early stage primary biliary cirrhosis PBC
Conditions
Interventions
All subjects: treatment with study medication (UDCA) for 21 days
Patients pretreated with UDCA: 6 weeks UDCA-washout
Sponsors
Dr. Falk Pharma GmbH
Eligibility
Age
18 Years to 99 Years
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 wih 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.
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; existing disorders of the coagulation system or treatment with anticoagulants or agents inhibiting thrombocyte aggregation; 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 |
|---|---|
| SAFETY CRITERIA: Physical examination, ECG, vital signs, laboratory evaluations and adverse events; PHARMACOKINETIC PARAMETERS: Bile acids and bile acid metabolites; PHARMACODYNAMIC PARAMETERS: Expressions of transporters and drug metabolizing enzymes. | — |
Countries
Netherlands
Outcome results
None listed