Study to Evaluate the Pharmacokinetics and the Safety of M518101 in Plaque Psoriasis Patients
Completed · Phase 1
Conditions studied: Psoriasis
In brief
This study is to evaluate the pharmacokinetics and safety of M518101 in male and female plaque psoriasis patients.
Key facts
- Study ID
- NCT01844973
- Run by
- Maruho North America Inc.
- People needed
- 30
- Starts
- 2013-04-01
- Expected to finish
- 2013-08-01
- Last updated by the study team
- 2013-08-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Who are able and willing to give signed informed consent
- Who are male or females aged 18 years or older with plaque psoriasis confirmed by the Investigator.
- Who have ≥20% of body surface area (BSA) afflicted with plaques
- Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study.
You may not qualify if…
- Who have a history of allergy to vitamin D3 derivative preparations or a history of relevant drug hypersensitivity.
- BMI > 32.0 kg/m2
- Who are pregnant or lactating.
- Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
- Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
- Who have clinically relevant history or presence of any disease or surgical history other than psoriasis which is likely to affect the conduct of the study.
- Whose serum calcium levels exceed the upper limit of reference range
- Who have used any investigational medicinal product and/or participated in any clinical study within 60 days of randomization.
- Who have taken any durg with known effects on calcium metabolism within 30days of randomization
- Who have been treated with any drug with a known risk of QT prolongation within 30days of randomization.
Where it is running
- Orenge County Research Center — Tustin, California, United States
Full record on ClinicalTrials.gov
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