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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: ASP3291
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASP3291 low dose<br> | Drug: ASP3291<br>* Oral tablets<br>|
| Experimental: ASP3291 high dose<br> | Drug: ASP3291<br>* Oral tablets<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic assessment through analysis of blood, fecal and urine samples |  | Up to Day 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative colitis, ASP3291