PsoriasisPhase 1NCT00937027
Aminopterin Pharmacokinetic Study In Moderate to Severe Psoriasis
A Phase 1 study testing Aminopterin in people with Psoriasis, run by Syntrix Biosystems, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 59 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Aminopterin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Apr 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 21Show fewer
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Psoriasis
- Being tested
- Aminopterin
- Keywords
- Antifolate, Psoriasis, Antiinflammatory drug, Autoimmune disease, Treatment
- Medical subject headings
- Psoriasis, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AminopterinDrug
oral tablets, 1.0 mg dose, once weekly, two weeks
| Study group | Role | What they receive |
|---|---|---|
| Aminopterin one 1.0 mg tablet | Active comparator | Not described Receives: Drug: Aminopterin |
| Aminopterin 1 four 0.25 mg tablets | Active comparator | Not described Receives: Drug: Aminopterin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aminopterin area under the curve
Measured: 0.0, 0.5, 1.0, 1.5, 2.0, 3.0, 5.0, 7.0, 10.0 and 12.0 hours
Adverse events
Measured: 14 days
Secondary outcomes (1)
Aminopterin concentration maximum, time to maximal aminopterin concentration, aminopterin volume of distribution and aminopterin half-life.
Measured: 0.0, 0.5, 1.0, 1.5, 2.0, 3.0, 5.0, 7.0, 10.0 and 12.0 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syntrix Biosystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan Menter, M.D., Principal investigator, Baylor Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937027
- Sponsor's protocol ID
- Syntrix-AMT-PSO-101
- Other IDs
- NIH Grant #: R43AI068282
- Status last verified
- Nov 2012
- First submitted
- 8 Jul 2009
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22653877
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00937027
- Acronym / sponsor ID
- Syntrix-AMT-PSO-101
- Conditions
- Psoriasis
- Keywords
- Antifolate, Psoriasis, Antiinflammatory drug, Autoimmune disease, Treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Syntrix Biosystems, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jun 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 10 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aminopterin one 1.0 mg tablet | Active comparator | Drug: Aminopterin |
| Aminopterin 1 four 0.25 mg tablets | Active comparator | Drug: Aminopterin |
Who may qualify
- Ages
- 21 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aminopterinoral tablets, 1.0 mg dose, once weekly, two weeks | Drug | Aminopterin 1 four 0.25 mg tablets, Aminopterin one 1.0 mg tablet |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Derived from this study: PubMed 22653877Menter 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.
Related trials for Psoriasis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Menter, M.D. principal investigator
Baylor Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aminopterin in people with Psoriasis, run by Syntrix Biosystems, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00937027, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.