Effect of Olorinab on Gastrointestinal Transit in Patients With Irritable Bowel Syndrome (NCT04655599) | Clinical Trial Compass
TerminatedPhase 1
Effect of Olorinab on Gastrointestinal Transit in Patients With Irritable Bowel Syndrome
Stopped: Strategic business decision
United States1 participantsStarted 2021-01-29
Plain-language summary
A Phase 1b study to determine the effect of oral olorinab on gastrointestinal transit in adult participants with irritable bowel syndrome (IBS).
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of irritable bowel syndrome (IBS) with predominant constipation (IBS-C) or IBS with predominant diarrhea (IBS-D) according to Rome IV criteria at Screening
* Body mass index (BMI) 18.0 to 40.0 kilograms per square meter (kg/m\^2), inclusive at Screening
* Negative test results for alcohol and selected drugs at Screening and Day 1
* Negative hepatitis panel (including hepatitis B surface antigen \[HBsAg\] and hepatitis C virus antibody \[anti-HCV\]) and negative for human immunodeficiency virus (HIV) antibody screens at Screening
* Participants with recent (within 6 months of Screening) or ongoing alarm features (unexplained weight loss, nocturnal symptoms, blood mixed with stool) are to have had a diagnostic colonoscopy prior to Screening and after the onset of alarm features (for participants with alarm features) to exclude non-IBS conditions per the Rome IV diagnostic algorithm for IBS
Exclusion Criteria:
* Pregnant or lactating
* Structural or metabolic diseases/conditions that affect the gastrointestinal system
* Diagnosis of IBS with mixed bowel habits (IBS-M) or unsubtyped IBS (IBS-U)
* Unable to withdraw medications that alter gastrointestinal (GI) transit for 72 hours prior to baseline colonic transit assay through the duration of treatment period, with the exception of rescue medicine usage (bisacodyl and loperamide)
* Clinically relevant changes in dietary, lifestyle, or exercise regimen within 30 days prior to Screening and for th…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Colonic transit geometric center after consumption of radiolabeled meal, based on the delivery of activated charcoal in a methacrylate-coated capsule
Timeframe: up to 24 hours 30 minutes after consumption of radiolabeled meal
2
Gastric emptying half-life (t½) as determined by scintigraphic imaging of radiolabeled meal
Timeframe: up to 4 hours 10 minutes after consumption of radiolabeled meal