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

Completed · Phase 1 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT01320332

Run by

Telsar Pharma Inc.

People needed

16

Starts

2010-08-01

Expected to finish

2011-08-01

Last updated by the study team

2012-07-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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