A Study of a Single Dose of ASP3291 in Subjects With Ulcerative Colitis

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the pharmacokinetics (PK) and to assess safety and tolerability of a single dose of ASP3291 in subjects with ulcerative colitis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Telsar Pharma Inc.

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

• Subject has a history of drug or alcohol abuse