A Study Designed to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD5462 and the Absolute Bioavailability of AZD5462
NCT ID: NCT06989983
Last Updated: 2025-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
8 participants
INTERVENTIONAL
2025-05-20
2025-06-25
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AZD5462
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.
AZD5462 film-coated tablet
Oral, fasted
[14C]AZD5462 Solution for Infusion
Intravenous, fasted
[14C]AZD5462 Oral Solution
Oral, fasted
Interventions
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AZD5462 film-coated tablet
Oral, fasted
[14C]AZD5462 Solution for Infusion
Intravenous, fasted
[14C]AZD5462 Oral Solution
Oral, fasted
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
30 Years
65 Years
MALE
Yes
Sponsors
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Quotient Sciences
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Philip Evans, MBChB, MRCS (Ed)
Role: PRINCIPAL_INVESTIGATOR
Quotient Sciences
Locations
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Research Site
Ruddington, , United Kingdom
Countries
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Other Identifiers
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D9090C00009
Identifier Type: -
Identifier Source: org_study_id
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