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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02148185 |
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Date of registration:
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20/05/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety Study of MT-1303 in Subjects With Crohn's Disease
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Scientific title:
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A Phase I, Open-label Study to Evaluate PK, PD, and Safety of a Single Oral Dose of MT-1303 in Subjects With Moderate to Severe Crohn's Disease |
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Date of first enrolment:
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May 2014 |
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Target sample size:
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1 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02148185 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Japan
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Contacts
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Name:
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Kazuoki Kondo, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mitsubishi Tanabe Pharma Corporation |
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Name:
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Mamoru Watanabe, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Tokyo Medical and Dental University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects who were diagnosed as Crohn's disease
- Subjects who were confirmed as ileal or ileo-colonic type by image inspection.
- Disease severity determined as either "moderate" or "severe"
Exclusion Criteria:
- Present or past history of gastrointestinal surgery which may have impact on drug
absorption
- Subjects with stenosis or fistula in small intestine or colon
Age minimum:
20 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Drug: MT-1303
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Primary Outcome(s)
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Plasma concentration of MT-1303 metabolite
[Time Frame: 15 time points up to 29 days]
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Plasma concentration of MT-1303
[Time Frame: 15 time points up to 29 days]
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Secondary Outcome(s)
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Change from baseline in lymphocyte count after MT-1303 administration
[Time Frame: 16 time points up to 29 days]
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Type of adverse events
[Time Frame: 29 days]
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Secondary ID(s)
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MT-1303-J02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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