A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD0780 in Healthy Subjects

• Status: Not yet recruiting
• Trial end date: 2023-06-27
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD0780 following single and multiple dose administration to healthy subjects with or without elevated Low-Density Lipoprotein-Cholesterol (LDL-C) levels.

This study will consist of two parts (Parts A and B).

56 subjects have been planned for Part A and 76 subjects for Part B. Additional subjects may be included for the optional cohorts depending upon emerging data.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Parexel

Criteria

Inclusion Criteria:

• Females must have a negative pregnancy test at the Screening Visit and on admission to the study center, must not be lactating, and must be of non-childbearing potential confirmed at the Screening Visit.

• For Japanese subjects (Part B) and Chinese subjects (Part A): (i) A subject will be considered Japanese if both parents and all grandparents are Japanese, the subject was born in Japan, and the subject has not lived outside Japan for more than 10 years.

(ii) A subject will be considered Chinese if both parents and all grandparents are Chinese, the subject was born in China, and the subject has not lived outside China for more than 10 years.

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 of IMP.

• Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) first vaccination within 30 days prior to randomization.

• SARS-CoV-2 second vaccination within 10 days of screening.

• Confirmed Coronavirus disease 2019 (COVID-19) infection during screening and admission, by Polymerase Chain Reaction (PCR) test.

• Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results.

• Any positive result on Screening for serum hepatitis B surface antigen, hepatitis C antibody, and Human immunodeficiency virus (HIV).

• Abnormal vital signs after 10 minutes supine rest at the Screening Visit and on admission to the study center.

• Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12-lead ECG that may interfere with the interpretation of ECG interval measured from the onset of the QRS complex to the end of the T wave (QT) corrected for heart rate (QTc) interval changes including abnormal ST-T-wave morphology at the Screening Visit and/or on admission to the study center.

• Known or suspected history of drug abuse.

• Current smokers or those who have smoked or used nicotine products within the previous 3 months.

• History of alcohol abuse or excessive intake of alcohol.

• Positive screen for drugs of abuse or cotinine at Screening or admission to the study center or positive screen for alcohol on admission to the study center prior to the first administration of the IMP.

• History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD0780.

• Excessive intake of caffeine-containing drinks or food.

• Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP.

• Use of any prescribed or nonprescribed medication including antacids, analgesics, herbal remedies, mega-dose vitamins, and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half-life.

• Plasma donation within one month of the Screening Visit or any blood donation/blood loss during the 3 months prior to the Screening Visit.

• Has received another new chemical entity within 30 days or 5 half-lives of the first administration of IMP in this study.

• Subjects who have previously received AZD0780.

• Involvement of any Astra Zeneca or study center employee or their close relatives.

• Any ongoing or recent minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.

• Subjects who are vegans or have medical dietary restrictions.

• Subjects who cannot communicate reliably with the investigator.

• Vulnerable subjects.