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

Phase 1

Completed

• Conditions: Psoriasis
• Interventions: Drug: M518101; Drug: Vehicle

• Registration Number: NCT01844973
• Lead Sponsor: Maruho North America Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-24
• Study First Submitted QC: 2013-04-29
• Study First Posted: 2013-05-03
• Status Verified: 2013-08
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Last Update Submitted: 2013-08-15
• Last Update Posted: 2013-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
M518101	M518101	-
Vehicle	Vehicle	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Orenge County Research Center; 🇺🇸 Tustin, California, United States