Bioavailability in Patient With Psoriasis: Metoject Prefilled Pen

Medac

Status and phase: Completed; Phase 1

Conditions: Psoriasis

Treatments: Drug: Methotrexate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02097173

MC-MTX.12/PK

Details and patient eligibility

About

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).

Enrollment: 35 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

35 participants in 2 patient groups

SC MTX followed by IM MTX

Other group

Description:

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

Treatment:

Drug: Methotrexate

IM MTX followed by SC MTX

Other group

Description:

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

Treatment:

Drug: Methotrexate