A Study Designed to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD5462 and the Absolute Bioavailability of AZD5462

AstraZeneca

Status and phase: Not yet enrolling; Phase 1

Conditions: Heart Failure

Treatments: Drug: AZD5462 film-coated tablet; Drug: [14C]AZD5462 Oral Solution; Drug: [14C]AZD5462 Solution for Infusion

Study type: Interventional

Funder types: Industry

Identifiers

NCT06989983

D9090C00009

Details and patient eligibility

About

A study to investigate how the body breaks down and gets rid of the test medicine, AZD5462.

To help investigate this, the test medicine is radiolabelled, which means that the test medicine has a radioactive component (carbon-14), which helps us to track where the test medicine is in the body. The safety and tolerability of the test medicine will also be studied.

Full description

This is an open-label, two-period study designed to assess the mass balance recovery, absorption, metabolism, excretion of [14C]AZD5462 and the absolute bioavailability of AZD5462 in healthy male participants.

The study will take place at 1 site in Nottingham, and enrol 8 healthy men aged 30-65 years. The study will include 2 Periods:

• In Period 1 volunteers will receive a single dose of radiolabelled test medicine as a liquid by mouth.
• In Period 2 volunteers will receive a single dose of the test medicine as capsules by mouth and shortly afterwards, a very tiny dose of radiolabelled study medicine by injection into a vein.

The participants will be resident in the clinical unit throughout both study periods for a total of 12 nights. The total study duration is approximately up to 6 weeks.

Enrollment: 8 estimated patients

Sex: Male

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males aged 30 to 65 years inclusive
• BMI in the range 18.0 - 32.0 kg/m2 inclusive and body weight ≥ 50 kg and ≤ 100 kg
• Regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day)

Exclusion criteria

• History of any clinically significant disease or disorder
• History or presence of clinically significant gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
• History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity
• History of active malignancy within 2 years, or under investigation for any form of cancer
• Participants who do not have suitable veins for multiple venepunctures/cannulation
• Clinically significant abnormal clinical chemistry, haematology or urinalysis
• Any clinically significant abnormalities in vital signs
• Any clinically significant abnormalities on 12-lead ECG
• Abnormal renal function
• Radiation exposure exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years, occupationally exposed worker, or have been administered IMP in a radiolabelled ADME study in the last 12 months.
• Use of any prescribed or non-prescribed medication including antacids, analgesics, herbal remedies, vitamins and minerals
• Current smokers or known or suspected history of alcohol or drug abuse
• Excessive intake of caffeine-containing drinks or food

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

AZD5462

Experimental group

Description:

In Period 1, participants will receive one oral dose of \[14C\]AZD5462. In Period 2, participants will receive one oral dose of AZD5462 and one intravenous dose of \[14C\]AZD5462.

Treatment:

Drug: [14C]AZD5462 Solution for Infusion

Drug: AZD5462 film-coated tablet

Drug: [14C]AZD5462 Oral Solution