PsoriasisPhase 1NCT02097173
Bioavailability in Patient With Psoriasis: Metoject Prefilled Pen
A Phase 1 study testing Methotrexate in people with Psoriasis, run by medac GmbH at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Methotrexate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Oct 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
About this study
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
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
- Being tested
- Methotrexate
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startMay 2013
- Primary completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- medac GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097173
- Sponsor's protocol ID
- MC-MTX.12/PK
- Status last verified
- Mar 2015
- First submitted
- 24 Mar 2014
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02097173
- Acronym / sponsor ID
- MC-MTX.12/PK
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- medac GmbHIndustry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- May 2013
- Primary completion
- Oct 2013 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SC MTX followed by IM MTX | Other | Drug: Methotrexate1 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 |
| IM MTX followed by SC MTX | Other | Drug: Methotrexate1 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methotrexate | Drug | IM MTX followed by SC MTX, SC MTX followed by IM MTX |
Primary outcome
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)
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Methotrexate in people with Psoriasis, run by medac GmbH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.