Study to Evaluate the Pharmacokinetics and the Safety of M518101 in Plaque Psoriasis Patients

This study is to evaluate the pharmacokinetics and safety of M518101 in male and female plaque psoriasis patients.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: M518101; Drug: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Tustin, California, United States, 92780
      • Orenge County Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Vehicle	Drug: Vehicle; Proper quantity twice a day
ACTIVE_COMPARATOR: M518101	Drug: M518101; Proper quantity twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma concentration versus time curve (AUC) of M5181	0, 1, 2, 4, 6, 9 12h after dosing
Peak Plasma concentration (Cmax) of M5181	0, 1, 2, 4, 6, 9 12h after dosing

Collaborators and Investigators

• Sponsor: Maruho North America Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): August 1, 2013

Study Registration Dates

• First Submitted: April 24, 2013
• First Submitted That Met QC Criteria: April 29, 2013
• First Posted (ESTIMATE): May 3, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): August 19, 2013
• Last Update Submitted That Met QC Criteria: August 15, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: M518101-US05