A Study of a Single Dose of ASP3291 in Subjects With Ulcerative Colitis
NCT ID: NCT01320332
Last Updated: 2012-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2010-08-31
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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ASP3291 low dose
ASP3291
Oral tablets
ASP3291 high dose
ASP3291
Oral tablets
Placebo
Placebo
Oral tablets
Interventions
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ASP3291
Oral tablets
Placebo
Oral tablets
Eligibility Criteria
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Inclusion Criteria
* If female, the subject is at least 2 years postmenopausal or is surgically sterile per documentation provided by a third party medical professional or the subject agrees to use 2 highly effective methods of birth control during the study and is not pregnant or lactating
* Subject is willing and able to comply with the study requirements
* Subject has a body mass index (BMI) of \<32 kg/m2
* Subject has ulcerative colitis requiring treatment with 5-aminosalicylic acid (5-ASA)
Exclusion Criteria
* Subject has previously diagnosed Crohn's Disease based on medical history
* Subject has an extension of disease limited to ulcerative proctitis
* Subject has active peptic ulcer disease based on medical history
* Subject is currently being treated with any prescription medication except the following: A stable dose of 5-aminosalicylic acid (5-ASA) for at least 2 weeks, oral contraceptives or hormone replacement therapy (HRT)
* Subject has a history of human immunodeficiency virus (HIV)
* Subject has a history of severe allergic or anaphylactic reactions
* Subject has a history of drug or alcohol abuse
18 Years
65 Years
ALL
No
Sponsors
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Telsar Pharma Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Senior Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Locations
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Advanced Clinical Research Institute
Anaheim, California, United States
SNBL Clinical Pharmacology Center
Baltimore, Maryland, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Countries
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Other Identifiers
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3291-CL-0003
Identifier Type: -
Identifier Source: org_study_id