Effect of Olorinab on Gastrointestinal Transit in Patients With Irritable Bowel Syndrome

Phase 1

Terminated

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: Olorinab; Drug: Placebo

• Registration Number: NCT04655599
• Lead Sponsor: Arena Pharmaceuticals

Brief Summary

A Phase 1b study to determine the effect of oral olorinab on gastrointestinal transit in adult participants with irritable bowel syndrome (IBS).

Detailed Description

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 Timeline

• Study First Submitted: 2020-11-19
• Study First Submitted QC: 2020-12-04
• Study First Posted: 2020-12-07
• Study Start: 2021-01-29
• Primary Completion: 2021-04-13
• Study Completion: 2021-04-13
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-13
• Last Update Posted: 2021-05-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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 the duration of the study that may confound efficacy assessments in the clinical judgment of the Investigator (or designee)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo, Then Olorinab	Olorinab	Participants will first receive placebo, followed by a washout period, and they then will receive olorinab.
Olorinab, Then Placebo	Placebo	Participants will first receive olorinab, followed by a washout period, and they then will receive placebo.
Placebo, Then Olorinab	Placebo	Participants will first receive placebo, followed by a washout period, and they then will receive olorinab.
Olorinab, Then Placebo	Olorinab	Participants will first receive olorinab, followed by a washout period, and they then will receive placebo.

Primary Outcome Measures

Name	Time	Method
Gastric emptying half-life (t½) as determined by scintigraphic imaging of radiolabeled meal	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	up to 24 hours 30 minutes after consumption of radiolabeled meal

Secondary Outcome Measures

Name	Time	Method
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	Up to approximately 6 weeks	Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
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	up to 24 hours 30 minutes after consumption of radiolabeled meal

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States