Status:
COMPLETED
Study to Evaluate the Pharmacokinetics and the Safety of M518101 in Plaque Psoriasis Patients
Lead Sponsor:
Maruho North America Inc.
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is to evaluate the pharmacokinetics and safety of M518101 in male and female plaque psoriasis patients.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01844973
Start Date
April 1 2013
End Date
August 1 2013
Last Update
August 19 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Orenge County Research Center
Tustin, California, United States, 92780