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

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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.
We found this trial at
1
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Tustin, California 92780
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Tustin, CA
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