Irritable Bowel Syndrome
Conditions
Keywords
Diarrhea-predominant irritable bowel syndrome
Brief summary
The primary purpose of this study is to evaluate the effects of BMS-562086 on small bowel and colonic transits in female subjects with diarrhea-predominant irritable bowel syndrome (D-IBS)
Interventions
DRUGPlacebo
Tablets, Oral, once daily, 2 weeks
DRUGBMS-562086
Tablets, Oral, once daily, 2 weeks
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Female subjects with D-IBS symptoms based on Rome II criteria and the subject's responses to the Bowel Disease Questionnaire
Exclusion criteria
* Clinically significant prolonged diarrhea with dehydration requiring IV fluid within 60 days prior to baseline visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radioscintigraphy will be used to determine the effects of BMS-562086 on gastrointestinal transit | taken at baseline on nominal study days 3,4, and 5 and post dose on nominal study days 14,15, 16 |
Secondary
| Measure | Time frame |
|---|---|
| Daily diary will be used to record the effects of BMS-562086 on bowel patterns and visceral symptoms. | throughout the study |
| Safety | Safety labs at screening, nominal study days -3, 8, 15, 42, and 70 (discharge). ECGs will be taken at screening, nominal days 5 or 6, 14, and discharge. Vital signs will be taken at screening, on nominal days 3, 4, 5, 7, 8, 10, 11, 42 and discharge |
| Blood pharmacokinetics | PK samples will be taken on nominal days 8, 14 (serial: predose 0.5, 1, 2, 4, 6, 9 hours post dose), 15 (pre dose and 9 hours post dose), 16, 42 and discharge |
Countries
United States
Outcome results
None listed