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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01844973

Enrollment

Registered

2013-05-03

Start date

2013-04-30

Completion date

2013-08-31

Last updated

2013-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Brief summary

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

Interventions

DRUGM518101

Proper quantity twice a day

DRUGVehicle

Proper quantity twice a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026