Healthy ParticipantsPhase 1NCT07812077
A Study Designed to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD4954 and the Absolute Bioavailability of AZD4954
A Phase 1 study testing [14C]AZD4954 Oral Solution, AZD4954 film-coated tablet and [14C]AZD4954 Solution for Infusion in people with Healthy Participants, run by AstraZeneca.
Trial summary
This study in healthy volunteers aims to explore blood levels and side effects of the test medicine, and look at how it is broken down when injected into a vein or given as a liquid by mouth. The test medicine will be radiolabelled with a small amount of carbon-14 so it can be tracked 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
- Healthy Participants
- What is being tested?
- [14C]AZD4954 Oral Solution, AZD4954 film-coated tablet and [14C]AZD4954 Solution for Infusion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 19 Oct 2026to 17 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 of 18.0 to 35.0 kg/m2 inclusive
- Regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day)
Who cannot join
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- Presence or history of clinically significant allergy requiring treatment
- History of clinically significant cardiovascular, renal, hepatic, respiratory, dermatological or gastrointestinal disease, and neurological or psychiatric disorder
- History of cholecystectomy or gall stones
- History of GI surgery
- Acute diarrhoea or constipation in the 7 days before the predicted Day 1
Show all 17Show fewer
- Participants who do not have suitable veins for multiple venepunctures/cannulation
- Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis
- Evidence of renal impairment at screening
- Participants who have received any IMP in a clinical research study within the 90 days prior to Day 1
- Participants who have previously been administered IMP in this study
- Radiation exposure exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years
- Participants who have been administered IMP in an ADME study in the last 12 months
- Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
- Use of any prescribed or non-prescribed medication including antacids, gastric pH modifying agents, analgesics, herbal remedies, vitamins and minerals within 2 weeks of dosing
- Current smokers or known or suspected history of alcohol or drug abuse
- Excessive intake of caffeine-containing drinks or food
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
About this study
Official title: An Open-Label Study to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD4954 and Absolute Bioavailability of AZD4954 in Healthy Male Participants
This study in healthy volunteers aims to explore blood levels and side effects of the test medicine, and look at how it is broken down when injected into a vein or given as a liquid by mouth. The test medicine will be radiolabelled with a small amount of carbon-14 so it can be tracked in the body.
This two-part study will take place at one site in Nottingham, United Kingdom, and will enroll 8 healthy men in each part, aged 30-65 years.
Read the detailed description
This study in healthy volunteers aims to explore blood levels and side effects of the test medicine, and look at how it is broken down when injected into a vein or given as a liquid by mouth. The test medicine will be radiolabelled with a small amount of carbon-14 so it can be tracked in the body.
This study will take place at one site in Nottingham, United Kingdom.
It is planned to enroll 8 healthy male participants in each part, aged 30-65 years.
In part 1 volunteers will receive a single dose of radiolabelled test medicine as a liquid by mouth. They'll stay in the clinic for up to 24 nights, attend 1 outpatient visit, and take up to 8 weeks to finish the study.
In part 2 volunteers will receive a single dose of test medicine by mouth and, shortly afterwards, a very tiny dose of radiolabelled study medicine by injection into a vein. They'll stay in the clinic for up to 15 nights, attend 1 outpatient visit, and take up to 7 weeks to finish the study.
Blood and urine samples will be collected to do safety tests. Blood, urine and faecal samples will be collected to measure the amount of test medicine and its breakdown products.
- Conditions
- Healthy Participants
- Being tested
- [14C]AZD4954 Oral Solution, AZD4954 film-coated tablet, [14C]AZD4954 Solution for Infusion
- Keywords
- Healthy participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]AZD4954 Oral SolutionDrug
Participants in Part 1 will recieve a single dose of [14C]AZD4954 oral solution
AZD4954 film-coated tabletDrug
Participants in Part 2 will receive a single dose of AZD4954 film-coated tablet by mouth
[14C]AZD4954 Solution for InfusionDrug
Participants in Part 2 will receive a single very tiny dose of radiolabelled [14C]AZD4954 Solution for Infusion as a slow injection into a vein
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Participants in Part 1 will receive a single dose of [14C]AZD4954 Oral Solution. Receives: Drug: [14C]AZD4954 Oral Solution |
| Part 2 | Experimental | Participants in Part 2 will receive a single unlabelled oral dose of AZD4954 tablet and a radiolabelled IV microtracer dose of [14C]AZD4954. Receives: Drug: AZD4954 film-coated tablet; Drug: [14C]AZD4954 Solution for Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of AZD4954 excreted (Ae) (Part 1)
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C] AZD4954 in urine, faeces and all excreta
Measured: Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
Amount of AZD4954 excreted expressed as a fraction of dose excreted (Fe) (Part 1)
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C] AZD4954 in urine, faeces and all excreta
Measured: Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
Cumulative amount of AZD4954 excreted (CumAe) (Part 1)
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C] AZD4954 in urine, faeces and all excreta
Measured: Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
Cumulative amount of AZD4954 excreted expressed as a fraction of dose excreted (CumFe) (Part 1)
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C] AZD4954 in urine, faeces and all excreta
Measured: Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
Absolute bioavailability (F) based on AUC0-inf (Part 2)
Absolute bioavailability of AZD4954 oral and IV administration, adjusted for dose
Measured: Plasma, urine and faecal samples from pre-dose until up to 336 hours post-dose
Secondary outcomes (7)
Maximum observed concentration (Cmax) for AZD4954 and total radioactivity (Parts 1 and 2)
The PK of AZD4954 and [14C]AZD4954 in plasma and urine, and total radioactivity in plasma and whole blood
Measured: Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
Time of maximum observed concentration (Tmax) for AZD4954 and total radioactivity (Parts 1 and 2)
The PK of AZD4954 and [14C]AZD4954 in plasma and urine, and total radioactivity in plasma and whole blood
Measured: Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for AZD4954 and total radioactivity (Parts 1 and 2)
The PK of AZD4954 and [14C]AZD4954 in plasma and urine, and total radioactivity in plasma and whole blood
Measured: Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
Terminal elimination half-life (T1/2) for AZD4954 and total radioactivity (Parts 1 and 2)
The PK of AZD4954 and [14C]AZD4954 in plasma and urine, and total radioactivity in plasma and whole blood
Measured: Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
Area under the curve (AUC) of circulating total radioactivity accounting for 10% or more of the dose (Part 1)
Identification of the chemical structure of each metabolite
Measured: Plasma, urine and faecal samples collected from pre-dose until up to 552 hours post-dose
80% or more of the radioactivity recovered in excreta (Part 1)
Identification of the chemical structure of each metabolite
Measured: Plasma, urine and faecal samples collected from pre-dose until up to 552 hours post-dose
Disposition of total radioactivity in plasma and in blood (Part 1)
Evaluation of whole blood:plasma concentration ratios for total radioactivity
Measured: Plasma, and whole blood samples collected from pre-dose until up to 552 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start19 Oct 2026 (estimated)
- Primary completion17 Dec 2026 (estimated)
- Study completion17 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parts 1 and 2 are each single arm regimens
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Responsible party
- Sponsor
- Investigators
- Sharan Sidhu, MBChB, BAO, MRCS, MFPM, Principal investigator, Quotient Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812077
- Sponsor's protocol ID
- D7300C00005
- Status last verified
- Aug 2026
- First submitted
- 4 Sep 2026
- Last updated
- 10 Sep 2026
- 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 patient-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 shared.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD4954 and Absolute Bioavailability of AZD4954 in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT07812077
- Acronym / sponsor ID
- D7300C00005
- Conditions
- Healthy Participants
- Keywords
- Healthy participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Study start
- 19 Oct 2026 (estimated)
- Primary completion
- 17 Dec 2026 (estimated)
- Study completion
- 17 Dec 2026 (estimated)
- First posted
- 10 Sep 2026 (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.
This study in healthy volunteers aims to explore blood levels and side effects of the test medicine, and look at how it is broken down when injected into a vein or given as a liquid by mouth. The test medicine will be radiolabelled with a small amount of carbon-14 so it can be tracked in the body.
This two-part study will take place at one site in Nottingham, United Kingdom, and will enroll 8 healthy men in each part, aged 30-65 years.
Detailed description
This study in healthy volunteers aims to explore blood levels and side effects of the test medicine, and look at how it is broken down when injected into a vein or given as a liquid by mouth. The test medicine will be radiolabelled with a small amount of carbon-14 so it can be tracked in the body.
This study will take place at one site in Nottingham, United Kingdom.
It is planned to enroll 8 healthy male participants in each part, aged 30-65 years.
In part 1 volunteers will receive a single dose of radiolabelled test medicine as a liquid by mouth. They'll stay in the clinic for up to 24 nights, attend 1 outpatient visit, and take up to 8 weeks to finish the study.
In part 2 volunteers will receive a single dose of test medicine by mouth and, shortly afterwards, a very tiny dose of radiolabelled study medicine by injection into a vein. They'll stay in the clinic for up to 15 nights, attend 1 outpatient visit, and take up to 7 weeks to finish the study.
Blood and urine samples will be collected to do safety tests. Blood, urine and faecal samples will be collected to measure the amount of test medicine and its breakdown products.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parts 1 and 2 are each single arm regimens
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: [14C]AZD4954 Oral SolutionParticipants in Part 1 will receive a single dose of [14C]AZD4954 Oral Solution. |
| Part 2 | Experimental | Drug: AZD4954 film-coated tablet, Drug: [14C]AZD4954 Solution for InfusionParticipants in Part 2 will receive a single unlabelled oral dose of AZD4954 tablet and a radiolabelled IV microtracer dose of [14C]AZD4954. |
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 of 18.0 to 35.0 kg/m2 inclusive
- Regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day)
Key exclusion criteria (17 listed)
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- Presence or history of clinically significant allergy requiring treatment
- History of clinically significant cardiovascular, renal, hepatic, respiratory, dermatological or gastrointestinal disease, and neurological or psychiatric disorder
- History of cholecystectomy or gall stones
- History of GI surgery
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 |
|---|---|---|
| [14C]AZD4954 Oral SolutionParticipants in Part 1 will recieve a single dose of [14C]AZD4954 oral solution | Drug | Part 1 |
| AZD4954 film-coated tabletParticipants in Part 2 will receive a single dose of AZD4954 film-coated tablet by mouth | Drug | Part 2 |
| [14C]AZD4954 Solution for InfusionParticipants in Part 2 will receive a single very tiny dose of radiolabelled [14C]AZD4954 Solution for Infusion as a slow injection into a vein | Drug | Part 2 |
Primary outcome
Amount of AZD4954 excreted (Ae) (Part 1)
Time frame: Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C] AZD4954 in urine, faeces and all excreta
Amount of AZD4954 excreted expressed as a fraction of dose excreted (Fe) (Part 1)
Time frame: Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C] AZD4954 in urine, faeces and all excreta
Cumulative amount of AZD4954 excreted (CumAe) (Part 1)
Time frame: Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C] AZD4954 in urine, faeces and all excreta
Cumulative amount of AZD4954 excreted expressed as a fraction of dose excreted (CumFe) (Part 1)
Time frame: Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C] AZD4954 in urine, faeces and all excreta
Absolute bioavailability (F) based on AUC0-inf (Part 2)
Time frame: Plasma, urine and faecal samples from pre-dose until up to 336 hours post-dose
Absolute bioavailability of AZD4954 oral and IV administration, adjusted for dose
7 secondary outcomes
Maximum observed concentration (Cmax) for AZD4954 and total radioactivity (Parts 1 and 2)
Time frame: Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
Time of maximum observed concentration (Tmax) for AZD4954 and total radioactivity (Parts 1 and 2)
Time frame: Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for AZD4954 and total radioactivity (Parts 1 and 2)
Time frame: Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
Terminal elimination half-life (T1/2) for AZD4954 and total radioactivity (Parts 1 and 2)
Time frame: Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
Area under the curve (AUC) of circulating total radioactivity accounting for 10% or more of the dose (Part 1)
Time frame: Plasma, urine and faecal samples collected from pre-dose until up to 552 hours post-dose
80% or more of the radioactivity recovered in excreta (Part 1)
Time frame: Plasma, urine and faecal samples collected from pre-dose until up to 552 hours post-dose
Disposition of total radioactivity in plasma and in blood (Part 1)
Time frame: Plasma, and whole blood samples collected from pre-dose until up to 552 hours post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-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 shared.
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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.
AstraZeneca Clinical Study Information Center contact
Sharan Sidhu, MBChB, BAO, MRCS, MFPM principal investigator
Quotient Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]AZD4954 Oral Solution, AZD4954 film-coated tablet and [14C]AZD4954 Solution for Infusion in people with Healthy Participants, run by AstraZeneca.
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 17 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: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of AZD4954 excreted (Ae) (Part 1) (time frame: Urine and faecal samples collected from pre-dose until up to 552 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 10 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.