Primary Biliary Cirrhosis Stage I-III MedDRA version: 12.1 Level: LLT Classification code 10036680 Term: Primary biliary cirrhosis
Conditions
Interventions
Trade Name: Ursofalk® 500 mg Filmtabletten
Product Name: Ursofalk® 500 mg Filmtabletten
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ursodeoxycholic acid
CAS Number: 128-13-2
Concentra
Sponsors
Dr. Falk Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects: Male or female, adult, body mass index in the range of 18-30 kg/m2, able to give fully informed written consent, clinically acceptable vital signs and ECG. Patients: Positive anti-mitochondrial antibody testing, alkaline phosphatase or gamma-glutamyl-transpeptidase = 1.5 above normal at initial diagnosis, and within 5 years prior to inclusion histologically proven non-cirrhotic liver disease compatible with PBC stage I, II, II-III and no reliable signs of portal hypertension such as esophageal varices or ascites and/or pylephlebectasia > 15 mm. Volunteers: Non-smokers, routine laboratory parameters within their normal range or deviations from normal range not clinically relevant according to the investigator. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: All subjects: Existing cardiac, hematological, renal, gastrointestinal (other than PBC) diseases and/or pathological findings which might interfere with the drugs' safety, tolerability, absorption, pharmacokinetics and/or endoscopy; other acute or chronic diseases which might affect absorption or metabolism of UDCA; alcohol abuse; positive anti-HIV-test or HBs-Ag-test or anti-HCV-test; intake of cholestyramine or H2-antagonists within the last 3 days prior to first administration of study drug and during the study; intake of antacids within 12 hours prior to first administration of study drug and during the study; repeated intake of drugs which might interfere with gastrointestinal absorption and motility within the last 3 days prior to first administration of study drug and during the study; known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations; acute inflammation of the gallbladder or bile duct system; obstruction of the bile ducts; acute hepatitis; patients/volunteers suspected not be able to understand or follow instructions; patients/volunteers in financial difficulties; blood donation or other blood loss of more than 400 ml within the previous 2 months; women of child-bearing potential without two independent methods of contraception. Patients: Any other hepatic disease of metabolic, viral and/or toxic origin, secondary biliary cirrhosis, other autoimmune hepatitis than PBC; clinically relevant pathological laboratory findings not related to hepatic disorder; histologically proven cirrhotic liver disease or total bilirubin > 3 mg/dl or reliable signs of portal hypertension; complete thrombosis of the portal vein; heavy smokers; pregnant/lactating women; intake of UDCA in the 6 weeks prior to Study Day 1; increases in at least two of the following five liver parameters by = 4 times the upper limit of normal after 4 weeks of UDCA wash-out: AST, ALT, ?-GT, total bilirubin, alkaline phosphatase. Volunteers: History or clinical evidence of any cardiac, cardio-vascular, hepatic, cholangiolar, renal, pulmonary, endocrine, neurologic, infectious, gastrointestinal, hematological, oncological, psychiatric disease or emotional problems or any other clinical relevant condition, physical finding, laboratory test abnormality which, in the opinion of the Investigator, would pose a significant risk to the volunteer, invalidate the giving of the informed consent or limit the ability of the volunteer to comply with study requirements or interfere otherwise with the conduct of the study, any medication within the last 14 days prior to or during the conduct of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To assess the bile acid composition of cystic bile and serum pharmacokinetics after a 3-week treatment with UDCA and to correlate pharmacokinetic parameters of UDCA in bile and serum during steady state. - To compare the composition of bile acids and bile acid metabolites in serum before and after a 3-week treatment with UDCA. - To investigate the influence of UDCA on transport proteins and enzymes in the duodenal wall. - To compare the composition of cystic bile, the pharmacokinetics of bile acids and bile acid metabolites in serum as well as the influence of UDCA on transport proteins and enzymes between patients suffering from PBC and healthy volunteers. - To assess the safety of UDCA treatment.;Secondary Objective: ;Primary end point(s): Pharmacokinetic parameters in serum and bile. | — |
Countries
Germany
Outcome results
None listed