- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00937027
Aminopterin Pharmacokinetic Study In Moderate to Severe Psoriasis
September 18, 2019 updated by: Syntrix Biosystems, Inc.
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Dallas, Texas, United States, 75246
- Baylor Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 59 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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
Have adequate renal function as evidenced by the following result obtained from a blood sample drawn within 2 days of day 0:
- GFR estimated by Cockcroft-Gault formula:
- > 90 ml/min (male)
- > 90 ml/min (female)
- Have no detectable urine glucose, urine ketones, or urine protein from a sample obtained within 2 days of day 0.
- Weight of 35 to 90 kg.
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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Aminopterin one 1.0 mg tablet
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oral tablets, 1.0 mg dose, once weekly, two weeks
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Active Comparator: Aminopterin 1 four 0.25 mg tablets
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oral tablets, 1.0 mg dose, once weekly, two weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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0.0, 0.5, 1.0, 1.5, 2.0, 3.0, 5.0, 7.0, 10.0 and 12.0 hours
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Adverse events
Time Frame: 14 days
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14 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Aminopterin concentration maximum, time to maximal aminopterin concentration, aminopterin volume of distribution and aminopterin half-life.
Time Frame: 0.0, 0.5, 1.0, 1.5, 2.0, 3.0, 5.0, 7.0, 10.0 and 12.0 hours
|
0.0, 0.5, 1.0, 1.5, 2.0, 3.0, 5.0, 7.0, 10.0 and 12.0 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alan Menter, M.D., Baylor Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
July 8, 2009
First Submitted That Met QC Criteria
July 9, 2009
First Posted (Estimate)
July 10, 2009
Study Record Updates
Last Update Posted (Actual)
September 20, 2019
Last Update Submitted That Met QC Criteria
September 18, 2019
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Syntrix-AMT-PSO-101
- NIH Grant #: R43AI068282
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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