Eluxadoline Bile Acid Malabsorption (BAM) Study
Condition: Irritable Bowel Syndrome With Diarrhea
MeSH terms: Irritable Bowel Syndrome; Malabsorption Syndromes; Syndrome; Diarrhea
Intervention: Eluxadoline
Intervention description: Eluxadoline 100 mg oral tablets BID with food.
Intervention MeSH terms: Eluxadoline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: IBS-D; BAM

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).
    

Eligibility 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.