Bioavailability in Patient With Psoriasis: Metoject Prefilled Pen

Relative Bioavailability of Methotrexate (MTX) 50 mg/mL Administered Subcutaneously (SC) by a Disposable Autoinjector (Metoject® Prefilled Pen) Compared With Intramuscular (IM) Administration of the United States Reference Listed Drug Methotrexate Injection (USP 25 mg/mL [Hospira]) in Patients With Psoriasis

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).

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Methotrexate

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: medac GmbH
• Collaborators: PPD

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: March 24, 2014
• First Submitted That Met QC Criteria: March 25, 2014
• First Posted (Estimate): March 26, 2014

Study Record Updates

• Last Update Posted (Estimate): March 17, 2015
• Last Update Submitted That Met QC Criteria: March 13, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Methotrexate
• Other Study ID Numbers: MC-MTX.12/PK