Back to resultsStudy to Evaluate the Pharmacokinetics and the Safety of M518101 in Plaque Psoriasis Patients
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
M518101
Vehicle
Sponsored by
About this trial
This is an interventional basic science trial for Psoriasis
Eligibility Criteria
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.
Sites / Locations
- Orenge County Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Vehicle
M518101
Arm Description
Outcomes
Primary Outcome Measures
Area under the plasma concentration versus time curve (AUC) of M5181
Peak Plasma concentration (Cmax) of M5181
Secondary Outcome Measures
Full Information
NCT ID
NCT01844973
First Posted
April 24, 2013
Last Updated
August 15, 2013
Sponsor
Maruho North America Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01844973
Brief Title
Study to Evaluate the Pharmacokinetics and the Safety of M518101 in Plaque Psoriasis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maruho North America Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to evaluate the pharmacokinetics and safety of M518101 in male and female plaque psoriasis patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Title
M518101
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
M518101
Intervention Description
Proper quantity twice a day
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Proper quantity twice a day
Primary Outcome Measure Information:
Title
Area under the plasma concentration versus time curve (AUC) of M5181
Time Frame
0, 1, 2, 4, 6, 9 12h after dosing
Title
Peak Plasma concentration (Cmax) of M5181
Time Frame
0, 1, 2, 4, 6, 9 12h after dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Orenge County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Pharmacokinetics and the Safety of M518101 in Plaque Psoriasis Patients
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