primary bile acid diarrhea MedDRA version: 20.0 Level: LLT Classification code 10032786 Term: Other specified intestinal malabsorption System Organ Class: 100000004856
Conditions
Interventions
Product Code: LJN452
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Not established yet
Other descriptive name: LJN452
Concentr
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •Safety and tolerability •clinical symptoms ; Secondary Objective: •the pharmacokinetics of LJN452 •effect of LJN452 on use of rescue ; Primary end point(s): • Safety endpoints include type and frequency of adverse events, serious adverse events, and laboratory, vital signs, physical, and ECG abnormalities. •Change from baseline in stool frequency and stool form per Bristol Stool Chart. ; Timepoint(s) of evaluation of this end point: •across all visits •predose, end of treatment period 1 and period 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Tmax, Cmax and AUCtau of LJN452. •Use and type of rescue medications ; Timepoint(s) of evaluation of this end point: •Day 1 and Day 12 in each treatment period •all visits | — |
Countries
Germany, United Kingdom, United States
Contacts
Public ContactMedica Information Services
Novartis Pharmaceuticals UK Limited
Outcome results
None listed