A Bioavailability and Food Effect Study of AZD5462 in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy Participants

In brief

This study will assess the pharmacokinetics of AZD5462 film-coated tablet formulation in healthy participants.

Key facts

Study ID

NCT05512806

Run by

AstraZeneca

People needed

16

Starts

2022-08-24

Expected to finish

2022-11-07

Last updated by the study team

2023-11-09

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Provision of signed and dated, written informed consent prior to any study specific procedures.
• Healthy male and female participants aged 18 to 55 years at screening and admission with suitable veins for cannulation or repeated venipuncture.
• Females must have a negative pregnancy test at screening and on admission to the study center, must not be lactating and must be of non-childbearing potential confirmed at screening by fulfilling one of the following criteria:
• Postmenopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and Follicle-stimulating hormone (FSH)/Luteinizing hormone (LH) levels in the postmenopausal range.
• Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
• Male participant must adhere to the contraception methods details.
• Have a Body mass index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 50 kg and no more than 105 kg inclusive at screening.

You may not qualify if…

• History of any clinically significant disease or disorder which may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
• Any of the below conditions:
• Systemic sclerosis.
• Moderate to severe valvular disease.
• Hypertrophic obstructive cardiomyopathy.
• Restrictive cardiomyopathy.
• Gilbert's syndrome.
• History of vascular or left ventricular aneurysms, or prior dissections.
• Any history of joint hypermobility, Marfan's Syndrome, or any connective tissue 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 significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of Investigational medicinal product (IMP).
• Any laboratory values with the following deviations at screening, or admission to the study center:
• Total bilirubin > Upper limit of normal (ULN).
• Alanine aminotransferase > 1.5 × ULN.
• Aspartate aminotransferase > 1.5 × ULN.
• Estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73m2, as assessed by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
• White blood cell count < 3.5 k/uL and > ULN.
• Hemoglobin < Lower limit of normal (LLN).
• Any clinically significant abnormalities in clinical biochemistry, hematology, or urinalysis results.
• Any clinically significant abnormal findings in vital signs after 5 minutes supine rest, at screening or admission defined as any of the following:
• Systolic Blood pressure (BP) < 90 mmHg or ≥ 140 mmHg.
• Diastolic BP < 50 mmHg or ≥ 90 mmHg.
• Heart rate < 50 bpm or > 90 bpm.
• Any clinically important abnormalities in rhythm, conduction or morphology of the resting 12-lead Electrocardiogram (ECG) at screening or admission.
• Prolonged QTcF > 450 ms.

Where it is running

• Research Site — Brooklyn, Maryland, United States

Full record on ClinicalTrials.gov

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