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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01320332
• Other study ID #: 3291-CL-0003
• Status: Completed
• Phase: Phase 1
• First received: March 15, 2011
• Last updated: July 23, 2012
• Start date: August 2010
• Est. completion date: August 2011

Study information

• Verified date: July 2012
• Source: Telsar Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• ASP3291
Oral tablets
• Placebo
Oral tablets

Locations

Country	Name	City	State
United States	Advanced Clinical Research Institute	Anaheim	California
United States	SNBL Clinical Pharmacology Center	Baltimore	Maryland
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Telsar Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic assessment through analysis of blood, fecal and urine samples		Up to Day 4	No