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A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics With AZD0780 Following Repeated Dose Administration in Healthy Adults With Elevated LDL-C Levels
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics With AZD0780 Following Repeated Dose Administration in Healthy Adults With Elevated LDL-C Levels
CompletedPhase 1
Sponsor: AstraZeneca
Conditions: Healthy Participants
Interventions: AZD0780, Placebo
Countries: United States
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.
Eligibility overview
Sex: ALL
Age: 18 Years to 65 Years
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Eligibility criteria
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.
Locations (1)
- Brooklyn, Maryland, United States