Clinical trial NCT04655599: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Irritable Bowel Syndrome
Keywords: Olorinab
APD371
Irritable bowel syndrome
IBS
IBS with predominant constipation
IBS-C
IBS with predominant diarrhea
IBS-D
Lead sponsor: Arena Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-12-07
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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).

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)

Primary outcomes:
measure: Colonic transit geometric center after consumption of radiolabeled meal, based on the delivery of activated charcoal in a methacrylate-coated capsule
timeFrame: up to 24 hours 30 minutes after consumption of radiolabeled meal
measure: Gastric emptying half-life (t½) as determined by scintigraphic imaging of radiolabeled meal
timeFrame: up to 4 hours 10 minutes after consumption of radiolabeled meal
Secondary outcomes:
measure: Colonic transit geometric center after consumption of radiolabeled meal, based on the delivery of activated charcoal in a methacrylate-coated capsule
timeFrame: up to 48 hours 30 minutes after consumption of radiolabeled meal
measure: Ascending colon emptying t½ of radiolabeled activated charcoal particles delivered in a methacrylate-coated capsule
timeFrame: up to 24 hours 30 minutes after consumption of radiolabeled meal
measure: Gastric emptying after radiolabeled meal
timeFrame: at 2 hours ± 10 minutes and 4 hours ± 10 minutes after consumption of radiolabeled meal
measure: Number and severity of adverse events
timeFrame: Up to approximately 6 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Arena Pharmaceuticals
name: Arena CT.gov Administrator
role: STUDY_DIRECTOR
References: