Pharmacokinetic and safety study of HTD1801 and its components

Category Primary study
Registry of TrialsANZCTR
Year 2017
INTERVENTION: The treatments are HTD1801, 1500mg, BBR 1000mg and UDCA 1000mg, one oral dose of each treatment. There will be a washout period of at least 7 days and up to 10 days.. Participants will be admitted to the treatment unit where the investigational products will be administered. CONDITION: Primary Sclerosing Cholangitis (PSC) PRIMARY OUTCOME: Primary endpoint: ; AUC0‐t. This is assessed by obtaining the plasma concentration of each investigational product. ; SECONDARY OUTCOME: Adverse Events (AES). AEs will be measured through communication with the participants and through performing physical examinations. Blood chemistry will be measured. Components are: ; Urea ; Creatinine ; AST ; ALT ; Alkaline Phosphatase ; Total Bilirubin ; Blood haematology. Components are: ; Haemoglobin ; Haematocrit ; RBC Count ; Platelets Count ; WBC Count ; Neutrophils ; Lymphocytes ; Monocytes ; Eosinophils ; Basophils Cmax. ECGs. The electrical activity of the heart will be measured. Secondary endpoint: ; Tmax ; T1/2 Vital signs will be measured by measuring heart rate, blood pressure, respiratory rate and temperature. INCLUSION CRITERIA: Males and females 18‐45 years of age BMI 20‐35 kg/m2 No history of CV or any other major disease No pathologies in blood haematology or chemistry
Epistemonikos ID: 3652e7b058c4225455bf126b6818ad22c2e818ef
First added on: Aug 23, 2024