Clinical Trials Logo
  1. Home
  2. Inflammatory Bowel Disease
  3. NCT01221818

A Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study of E6007 in Healthy Subjects

Inflammatory Bowel Disease Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study of E6007 in Healthy Subjects

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of single oral ascending doses of E6007 in healthy subjects.

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled, ascending single dose study to evaluate the safety and tolerability of E6007 in healthy subjects. Six dose groups will be evaluated. Subjects will receive either 25 mg, 50 mg, 100 mg, 200 mg, 400 mg, or 600 mg E6007 or matching placebo tablets. Subjects will undergo screening evaluations, baseline evaluations, Day 1 (dosing day), and Days 2-5 evaluations. They will also have a follow-up visit on Day 90 and a Day 180 follow-up phone call. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01221818
Study type Interventional
Source Eisai Inc.
Contact
Status Completed
Phase Phase 1
Start date September 2010
View Details
See also
  Status Clinical Trial Phase
Withdrawn NCT03278912 - Natural History of Intestinal Inflammation in People With Primary Immune Dysregulations
Terminated NCT00061282 - Clotrimazole Enemas for Pouchitis in Children and Adults Phase 1/Phase 2
Recruiting NCT05579392 - A Randomized Crossover Trial of Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis N/A
Completed NCT03264690 - Study to Observe the Change in Microbiome in Human Derived Sample and the Relation With Clinical Response Before and After the Anti-TNF Treatment in IBD Patients
Recruiting NCT02861053 - Inflammatory Bowel Disease : Could a Regular Physical Activity Reduce Patients Fatigue ? N/A
Recruiting NCT02275676 - Resting Energy Expenditure and Nutritional Status in IBD N/A
Completed NCT02161640 - Vascular Dysfunction in Paediatric IBD N/A
Completed NCT02503696 - Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD) N/A
Completed NCT02197780 - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD N/A
Completed NCT01933867 - Water-aided Colonoscopy in Inflammatory Bowel Disease Patients N/A
Completed NCT01852760 - Assessment of Disease Activity in Ulcerative Colitis by Endoscopic Ultrasound N/A
Completed NCT01860651 - Web-based Monitoring in Children and Adolescents With Inflammatory Bowel Disease N/A
Completed NCT01676324 - FOCUS: The Future of Fecal Calprotectin Utility Study for the Diagnosis and Management of Inflammatory Bowel Disease (IBD) N/A
Completed NCT01692743 - Telemedicine in Patients With Inflammatory Bowel Disease (TELE-IBD) Phase 3
Completed NCT01688557 - Trial on Innovative Technologies in Colonoscopy N/A
Completed NCT01666535 - Infliximab IBD Influenza Vaccine Study N/A
Completed NCT01557387 - Real-time Diagnosis of Pseudopolyps During Colonoscopy
Completed NCT01981616 - Immune Response to Systemic and Mucosal Antigenic Challenge in the Presence of Vedolizumab Phase 1
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Completed NCT02322008 - Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical Practice N/A