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

Arena Pharmaceuticals

Status and phase: Terminated; Phase 1

Conditions: Irritable Bowel Syndrome

Treatments: Drug: Olorinab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04655599

APD371-106

Details and patient eligibility

About

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

Full 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).

Enrollment: 1 patient

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

1 participants in 2 patient groups, including a placebo group

Olorinab, Then Placebo

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Olorinab

Placebo, Then Olorinab

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Olorinab