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

NCT04655599 | Terminated Phase 1 FDA Drug

• 1 other identifier: APD371-106
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Irritable Bowel Syndrome

Keywords

Olorinab; APD371; Irritable bowel syndrome; IBS; IBS with predominant constipation; IBS-C; IBS with predominant diarrhea; IBS-D

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• 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

• 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

Study Arms (2)

Olorinab, Then Placebo

EXPERIMENTAL

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

Drug: Olorinab; Drug: Placebo

Placebo, Then Olorinab

PLACEBO COMPARATOR

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

Drug: Olorinab; Drug: Placebo

Interventions

Olorinab DRUG

Olorinab tablet by mouth, 3 times a day for 4 days with a final dose on Day 5.

Olorinab, Then Placebo; Placebo, Then Olorinab

Placebo DRUG

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

Olorinab, Then Placebo; Placebo, Then Olorinab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Arena Pharmaceuticals: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

olorinab

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Arena CT.gov Administrator

  Arena Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 7, 2020
• Study Start: January 29, 2021
• Primary Completion: April 13, 2021
• Study Completion: April 13, 2021
• Last Updated: May 17, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)