Bioavailability in Patient With Psoriasis: Metoject Prefilled Pen

NCT02097173 | Completed Phase 1

• 1 other identifier: MC-MTX.12/PK
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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)

  8 days

Study Arms (2)

SC MTX followed by IM MTX

OTHER

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

IM MTX followed by SC MTX

OTHER

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

Methotrexate DRUG

IM MTX followed by SC MTX; SC MTX followed by IM MTX

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• medac GmbH: lead
• PPD Development, LP: collaborator

Study Sites (1)

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: March 26, 2014
• Study Start: May 1, 2013
• Primary Completion: October 1, 2013
• Last Updated: March 17, 2015

Record last verified: 2015-03

Locations

US (1)