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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01320332
Recruitment Status : Completed
First Posted : March 22, 2011
Last Update Posted : July 24, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: ASP3291 Drug: Placebo Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ASP3291 low dose Drug: ASP3291
Oral tablets

Experimental: ASP3291 high dose Drug: ASP3291
Oral tablets

Placebo Comparator: Placebo Drug: Placebo
Oral tablets

Primary Outcome Measures :
  1. Pharmacokinetic assessment through analysis of blood, fecal and urine samples [ Time Frame: Up to Day 4 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01320332

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.
Study Director: Senior Medical Director Astellas Pharma Global Development

Responsible Party: Telsar Pharma Inc. Identifier: NCT01320332     History of Changes
Other Study ID Numbers: 3291-CL-0003
First Posted: March 22, 2011    Key Record Dates
Last Update Posted: July 24, 2012
Last Verified: July 2012

Keywords provided by Telsar Pharma Inc.:
Ulcerative colitis

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