Patients with dyslipidemia but otherwise without symptoms/signs of disease MedDRA version: 12.1 Level: LLT Classification code 10058110 Term: Dyslipidemia
Conditions
Interventions
Product Name: A3309
Product Code: A3309
Pharmaceutical Form: Tablet
Current Sponsor code: A3309
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical fo
Sponsors
Albireo AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Dyslipidemia as measured by Total cholesterol evaluation and evaluation of other lipid parameter Male or non-pregnant females aged 18 to 80 years inclusive, with body mass index (BMI) 18.5 to 35 inclusive; Loose stools not present more often than once a month; Female subjects of childbearing potential, must have a negative serum pregnancy test at the Screening Visit (Clinic Visit 1); The patient agrees to refrain from making any new, major life-style changes that may affect the metabolism (i.e., starting a new diet, changing an exercise plan) from the time of signing the ICF through to the last study visit 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: History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks prior to the first administration of IMP Known cardiovascular disease or manifestation of atherosclerosis Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus (HIV) S-Cholesterol >8.5 mmol/L S-Triglycerides > 4 mmol/L Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator Any clinically significant findings on a Screening physical examination or 12 lead ECG Known or suspected history of drug or alcohol abuse as judged by the investigator Positive screen for alcohol and/or drugs of abuse at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary efficacy objective of this Phase IIa study is to assess the efficacy of two dose levels of multiple doses of A3309 in patients with dyslipidemia;Secondary Objective: Secondary objectives of this study include assessment of the safety and tolerability of two dose levels of multiple doses of A3309 in patients with dyslipidemia;Primary end point(s): Change from baseline in Total cholesterol and LDL cholesterol | — |
Countries
Sweden
Outcome results
None listed