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Strategic business decision
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A Phase 1b study to determine the effect of oral olorinab on gastrointestinal transit in adult participants with irritable bowel syndrome (IBS).
This is a single-center, randomized, crossover, double-blind, placebo-controlled study designed to evaluate the effects of olorinab on gastric, small-bowel, and colonic transit in IBS participants with predominant constipation (IBS-C) or with predominant diarrhea (IBS-D).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olorinab, Then Placebo | Experimental | Participants will first receive olorinab, followed by a washout period, and they then will receive placebo. |
|
| Placebo, Then Olorinab | Placebo Comparator | Participants will first receive placebo, followed by a washout period, and they then will receive olorinab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olorinab | Drug | Olorinab tablet by mouth, 3 times a day for 4 days with a final dose on Day 5. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Colonic transit geometric center after consumption of radiolabeled meal, based on the delivery of activated charcoal in a methacrylate-coated capsule | up to 24 hours 30 minutes after consumption of radiolabeled meal | |
| Gastric emptying half-life (t½) as determined by scintigraphic imaging of radiolabeled meal | up to 4 hours 10 minutes after consumption of radiolabeled meal |
| Measure | Description | Time Frame |
|---|---|---|
| Colonic transit geometric center after consumption of radiolabeled meal, based on the delivery of activated charcoal in a methacrylate-coated capsule | up to 48 hours 30 minutes after consumption of radiolabeled meal | |
| Ascending colon emptying t½ of radiolabeled activated charcoal particles delivered in a methacrylate-coated capsule |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arena CT.gov Administrator | Arena Pharmaceuticals | 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 |
|---|---|
| C000728614 | olorinab |
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| Placebo | Drug | Olorinab matching placebo tablet by mouth, 3 times a day for 4 days with a final dose on Day 5. |
|
| up to 24 hours 30 minutes after consumption of radiolabeled meal |
| Gastric emptying after radiolabeled meal | at 2 hours ± 10 minutes and 4 hours ± 10 minutes after consumption of radiolabeled meal |
| Number and severity of adverse events | Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results. | Up to approximately 6 weeks |
| D004066 | Digestive System Diseases |