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OpenTrials
Completed

NCT Number: NCT01844973

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Orenge County Research Center

Tustin, California, 92780, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

M518101

Drug

Proper quantity twice a day

Vehicle

Drug

Proper quantity twice a day

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Maruho North America Inc.

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 3, 2013
Registry last updated
Aug 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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