A Study to Assess the Effect AZD4831 in Japanese and Chinese Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Heart Failure With Preserved Ejection Fraction (HFpEF)

In brief

This study is randomized, single-blind, placebo-controlled Phase 1 study aimed to assess the safety and efficacy, pharmacokinetics and pharmacodynamics of multiple doses of oral AZD4831 in healthy Japanese and Chinese volunteers

Key facts

Study ID

NCT04232345

Run by

AstraZeneca

People needed

32

Starts

2020-01-16

Expected to finish

2021-03-11

Last updated by the study team

2021-04-01

Who can join

Age: 18 and older, up to 50. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Provision of signed and dated, written informed consent prior to any study specific procedures.
• Healthy male Japanese and Chinese subjects aged 18 - 50 years (inclusive at Screening) with suitable veins for cannulation or repeated venipuncture.
• A Japanese subject is defined as having both parents and 4 grandparents who are ethnically Japanese. This includes second and third generation Japanese whose parents or grandparents are living in a country other than Japan.
• A Chinese subject is defined as having both parents and 4 grandparents who are ethnically Chinese. This includes second and third generation Chinese whose parents or grandparents are living in a country other than China.
• Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
• Provision of signed, written and dated informed consent for optional genetic/biomarker research. If a subject decline to participate in the genetic component of the study, there will be no penalty or loss of benefit to the subject. The subject will not be excluded from other aspects of the study described in this protocol.

You may not qualify if…

• History of any clinically important 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.
• Presence of infection(s) (particularly fungal infection), as judged by the Investigator.
• History of, or current thyroid disease.
• Any ongoing skin disorder, history of or ongoing clinically significant allergy/hypersensitivity.
• Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational medicinal product (IMP).
• Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, as judged by the Investigator at Screening and/or Day -1.
• Alanine transaminase (ALT) not within normal range
• Aspartate aminotransferase (AST) not within normal range
• Creatinine not within normal range
• White blood cell (WBC) count not within normal range
• Hemoglobin not within normal range;
• Estimated Glomerular Filtration Rate (eGFR) not within normal range.
• Any positive result at Screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus (HIV) type 1 and 2.
• Abnormal vital signs, after 10 minutes supine rest, at Screening and/or Day -1, defined as any of the following:
• SBP < 90 mmHg or ≥ 140 mmHg.
• DBP < 50 mmHg or ≥ 90 mmHg.
• Pulse < 45 or > 85 bpm.
• Any clinically significant abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and/or any clinically significant abnormalities in the 12-lead ECG, as judged by the Investigator that may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology, particularly in the protocol defined primary lead or left ventricular hypertrophy at Screening and/or Day -1.
• Prolonged QTcF > 450 ms or shortened QTcF < 340 ms or family history of long QT syndrome at Screening and/or Day -1.
• PR(PQ) interval shortening < 120 ms (PR > 110 ms but < 120 ms is acceptable if there is no evidence of ventricular pre-excitation) at Screening and/or Day -1.
• PR(PQ) interval prolongation (> 240 ms) intermittent second (Wenckebach block while asleep is not exclusive) or third-degree atrioventricular (AV)-block, or AV dissociation at Screening and/or Day -1.
• Persistent or intermittent complete bundle branch block, incomplete bundle branch block, or interventricular conduction delay with QRS > 110 ms. Subjects with QRS > 110 ms but < 115 ms are acceptable if there is no evidence of, for example, ventricular hypertrophy or pre-excitation at Screening and/or Day -1.
• Electrocardiogram findings suggesting a metabolic or other non-cardiac condition that may confound interpretation of serial changes (such as hypokalemia) at Screening and/or Day -1.
• Known or suspected history of drug abuse as judged by the Investigator.

Where it is running

• Research Site — Glendale, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.