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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ASP3291 low dose

Group Type EXPERIMENTAL

ASP3291

Intervention Type DRUG

Oral tablets

ASP3291 high dose

Group Type EXPERIMENTAL

ASP3291

Intervention Type DRUG

Oral tablets

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral tablets

Interventions

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ASP3291

Oral tablets

Intervention Type DRUG

Placebo

Oral tablets

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No