Trial | NCT01320332  Report issue

Title

A Study of a Single Dose of ASP3291 in Subjects With Ulcerative Colitis
A Phase 1, Randomized, Double-Blind, Placebo Controlled Study to Assess the Pharmacokinetics, Safety, and Tolerability of ASP3291 Following a Single Oral Dose in Subjects With Ulcerative Colitis

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    asp3291 ...

  • Study Participants

    16
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.
After an 11-day screening period, subjects check into a clinic, are dosed on Day 1 and stay in the clinic for 4 days to monitor pharmacokinetic and safety parameters.
Study Started
Aug 31
2010
Primary Completion
Aug 31
2011
Study Completion
Aug 31
2011
Last Update
Jul 24
2012
Estimate

Drug ASP3291

Oral tablets

Drug Placebo

Oral tablets

ASP3291 low dose Experimental

ASP3291 high dose Experimental

Placebo Placebo Comparator

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
No Results Posted