Eluxadoline Bile Acid Malabsorption (BAM) Study

• Status: Completed
• Trial end date: 2020-04-28
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the possibility of a differential effect of eluxadoline on altered bowel function in Irritable Bowel Syndrome with Diarrhea (IBS-D) participants with and without evidence of Bile Acid Malabsorption (BAM).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: Eluxadoline

Criteria

Inclusion Criteria:

• Adult men or women aged 18 to 75 years inclusive with a diagnosis of IBS-D per Rome IV criteria.

• Participants with evidence of BAM must have a fasting serum 7a-hydroxy-4-cholesten-3-one (7αC4) level ≥ 52.5 ng/mL or total fecal bile acid (BA) > 2337 micromoles/48 hours (positive result) at screening or within 1 calendar year prior to screening.

• Participants without BAM must have a fasting serum 7αC4 level ≤ 47.1 ng/mL or total fecal BA < 2200 micromoles/48 hours (negative result) at screening or within 1 calendar year prior to screening.

• Has an average daily Bristol Stool Form Scale (BSFS) score ≥ 5.0 or ≥ 25% of diary entry days with a BSFS score of 6 or 7 during the 14 days prior to Day 1.

• Women of childbearing potential must use hormonal or double barrier contraception or maintain a monogamous relationship with a vasectomized male partner from the date of informed consent until 24 hours after final dose of study drug.

• Completed the electronic diary (eDiary) on ≥ 10 of the 14 days prior to Day 1.

• Has not used loperamide rescue medication on > 3 of the 14 days prior to Day 1.

Exclusion Criteria:

• Has a diagnosis of IBS with a subtype of irritable bowel syndrome with constipation (IBS-C), mixed IBS, or unsubtyped IBS per Rome IV criteria.

• Does not have a gallbladder.

• Has known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction. (Participants with a history of gallstones may be enrolled).

• Has a history of alcoholism, alcohol abuse or alcohol addiction, or drinks more than 3 alcoholic beverages per day.

• Has a history of pancreatitis; structural diseases of the pancreas, including known or suspected pancreatic duct obstruction.

• Has a history of mild, moderate, or severe hepatic impairment according to Child-Pugh classification. History or current diagnosis of inflammatory or immune-mediated gastrointestinal (GI) disorders.

• Has Celiac disease or a positive serological test for celiac disease.

• Has known lactose or fructose intolerance associated with diarrhea, abdominal pain or discomfort, that could confound assessments in the study.

• Women who are currently pregnant or nursing, or plan to become pregnant or nurse during the study.

• Has known allergies or hypersensitivity to opioids.