Bioavailability in Patient With Psoriasis: Metoject Prefilled Pen

NCT ID: NCT02097173

Last Updated: 2015-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31

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).

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Methotrexate

Intervention Type: DRUG

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

Group Type: OTHER

Methotrexate

Intervention Type: DRUG

Interventions

Methotrexate

Intervention Type: DRUG

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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PPD Development, LP

INDUSTRY

Sponsor Role: collaborator

medac GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

Countries

United States

Other Identifiers

MC-MTX.12/PK

Identifier Type: -

Identifier Source: org_study_id