Heart FailurePhase 1NCT06989983
A Study Designed to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD5462 and the Absolute Bioavailability of AZD5462
A Phase 1 study testing AZD5462 film-coated tablet, [14C]AZD5462 Solution for Infusion and [14C]AZD5462 Oral Solution in people with Heart Failure, run by AstraZeneca at 1 site in United Kingdom.
Trial 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 radioactive component (carbon-14), which helps us to track where the test medicine is in the body. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- AZD5462 film-coated tablet, [14C]AZD5462 Solution for Infusion and [14C]AZD5462 Oral Solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 May 2025to 25 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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 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.
- Conditions
- Heart Failure
- Being tested
- AZD5462 film-coated tablet, [14C]AZD5462 Solution for Infusion, [14C]AZD5462 Oral Solution
- Keywords
- Heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5462 film-coated tabletDrug
Also called AZD5462
Oral, fasted
[14C]AZD5462 Solution for InfusionDrug
Also called AZD5462
Intravenous, fasted
[14C]AZD5462 Oral SolutionDrug
Also called AZD5462
Oral, fasted
| Study group | Role | What they receive |
|---|---|---|
| AZD5462 | Experimental | 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. Receives: Drug: AZD5462 film-coated tablet; Drug: [14C]AZD5462 Solution for Infusion; Drug: [14C]AZD5462 Oral Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of AZD5462 excreted (Ae) - Period 1
Mass balance recovery of total radioactivity of [14C]AZD5462 in urine and faecal samples
Measured: Urine and faecal samples collected from pre-dose until 168 hours post-dose
Amount of AZD5462 excreted expressed as a percentage of the dose administered (Fe) - Period 1
Mass balance recovery of total radioactivity of [14C]AZD5462 in urine and faecal samples
Measured: Urine and faecal samples collected from pre-dose until 168 hours post-dose
Cumulative amount of AZD5462 excreted (CumAe) - Period 1
Mass balance recovery of total radioactivity of [14C]AZD5462 in urine and faecal samples
Measured: Urine and faecal samples collected from pre-dose until 168 hours post-dose
Cumulative amount of AZD5462 excreted expressed as a percentage of the dose administered (CumFe) - Period 1
Mass balance recovery of total radioactivity of [14C]AZD5462 in urine and faecal samples
Measured: Urine and faecal samples collected from pre-dose until 168 hours post-dose
Absolute bioavailability - Period 2
Absolute bioavailability (F) based on AUC0-inf of oral and IV administration, adjusted for dose
Measured: Plasma sample collection from pre-dose to 72 hours post-dose
Secondary outcomes (29)
Time of maximum observed concentration (tmax) for AZD5462 and total radioactivity - Period 1
PK of AZD5462 and [14C]AZD5462 in plasma
Measured: Plasma sample collection from pre-dose to 168 hours post-dose
Maximum observed concentration (Cmax) for AZD5462 and total radioactivity - Period 1
PK of AZD5462 and [14C]AZD5462 in plasma
Measured: Plasma sample collection from pre-dose to 168 hours post-dose
Area under the curve from time 0 to the time of last measurable concentration (AUC0-t) for AZD5462 and total radioactivity - Period 1
PK of AZD5462 and [14C]AZD5462 in plasma
Measured: Plasma sample collection from pre-dose to 168 hours post-dose
Area under the curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUC0-extrap) for AZD5462 and total radioactivity - Period 1
PK of AZD5462 and [14C]AZD5462 in plasma
Measured: Plasma sample collection from pre-dose to 168 hours post-dose
Terminal elimination half-life (t1/2) for AZD5462 and total radioactivity - Period 1
PK of AZD5462 and [14C]AZD5462 in plasma
Measured: Plasma sample collection from pre-dose to 168 hours post-dose
First order rate constant associated with the terminal (log-linear) portion of the curve (λz) for AZD5462 and total radioactivity - Period 1
PK of AZD5462 and [14C]AZD5462 in plasma
Measured: Plasma sample collection from pre-dose to 168 hours post-dose
Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F) for AZD5462 and total radioactivity - Period 1
PK of AZD5462 and [14C]AZD5462 in plasma
Measured: Plasma sample collection from pre-dose to 168 hours post-dose
Renal clearance calculated using plasma AUC (CLR) for AZD5462 and total radioactivity - Period 1
PK of AZD5462 and [14C]AZD5462 in plasma and urine
Measured: Plasma sample collection from pre-dose to 168 hours post-dose
Apparent volume of distribution based on the terminal phase calculated using AUC(0 inf) after a single extravascular administration where F (fraction of dose bioavailable) is unknown (Vz/F) for AZD5462 and total radioactivity - Period 1
PK of AZD5462 and [14C]AZD5462 in plasma and urine
Measured: Plasma sample collection from pre-dose to 168 hours post-dose
Area under the curve (AUC) of circulating plasma total radioactivity (TR) or accounting for 10% or more of the dose in excreta - Period 1
Identification of the chemical structure of each metabolite accounting for more than 10% by AUC of circulating TR or accounting for 10% or more of the dose in urine and faeces
Measured: Plasma, urine and faecal samples from pre-dose until 168 hours post-dose
Blood:plasma concentration ratios - Period 1
Blood:plasma concentration ratios of total radioactivity
Measured: Whole blood samples and plasma samples collected from pre-dose until 168 hours post-dose
Amount of unchanged AZD5462 excreted in urine (Ae) - Period 2
Recovery of total radioactivity of [14C]AZD5462 in urine
Measured: Urine sample collection from pre-dose to 72 hours post-dose
Amount of unchanged AZD5462 excreted in urine expressed as a percentage of the radioactive dose administered (Fe) - Period 2
Recovery of total radioactivity of [14C]AZD5462 in urine
Measured: Urine sample collection from pre-dose to 72 hours post-dose
Cumulative amount of unchanged AZD5462 excreted in urine (CumAe) - Period 2
Recovery of total radioactivity of [14C]AZD5462 in urine
Measured: Urine sample collection from pre-dose to 72 hours post-dose
Cumulative amount of unchanged AZD5462 excreted in urine expressed as a percentage of the radioactive dose administered (CumFe) - Period 2
Recovery of total radioactivity of [14C]AZD5462 in urine
Measured: Urine sample collection from pre-dose to 72 hours post-dose
Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for AZD5462 and total radioactivity - Period 1
PK of AZD5462 and [14C]AZD5462 in plasma
Measured: Plasma sample collection from pre-dose to 168 hours post-dose
Time of maximum observed concentration (tmax) for AZD5462 and [14C]AZD5462 - Period 2
PK of AZD5462 and [14C]AZD5462 in plasma
Measured: Plasma sample collection from pre-dose to 72 hours post-dose
Maximum observed concentration (Cmax) for AZD5462 and [14C]AZD5462 - Period 2
PK of AZD5462 and [14C]AZD5462 in plasma
Measured: Plasma sample collection from pre-dose to 72 hours post-dose
Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for AZD5462 and [14C]AZD5462 - Period 2
PK of AZD5462 and [14C]AZD5462 in plasma
Measured: Plasma sample collection from pre-dose to 72 hours post-dose
Area under the curve from time 0 to the time of last measurable concentration (AUC0-t) for AZD5462 and [14C]AZD5462 - Period 2
PK of AZD5462 and [14C]AZD5462 in plasma
Measured: Plasma sample collection from pre-dose to 72 hours post-dose
Area under the curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUC0-extrap) for AZD5462 and [14C]AZD5462- Period 2
PK of AZD5462 and [14C]AZD5462 in plasma
Measured: Plasma sample collection from pre-dose to 72 hours post-dose
Terminal elimination half-life (t1/2) for AZD5462 and [14C]AZD5462 - Period 2
PK of AZD5462 and [14C]AZD5462 in plasma
Measured: Plasma sample collection from pre-dose to 72 hours post-dose
First order rate constant associated with the terminal (log-linear) portion of the curve (λz) for AZD5462 and [14C]AZD5462 - Period 2
PK of AZD5462 and [14C]AZD5462 in plasma
Measured: Plasma sample collection from pre-dose to 72 hours post-dose
Total body clearance calculated after a single IV administration (CL) for AZD5462 and [14C]AZD5462 - Period 2
PK of AZD5462 and [14C]AZD5462 in plasma
Measured: Plasma sample collection from pre-dose to 72 hours post-dose
Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F) for AZD5462 and [14C]AZD5462 - Period 2
PK of AZD5462 and [14C]AZD5462 in plasma
Measured: Plasma sample collection from pre-dose to 72 hours post-dose
Volume of distribution based on the terminal phase calculated using AUC(0-inf) after a single IV administration (Vz) for AZD5462 and [14C]AZD5462 - Period 2
PK of AZD5462 and [14C]AZD5462 in plasma
Measured: Plasma sample collection from pre-dose to 72 hours post-dose
Apparent volume of distribution at steady state after a single IV administration (Vss) for AZD5462 and [14C]AZD5462 - Period 2
PK of AZD5462 and [14C]AZD5462 in plasma
Measured: Plasma sample collection from pre-dose to 72 hours post-dose
Apparent volume of distribution based on the terminal phase calculated using AUC(0 inf) after a single extravascular administration where F (fraction of dose bioavailable) is unknown (Vz/F) for AZD5462 and [14C]AZD5462 - Period 2
PK of AZD5462 and [14C]AZD5462 in plasma
Measured: Plasma sample collection from pre-dose to 72 hours post-dose
Number of subjects with treatment-related adverse events - Periods 1 and 2
To provide additional safety and tolerability information for AZD5462
Measured: Through study duration, an average of 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start20 May 2025
- Primary completion25 Jun 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Responsible party
- Sponsor
- Investigators
- Philip Evans, MBChB, MRCS (Ed), Principal investigator, Quotient Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989983
- Sponsor's protocol ID
- D9090C00009
- Status last verified
- Jun 2025
- First submitted
- 5 May 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual participant-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06989983
- Acronym / sponsor ID
- D9090C00009
- Conditions
- Heart Failure
- Keywords
- Heart failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Study start
- 20 May 2025 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZD5462 | Experimental | Drug: AZD5462 film-coated tablet, Drug: [14C]AZD5462 Solution for Infusion, Drug: [14C]AZD5462 Oral SolutionIn 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD5462 film-coated tabletAlso: AZD5462Oral, fasted | Drug | AZD5462 |
| [14C]AZD5462 Solution for InfusionAlso: AZD5462Intravenous, fasted | Drug | AZD5462 |
| [14C]AZD5462 Oral SolutionAlso: AZD5462Oral, fasted | Drug | AZD5462 |
Primary outcome
Amount of AZD5462 excreted (Ae) - Period 1
Time frame: Urine and faecal samples collected from pre-dose until 168 hours post-dose
Mass balance recovery of total radioactivity of [14C]AZD5462 in urine and faecal samples
Amount of AZD5462 excreted expressed as a percentage of the dose administered (Fe) - Period 1
Time frame: Urine and faecal samples collected from pre-dose until 168 hours post-dose
Mass balance recovery of total radioactivity of [14C]AZD5462 in urine and faecal samples
Cumulative amount of AZD5462 excreted (CumAe) - Period 1
Time frame: Urine and faecal samples collected from pre-dose until 168 hours post-dose
Mass balance recovery of total radioactivity of [14C]AZD5462 in urine and faecal samples
Cumulative amount of AZD5462 excreted expressed as a percentage of the dose administered (CumFe) - Period 1
Time frame: Urine and faecal samples collected from pre-dose until 168 hours post-dose
Mass balance recovery of total radioactivity of [14C]AZD5462 in urine and faecal samples
Absolute bioavailability - Period 2
Time frame: Plasma sample collection from pre-dose to 72 hours post-dose
Absolute bioavailability (F) based on AUC0-inf of oral and IV administration, adjusted for dose
29 secondary outcomes
Time of maximum observed concentration (tmax) for AZD5462 and total radioactivity - Period 1
Time frame: Plasma sample collection from pre-dose to 168 hours post-dose
Maximum observed concentration (Cmax) for AZD5462 and total radioactivity - Period 1
Time frame: Plasma sample collection from pre-dose to 168 hours post-dose
Area under the curve from time 0 to the time of last measurable concentration (AUC0-t) for AZD5462 and total radioactivity - Period 1
Time frame: Plasma sample collection from pre-dose to 168 hours post-dose
Area under the curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUC0-extrap) for AZD5462 and total radioactivity - Period 1
Time frame: Plasma sample collection from pre-dose to 168 hours post-dose
Terminal elimination half-life (t1/2) for AZD5462 and total radioactivity - Period 1
Time frame: Plasma sample collection from pre-dose to 168 hours post-dose
First order rate constant associated with the terminal (log-linear) portion of the curve (λz) for AZD5462 and total radioactivity - Period 1
Time frame: Plasma sample collection from pre-dose to 168 hours post-dose
Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F) for AZD5462 and total radioactivity - Period 1
Time frame: Plasma sample collection from pre-dose to 168 hours post-dose
Renal clearance calculated using plasma AUC (CLR) for AZD5462 and total radioactivity - Period 1
Time frame: Plasma sample collection from pre-dose to 168 hours post-dose
Apparent volume of distribution based on the terminal phase calculated using AUC(0 inf) after a single extravascular administration where F (fraction of dose bioavailable) is unknown (Vz/F) for AZD5462 and total radioactivity - Period 1
Time frame: Plasma sample collection from pre-dose to 168 hours post-dose
Area under the curve (AUC) of circulating plasma total radioactivity (TR) or accounting for 10% or more of the dose in excreta - Period 1
Time frame: Plasma, urine and faecal samples from pre-dose until 168 hours post-dose
Blood:plasma concentration ratios - Period 1
Time frame: Whole blood samples and plasma samples collected from pre-dose until 168 hours post-dose
Amount of unchanged AZD5462 excreted in urine (Ae) - Period 2
Time frame: Urine sample collection from pre-dose to 72 hours post-dose
Amount of unchanged AZD5462 excreted in urine expressed as a percentage of the radioactive dose administered (Fe) - Period 2
Time frame: Urine sample collection from pre-dose to 72 hours post-dose
Cumulative amount of unchanged AZD5462 excreted in urine (CumAe) - Period 2
Time frame: Urine sample collection from pre-dose to 72 hours post-dose
Cumulative amount of unchanged AZD5462 excreted in urine expressed as a percentage of the radioactive dose administered (CumFe) - Period 2
Time frame: Urine sample collection from pre-dose to 72 hours post-dose
Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for AZD5462 and total radioactivity - Period 1
Time frame: Plasma sample collection from pre-dose to 168 hours post-dose
Time of maximum observed concentration (tmax) for AZD5462 and [14C]AZD5462 - Period 2
Time frame: Plasma sample collection from pre-dose to 72 hours post-dose
Maximum observed concentration (Cmax) for AZD5462 and [14C]AZD5462 - Period 2
Time frame: Plasma sample collection from pre-dose to 72 hours post-dose
Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for AZD5462 and [14C]AZD5462 - Period 2
Time frame: Plasma sample collection from pre-dose to 72 hours post-dose
Area under the curve from time 0 to the time of last measurable concentration (AUC0-t) for AZD5462 and [14C]AZD5462 - Period 2
Time frame: Plasma sample collection from pre-dose to 72 hours post-dose
Area under the curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUC0-extrap) for AZD5462 and [14C]AZD5462- Period 2
Time frame: Plasma sample collection from pre-dose to 72 hours post-dose
Terminal elimination half-life (t1/2) for AZD5462 and [14C]AZD5462 - Period 2
Time frame: Plasma sample collection from pre-dose to 72 hours post-dose
First order rate constant associated with the terminal (log-linear) portion of the curve (λz) for AZD5462 and [14C]AZD5462 - Period 2
Time frame: Plasma sample collection from pre-dose to 72 hours post-dose
Total body clearance calculated after a single IV administration (CL) for AZD5462 and [14C]AZD5462 - Period 2
Time frame: Plasma sample collection from pre-dose to 72 hours post-dose
Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F) for AZD5462 and [14C]AZD5462 - Period 2
Time frame: Plasma sample collection from pre-dose to 72 hours post-dose
Volume of distribution based on the terminal phase calculated using AUC(0-inf) after a single IV administration (Vz) for AZD5462 and [14C]AZD5462 - Period 2
Time frame: Plasma sample collection from pre-dose to 72 hours post-dose
Apparent volume of distribution at steady state after a single IV administration (Vss) for AZD5462 and [14C]AZD5462 - Period 2
Time frame: Plasma sample collection from pre-dose to 72 hours post-dose
Apparent volume of distribution based on the terminal phase calculated using AUC(0 inf) after a single extravascular administration where F (fraction of dose bioavailable) is unknown (Vz/F) for AZD5462 and [14C]AZD5462 - Period 2
Time frame: Plasma sample collection from pre-dose to 72 hours post-dose
Number of subjects with treatment-related adverse events - Periods 1 and 2
Time frame: Through study duration, an average of 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual participant-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Evans, MBChB, MRCS (Ed) principal investigator
Quotient Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD5462 film-coated tablet, [14C]AZD5462 Solution for Infusion and [14C]AZD5462 Oral Solution in people with Heart Failure, run by AstraZeneca at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of AZD5462 excreted (Ae) - Period 1 (time frame: Urine and faecal samples collected from pre-dose until 168 hours post-dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.