The purpose of this study is to evaluate pharmacodynamics (PD) of AZD0780 compared with placebo by assessment of low-density lipoprotein-cholesterol (LDL-C) levels following repeated oral dosing in healthy adults with elevated LDL-C levels.
This is a Phase I, randomized, single-blind, placebo-controlled study of AZD0780 in healthy adults with elevated LDL-C levels. The study comprises of: * An optional Pre-screening visit. * A Screening Period (maximum 28 days). * Admission to the Clinical Unit (Day -1). * A Treatment Period for administration of AZD0780 or placebo (Days 1 to 28). * Follow-up Visit 12 ± 2 days after the last study intervention dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Research Site
Brooklyn, Maryland, United States
RECRUITINGRelative change from baseline in LDL-C levels
To determine the pharmacodynamic profile of AZD0780 versus placebo by evaluating LDL-C concentrations after repeated oral administration
Time frame: From Baseline (Day 1) to 4 weeks
Area under concentration-time curve from time 0 to infinity (AUCinf)
To characterize the single dose and steady state pharmacokinetics (PK) of AZD0780 following oral administration of AZD0780
Time frame: At pre-defined intervals from Day 1 to Day 40
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
To characterize the single dose and steady state PK of AZD0780 following oral administration of AZD0780
Time frame: At pre-defined intervals from Day 1 to Day 40
Maximum observed drug concentration (Cmax)
To characterize the single dose and steady state PK of AZD0780 following oral administration of AZD0780
Time frame: At pre-defined intervals from Day 1 to Day 40
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
To assess the safety and tolerability of AZD0780 versus placebo following oral administration of repeated dosing in healthy participants
Time frame: Upto Day 40
AstraZeneca Clinical Study Information Center
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.