To Assess Safety, Tolerability and Efficacy of LJN452 in Patients With Primary Bile Acid Diarrhea.



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:1/10/2019
Start Date:January 16, 2016
End Date:January 25, 2018

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A Double Blind, Randomized Placebo Controlled Crossover Multiple Dose Study of LJN452 to Assess Safety, Tolerability and Efficacy in Patients With Primary Bile Acid Diarrhea (pBAD).

The purpose of this study is to determine whether LJN452 improves the symptoms of bile acid
diarrhea and to assess its safety and tolerability profile in patients with primary bile acid
diarrhea (pBAD) to guide decision-making regarding further clinical development in this
indication.


Key Inclusion Criteria:

- A history of diarrheal symptoms for at least 3 months prior to dosing - Average stool
frequency of at least 2 per day when off therapy AND Average stool form of >5 on
Bristol Stool Chart.

- Previous laboratory or radiological confirmation of bile acid malabsorption with
either fecal bile acid loss OR 7 day 75Selenium homocholic acid taurine (75SeHCAT)
retention.

- Age ≥ 18 years.

Key Exclusion Criteria:

- Patients with other diagnoses leading to diarrhea, including colorectal neoplasia,
ulcerative colitis, Crohn's disease, celiac disease, chronic pancreatitis,
drug-induced diarrhea or active infection AND Patients who have not been investigated
by standard clinical assessments to exclude these disorders.

- Treatment with bile acid sequestrants (colestyramine, colestipol, colesevelam) for 2
weeks before the first dose of LJN452. A washout of 14 days for these agents will be
allowed before first dosing.

- Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant.

- A positive Hepatitis B surface antigen or Hepatitis C test result.

- History of immunodeficiency diseases, including a positive HIV (ELISA and Western
blot) test result.
We found this trial at
2
sites
Rochester, Minnesota 55905
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Rochester, MN
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Harrow, Middlesex
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Harrow,
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