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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01320332
• Date of registration: 15/03/2011
• Prospective Registration: No
• Primary sponsor: Telsar Pharma Inc.
• Public title: A Study of a Single Dose of ASP3291 in Subjects With Ulcerative Colitis
• Scientific 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
• Date of first enrolment: August 2010
• Target sample size: 16
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01320332
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Senior Medical Director
• Affiliation: Astellas Pharma Global Development

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: ASP3291

Drug: Placebo

Primary Outcome(s)

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

Secondary ID(s)

3291-CL-0003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors