Last reviewed · How we verify
NCT02097173
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
Phase 1 trial testing Methotrexate in Psoriasis in 35 participants. Completed.
1 October 2013
Quick facts
| Lead sponsor | medac GmbH |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Enrollment | 35 |
| Start date | 1 May 2013 |
| Primary completion | 1 October 2013 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Methotrexate — full drug profile →
Conditions studied
- Psoriasis — all drugs for Psoriasis →
Sponsor
medac GmbH — full company profile →
Who can join
Adults 18 to 65, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02097173
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Methotrexate
Trials testing the same drug.
- NCT07498465 — A Study to Find the Highest Dose of SNDX-5613 (Revumenib) as a Treatment Option After Hematopoietic Stem Cell Transplant · Phase 1 · withdrawn
- NCT07072585 — Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leuk · Phase 2, PHASE3 · not yet recruiting
- NCT07321912 — Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma · Phase 2 · not yet recruiting
- NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
- NCT07477691 — Immune Modulation During Palynziq® Treatment in Adults (IMPALA) · Phase 4 · not yet recruiting
Other recruiting trials for Psoriasis
Currently open trials in the same condition.
- NCT07471048 — A Study to Evaluate the Impact of a Magnolia Officinalis Dietary Supplement on Immune Biomarkers in Subjects With Psoria · NA · recruiting
- NCT07449234 — A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis · recruiting
- NCT07234838 — Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO) · recruiting
- NCT07194200 — Safety and Efficacy of Lactobacillus Plantarum for Psoriasis: A Randomized Double-Blind Placebo-Controlled Trial · Phase 2 · recruiting
- NCT07250997 — PALLAS Laser for Skin Diseases · NA · recruiting
Other medac GmbH trials
Trials by the same sponsor.
- NCT03156790 — PK, PD, Safety and Immunogenicity of Spectrila in Adults With Acute B-cell Lymphoblastic Leukaemia · Phase 2 · terminated
- NCT02333058 — Treosulfan-based Conditioning in Paediatric Patients With Haematological Malignancies · Phase 2 · completed
- NCT00822393 — Clinical Phase III Trial Treosulfan-based Conditioning Versus Reduced-intensity Conditioning (RIC) · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02097173 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by medac GmbH
- Last refreshed: 13 March 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02097173.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing