NCT06989983CompletedPhase 1
A Study Designed to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD5462 and the Absolute Bioavailability of AZD5462
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
Source: ClinicalTrials.gov · Last updated 4 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- First submitted
- 5 May 2025
- Start date
- 20 May 2025
- Primary completion date
- 25 Jun 2025
- Lead sponsor
- AstraZeneca
- Diseases
- Heart failure
- NCT number
- NCT06989983
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 8
- From 20 May 2025 to the primary completion date, 25 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
- Current smokers or known or suspected history of alcohol or drug abuse
Other
- 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
- Excessive intake of caffeine-containing drinks or food
Who the study is looking for
- 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)
Age in the registry: 30 years to 65 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Site Coordinator of this site? Confirm its status | Ruddington | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.