Bioavailability in Patient With Psoriasis: Metoject Prefilled Pen

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02097173
• Other study ID #: MC-MTX.12/PK
• Status: Completed
• Phase: Phase 1
• First received: March 24, 2014
• Last updated: March 13, 2015
• Start date: May 2013

Study information

• Verified date: March 2015
• Source: medac GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Methotrexate

Locations

Country	Name	City	State
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
medac GmbH	PPD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No