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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
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Advanced Clinical Research Institute
Anaheim, California, United States
SNBL Clinical Pharmacology Center
Baltimore, Maryland, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Start Date
August 1, 2010
Primary Completion Date
August 1, 2011
Completion Date
August 1, 2011
Last Updated
July 24, 2012
16
ACTUAL participants
ASP3291
DRUG
Placebo
DRUG
Lead Sponsor
Telsar Pharma Inc.
NCT07271069
NCT06975722
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07185009