Safety/Tolerability and Pharmacokinetics of RQ-00310941-00 (117507)
Research type
Research Study
Full title
A Phase 1, Multi-Part Study Designed to Assess the Safety and Pharmacokinetics of RQ-00310941-00 after Single and Multiple Ascending Oral Doses in Healthy Subjects, and to Evaluate the Safety, Pharmacokinetics and Effect on Symptom Relief in Ulcerative Colitis Patients with Low Grade (Mild) Active Disease
IRAS ID
172910
Contact name
Toshinori Yamamoto
Contact email
Sponsor organisation
RaQualia Pharma Inc.
Eudract number
2015-000285-55
Duration of Study in the UK
0 years, 10 months, 16 days
Research summary
The Sponsor is developing the study drug, RQ-00310941-00, for the potential symptomatic relief of visceral pain and diarrhoea in lower gastrointestinal (GI) disorders such as diarrhoea-predominant Irritable Bowel Syndrome (IBS-D) and Inflammatory Bowel Disease (Crohn’s disease and Ulcerative Collitis). \n\nThe study will assess the safety of the study drug, and how the body affects the study drug. \n\nThe study will consist of parts 1 A, B and C, Part 2 and Part 3. \n\nPart 1A will be a Single Ascending Dose (SAD) evaluation consisting of Regimens A-F. \nPart 1B will be a food effect evaluation consisting of Regimens G and H. \nPart 1C will be a gender effect evaluation and will consist of Regimen I.\n\nPart 2 will be a Multiple Ascending Dose (MAD) evaluation of the study drug consisting of Regimens J-L.\n\nPart 3 will be a multiple dose evaluation in Ulcerative Collitis patients of at least 4 months. Consisting of Regimen M.\n\nThe study will involve up to 88 healthy male (parts 1a and 2) and female (Part 1C and 3) subjects and 25 Ucerative Collitis patients (Part 3).\n
REC name
Wales REC 2
REC reference
15/WA/0163
Date of REC Opinion
23 Jun 2015
REC opinion
Further Information Favourable Opinion