Study to Evaluate the Pharmacokinetics and the Safety of M518101 in Plaque Psoriasis Patients
Status: | Recruiting |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/30/-0001 |
Start Date: | April 2013 |
Contact: | Maruho North America |
Email: | mnaictinfo@mii.maruho.co.jp |
This study is to evaluate the pharmacokinetics and safety of M518101 in male and female
plaque psoriasis patients.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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