NCT01844973CompletedPhase 1
Study to Evaluate the Pharmacokinetics and the Safety of M518101 in Plaque Psoriasis Patients
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Maruho North America Inc.
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Peak Plasma concentration (Cmax) of M5181
Study Overview
Brief Summary
This study is to evaluate the pharmacokinetics and safety of M518101 in male and female plaque psoriasis patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Vehicle
Placebo Comparator
Intervention: Vehicle (Drug)
M518101
Active Comparator
Intervention: M518101 (Drug)
Outcomes
Primary Outcomes
Peak Plasma concentration (Cmax) of M5181
Time Frame: 0, 1, 2, 4, 6, 9 12h after dosing
Area under the plasma concentration versus time curve (AUC) of M5181
Time Frame: 0, 1, 2, 4, 6, 9 12h after dosing
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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