A Study of a Single Dose of ASP3291 in Subjects With Ulcerative Colitis
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Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subject has a previously documented diagnosis of ulcerative colitis (UC) with endoscopy and histology consistent with diagnosis
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)
Subject has undergone previous resective colonic surgery
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