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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04655599
• Other study ID #: APD371-106
• Status: Terminated
• Phase: Phase 1
• Start date: January 29, 2021
• Est. completion date: April 13, 2021

Study information

• Verified date: May 2021
• Source: Arena Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 13, 2021
• Est. primary completion date: April 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Olorinab
Olorinab tablet by mouth, 3 times a day for 4 days with a final dose on Day 5.
• Placebo
Olorinab matching placebo tablet by mouth, 3 times a day for 4 days with a final dose on Day 5.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Arena Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Gastric emptying half-life (t½) as determined by scintigraphic imaging of radiolabeled meal		up to 4 hours 10 minutes after consumption of radiolabeled meal
Secondary	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
Secondary	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
Secondary	Gastric emptying after radiolabeled meal		at 2 hours ± 10 minutes and 4 hours ± 10 minutes after consumption of radiolabeled meal
Secondary	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