Status:
COMPLETED
A Study Designed to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD5462 and the Absolute Bioavailability of AZD5462
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Quotient Sciences
Conditions:
Heart Failure
Eligibility:
MALE
30-65 years
Phase:
PHASE1
Brief Summary
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 radi...
Detailed 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 pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2025
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06989983
Start Date
May 20 2025
End Date
June 25 2025
Last Update
July 4 2025
Active Locations (1)
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1
Research Site
Ruddington, United Kingdom, NG11 6JS