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CompletedNCT02097173Updated Mar 17, 2015

Bioavailability in Patient With Psoriasis: Metoject Prefilled Pen

A Phase 1 interventional study of Methotrexate in Psoriasis, sponsored by medac GmbH. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-03-17.

Sponsored by medac GmbH · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This study is conducted to assess the relative bioavailability of MTX administered subcutaneously via a prefilled pen (50mg/mL) compared with MTX administered via IM injection (25mg/mL).

02

Conditions studied

  • Psoriasis

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03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 35 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

medac GmbH is the lead sponsor of 21 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Is able to understand and follow instructions during the study
  • Has a diagnosis of moderate to severe psoriasis based on a dermatologic evaluation
  • Provides written informed consent
  • Is male or female and is aged 18 to 65 years, inclusive
  • Has a body mass index (BMI) within the range 18 through 30 kg/m2.

Main Exclusion Criteria:

  • Is receiving concomitant treatment for psoriasis with a biologic or conventional systemic treatments (eg, cyclosporine, azathioprine, fumaric acid esters, Leflunomide), other than MTX every week
  • Has used antibiotics within 14 days prior to Screening or requires use prior to study completion
  • Has used any of the following medications within 14 days prior to Screening or requires use prior to study completion, unless on a stable, daily dose: Non steroidal antiinflammatory drugs (NSAIDs), Diuretics, Folic Acid, Hydrochloroquine, Probenicid, Proton-pump inhibitors
  • Has, other than psoriasis, any uncontrolled cardiac disease, liver disease, lung disease, hematologic disease, gastrointestinal disease, or other systemic disease, that in the opinion of the investigator, would present an unacceptable risk if he or she were to participate in the study
  • Has ongoing acute or chronic infection within 14 days prior to Screening
  • Has renal insufficiency , hepatic insufficiency, impaired hematopoiesis, known severe, acute, or chronic infection, history of malignancy, history of or suspected abuse of drugs or alcohol
  • allergic reactions or serious adverse reactions to the study drug
  • Is a female subject who is pregnant, trying to become pregnant, or breast feeding, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control
  • Is a male subject with a female partner of childbearing potential, not had a vasectomy and not using a condom and/or cervical cap/diaphragm with spermicide
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Other
    SC MTX followed by IM MTX

    1 subcutaneous injection of 30 mg methotrexate administered by a prefilled pen (50mg/mL) followed by 1 intramuscular injection of 30 mg methotrexate (comparator) after a wash-out phase of 1 week

    Drug: Methotrexate

  • Other
    IM MTX followed by SC MTX

    1 intramuscular injection of 30 mg methotrexate (comparator) followed by 1 subcutaneous injection of 30 mg methotrexate by a prefilled pen (50mg/mL) after a wash-out phase of 1 week

    Drug: Methotrexate

Interventions

  • DrugMethotrexate
06

What researchers measure

Primary outcomes

  1. To determine the relative bioavailability of MTX based on the parent compound MTX when administered by SC injection with a prefilled pen (50 mg/mL) as compared with IM administration (25 mg/mL)

    Time frame: 8 days

07

Study locations

1 site
  • Clinical Trials of Texas, Inc.
    San Antonio, Texas 78229, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02097173
Lead sponsor
medac GmbH
Collaborators
PPD DEVELOPMENT, LP
Responsible party
Sponsor
First posted
Mar 26, 2014
Start date
May 2013
Primary completion
Oct 2013
Last update
Mar 17, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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