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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | 0 mg |
|
| 2 | Other | 25 mg |
|
| 3 | Other | 100 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Tablets, Oral, once daily, 2 weeks |
| |
| BMS-562086 |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C542342 | pexacerfont |
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| Drug |
Tablets, Oral, once daily, 2 weeks |
|
| 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 |
| D004066 | Digestive System Diseases |