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

Primary Purpose

Irritable Bowel Syndrome

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Olorinab
Placebo
Sponsored by
Arena Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Irritable Bowel Syndrome focused on measuring Olorinab, APD371, Irritable bowel syndrome, IBS, IBS with predominant constipation, IBS-C, IBS with predominant diarrhea, IBS-D

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Olorinab, Then Placebo

Placebo, Then Olorinab

Arm Description

Participants will first receive olorinab, followed by a washout period, and they then will receive placebo.

Participants will first receive placebo, followed by a washout period, and they then will receive olorinab.

Outcomes

Primary Outcome Measures

Colonic transit geometric center after consumption of radiolabeled meal, based on the delivery of activated charcoal in a methacrylate-coated capsule
Gastric emptying half-life (t½) as determined by scintigraphic imaging of radiolabeled meal

Secondary Outcome Measures

Colonic transit geometric center after consumption of radiolabeled meal, based on the delivery of activated charcoal in a methacrylate-coated capsule
Ascending colon emptying t½ of radiolabeled activated charcoal particles delivered in a methacrylate-coated capsule
Gastric emptying after 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.

Full Information

First Posted
November 19, 2020
Last Updated
May 13, 2021
Sponsor
Arena Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04655599
Brief Title
Effect of Olorinab on Gastrointestinal Transit in Patients With Irritable Bowel Syndrome
Official Title
Effect of Olorinab on Gastrointestinal Transit in Patients With Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
Strategic business decision
Study Start Date
January 29, 2021 (Actual)
Primary Completion Date
April 13, 2021 (Actual)
Study Completion Date
April 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arena Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Olorinab, APD371, Irritable bowel syndrome, IBS, IBS with predominant constipation, IBS-C, IBS with predominant diarrhea, IBS-D

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Olorinab, Then Placebo
Arm Type
Experimental
Arm Description
Participants will first receive olorinab, followed by a washout period, and they then will receive placebo.
Arm Title
Placebo, Then Olorinab
Arm Type
Placebo Comparator
Arm Description
Participants will first receive placebo, followed by a washout period, and they then will receive olorinab.
Intervention Type
Drug
Intervention Name(s)
Olorinab
Intervention Description
Olorinab tablet by mouth, 3 times a day for 4 days with a final dose on Day 5.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Olorinab matching placebo tablet by mouth, 3 times a day for 4 days with a final dose on Day 5.
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Gastric emptying after radiolabeled meal
Time Frame
at 2 hours ± 10 minutes and 4 hours ± 10 minutes after consumption of radiolabeled meal
Title
Number and severity of adverse events
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arena CT.gov Administrator
Organizational Affiliation
Arena Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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