Psoriasis
Conditions
Brief 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).
Interventions
DRUGMethotrexate
Sponsors
PPD Development, LP
medac GmbH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | 8 days |
Countries
United States
Outcome results
None listed