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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01320332

Enrollment

Registered

2011-03-22

Start date

2010-08-31

Completion date

2011-08-31

Last updated

2012-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitis, ASP3291

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.

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.

Interventions

DRUGASP3291

Oral tablets

DRUGPlacebo

Oral tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic assessment through analysis of blood, fecal and urine samples	Up to Day 4

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026