Healthy Participants
Conditions
Keywords
Pharmacokinetics, Pharmacodynamics, Repeated dosing, Dyslipidemia, Elevated low-density lipoprotein cholesterol
Brief summary
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.
Detailed description
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.
Interventions
DRUGAZD0780
AZD0780 will be administered orally.
DRUGPlacebo
Placebo will be administered orally.
Sponsors
AstraZeneca
Parexel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy participants with suitable veins for cannulation or repeated venipuncture. * All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit. * Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception. * Females of non-childbearing potential must be confirmed as postmenopausal or have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion. * Have a body mass index between 18 and 35 kg/m2 inclusive and weigh at least 50 kg. * Fasting LDL-C ≥ 70 mg/dL and \< 190 mg/dL at Screening.
Exclusion criteria
* History of any clinically important disease or disorder. * 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 important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration. * Any abnormal vital signs or laboratory values including clinical chemistry, hematology, coagulation, or urinalysis results. * Current smokers or those who have smoked or used nicotine products (including e-cigarettes) or any known or suspected history of alcohol or drug abuse. * History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, especially to drugs with a similar chemical structure or class to AZD0780.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative change from baseline in LDL-C levels | From Baseline (Day 1) to 4 weeks | To determine the pharmacodynamic profile of AZD0780 versus placebo by evaluating LDL-C concentrations after repeated oral administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under concentration-time curve from time 0 to infinity (AUCinf) | At pre-defined intervals from Day 1 to Day 40 | To characterize the single dose and steady state pharmacokinetics (PK) of AZD0780 following oral administration of AZD0780 |
| Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) | At pre-defined intervals from Day 1 to Day 40 | To characterize the single dose and steady state PK of AZD0780 following oral administration of AZD0780 |
| Maximum observed drug concentration (Cmax) | At pre-defined intervals from Day 1 to Day 40 | To characterize the single dose and steady state PK of AZD0780 following oral administration of AZD0780 |
| Number of participants with adverse events (AEs) and serious adverse events (SAEs) | Upto Day 40 | To assess the safety and tolerability of AZD0780 versus placebo following oral administration of repeated dosing in healthy participants |
Countries
United States
Outcome results
None listed