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

NCT01844973 | Completed Phase 1

• 1 other identifier: M518101-US05
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Vehicle

PLACEBO COMPARATOR

Drug: Vehicle

M518101

ACTIVE COMPARATOR

Drug: M518101

Interventions

M518101 DRUG

Proper quantity twice a day

M518101

Vehicle DRUG

Proper quantity twice a day

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maruho North America Inc.: lead

Study Sites (1)

Orenge County Research Center

Tustin, California, 92780, United States

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2013
• First Posted: May 3, 2013
• Study Start: April 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 19, 2013

Record last verified: 2013-08

Locations

US (1)