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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
1
Mayo Clinic
Rochester, Minnesota, United States
Colonic transit geometric center after consumption of radiolabeled meal, based on the delivery of activated charcoal in a methacrylate-coated capsule
Time frame: up to 24 hours 30 minutes after consumption of radiolabeled meal
Gastric emptying half-life (t½) as determined by scintigraphic imaging of radiolabeled meal
Time frame: up to 4 hours 10 minutes after consumption of radiolabeled meal
Colonic transit geometric center after consumption of radiolabeled meal, based on the delivery of activated charcoal in a methacrylate-coated capsule
Time frame: 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
Time frame: up to 24 hours 30 minutes after consumption of radiolabeled meal
Gastric emptying after radiolabeled meal
Time frame: 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.
Time frame: Up to approximately 6 weeks
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