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
1 other identifier
interventional
16
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2010
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 15, 2011
CompletedFirst Posted
Study publicly available on registry
March 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedJuly 24, 2012
July 1, 2012
1 year
March 15, 2011
July 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic assessment through analysis of blood, fecal and urine samples
Up to Day 4
Study Arms (3)
ASP3291 low dose
EXPERIMENTALASP3291 high dose
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
SNBL Clinical Pharmacology Center
Baltimore, Maryland, 21201, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Senior Medical Director
Astellas Pharma Global Development
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2011
First Posted
March 22, 2011
Study Start
August 1, 2010
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
July 24, 2012
Record last verified: 2012-07