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

Phase 1

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: ASP3291; Drug: Placebo

• Registration Number: NCT01320332
• Lead Sponsor: Telsar Pharma Inc.

Brief 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.

Detailed Description

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 Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-03-15
• Study First Submitted QC: 2011-03-21
• Study First Posted: 2011-03-22
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-23
• Last Update Posted: 2012-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASP3291 low dose	ASP3291	-
Placebo	Placebo	-
ASP3291 high dose	ASP3291	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic assessment through analysis of blood, fecal and urine samples	Up to Day 4

Trial Locations

Locations (3)

Advanced Clinical Research Institute; 🇺🇸 Anaheim, California, United States

Clinical Trials of Texas, Inc.; 🇺🇸 San Antonio, Texas, United States

SNBL Clinical Pharmacology Center; 🇺🇸 Baltimore, Maryland, United States