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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Telsar Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01320332
First received: March 15, 2011
Last updated: July 23, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Ulcerative Colitis
 Drug: ASP3291
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Telsar Pharma Inc.:

Primary Outcome Measures:
  • Pharmacokinetic assessment through analysis of blood, fecal and urine samples [ Time Frame: Up to Day 4 ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: August 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP3291 low dose Drug: ASP3291
Oral tablets
Experimental: ASP3291 high dose Drug: ASP3291
Oral tablets
Placebo Comparator: Placebo Drug: Placebo
Oral tablets

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01320332

Locations
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
United States, Maryland
SNBL Clinical Pharmacology Center
Baltimore, Maryland, United States, 21201
United States, Texas
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Telsar Pharma Inc.
Investigators
Study Director: Senior Medical Director Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Telsar Pharma Inc.
ClinicalTrials.gov Identifier: NCT01320332     History of Changes
Other Study ID Numbers: 3291-CL-0003
Study First Received: March 15, 2011
Last Updated: July 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Telsar Pharma Inc.:
Ulcerative colitis
ASP3291

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013