wang L, Gangjee A, Morgan JR, Maeda DY, Schuler AD, Kahn SJ, Zebala JA. Intestinal transport of aminopterin enantiomers in dogs and humans with psoriasis is stereoselective: evidence for a mechanism involving the proton-coupled folate transporter. J Pharmacol Exp Ther. 2012 Sep;342(3):696-708. doi: 10.1124/jpet.112.195479. Epub 2012 May 31.

    PMID: 22653877DERIVED

MeSH Terms

Conditions

PsoriasisAutoimmune Diseases

Interventions

Aminopterin

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Alan Menter, M.D.

    Baylor Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2009

First Posted

July 10, 2009

Study Start

June 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

September 20, 2019

Record last verified: 2012-11

Locations

US(1)