To assess safety and tolerability and establish efficacy of LJN452 in patients with primary bile acid diarrhea.

Phase 1

Active, not recruiting

• Conditions: primary bile acid diarrhea; MedDRA version: 20.0 Level: LLT Classification code 10032786 Term: Other specified intestinal malabsorption System Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-003192-30-GB
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-30
• Study Completion: 2018-01-25
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

• A history of diarrheal symptoms for at least 3 months prior to dosing - Average stool frequency of at least 3 per day when off therapy AND Average stool form of >5 on Bristol Stool Chart.
•Previous laboratory or radiological confirmation of bile acid
malabsorption within the last 5 years with either fecal bile acid loss of =2,000 µmol per 48 hours OR 7 day 75Selenium
homocholic acid taurine (75SeHCAT) retention.
• Age = 18 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

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.
•History of extrahepatic biliary obstructive disease or complete biliary obstruction.
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception.
• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified