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

May 13, 2021 updated by: Arena Pharmaceuticals
A Phase 1b study to determine the effect of oral olorinab on gastrointestinal transit in adult participants with irritable bowel syndrome (IBS).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Olorinab, Then Placebo
Participants will first receive olorinab, followed by a washout period, and they then will receive placebo.
Drug: Olorinab
Olorinab tablet by mouth, 3 times a day for 4 days with a final dose on Day 5.
Drug: Placebo
Olorinab matching placebo tablet by mouth, 3 times a day for 4 days with a final dose on Day 5.
Placebo Comparator: Placebo, Then Olorinab
Participants will first receive placebo, followed by a washout period, and they then will receive olorinab.
Drug: Olorinab
Olorinab tablet by mouth, 3 times a day for 4 days with a final dose on Day 5.
Drug: Placebo
Olorinab matching placebo tablet by mouth, 3 times a day for 4 days with a final dose on Day 5.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
up to 4 hours 10 minutes after consumption of radiolabeled meal

Secondary Outcome Measures

Outcome Measure
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
Time Frame: up to 48 hours 30 minutes after consumption of radiolabeled meal
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
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
at 2 hours ± 10 minutes and 4 hours ± 10 minutes after consumption of radiolabeled meal
Number and severity of adverse events
Time Frame: Up to approximately 6 weeks
Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
Up to approximately 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arena Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2021

Primary Completion (Actual)

April 13, 2021

Study Completion (Actual)

April 13, 2021

Study Registration Dates

First Submitted

November 19, 2020

First Submitted That Met QC Criteria

December 4, 2020

First Posted (Actual)

December 7, 2020

Study Record Updates

Last Update Posted (Actual)

May 17, 2021

Last Update Submitted That Met QC Criteria

May 13, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APD371-106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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