ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 7 for:    M518101 | psoriasis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01844973
Recruitment Status : Completed
First Posted : May 3, 2013
Last Update Posted : August 19, 2013
Sponsor:
Information provided by (Responsible Party):
Maruho North America Inc.

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

Condition or disease Intervention/treatment Phase
Psoriasis Drug: M518101 Drug: Vehicle Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Study Start Date : April 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Placebo Comparator: Vehicle Drug: Vehicle
Proper quantity twice a day

Active Comparator: M518101 Drug: M518101
Proper quantity twice a day




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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01844973


Locations
United States, California
Orenge County Research Center
Tustin, California, United States, 92780
Sponsors and Collaborators
Maruho North America Inc.

Responsible Party: Maruho North America Inc.
ClinicalTrials.gov Identifier: NCT01844973     History of Changes
Other Study ID Numbers: M518101-US05
First Posted: May 3, 2013    Key Record Dates
Last Update Posted: August 19, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases