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

Psoriasis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01844973
• Other study ID #: M518101-US05
• Status: Completed
• Phase: Phase 1
• First received: April 24, 2013
• Last updated: August 15, 2013
• Start date: April 2013
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Maruho North America Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• M518101
Proper quantity twice a day
• Vehicle
Proper quantity twice a day

Locations

Country	Name	City	State
United States	Orenge County Research Center	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
Maruho North America Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration versus time curve (AUC) of M5181		0, 1, 2, 4, 6, 9 12h after dosing	Yes
Primary	Peak Plasma concentration (Cmax) of M5181		0, 1, 2, 4, 6, 9 12h after dosing	Yes