Healthy ParticipantsPhase 1NCT07518459
A Study of Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]AZD4144
A Phase 1 study testing [14C]AZD4144 Solution for Infusion and [14C]AZD4144 Oral Solution in people with Healthy Participants, run by AstraZeneca at 1 site in United Kingdom.
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 radiolabeled 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 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- [14C]AZD4144 Solution for Infusion and [14C]AZD4144 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
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Feb 2026to 26 May 2026
- 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
- All sexes
- 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 32.0 kg/m2 inclusive
- Regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day)
Who cannot join
- History of any clinically important disease or disorder
- History or presence of clinically significant cardiovascular, renal, respiratory, gastrointestinal disease, or neurological or psychiatric disorder
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first dosing day
- Acute diarrhoea or constipation within 7 days of the first dosing day
- Participants who do not have suitable veins for multiple venepunctures/cannulation
- Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis
Show all 17Show fewer
- Any clinically significant abnormal findings in vital signs
- Any clinically significant abnormalities on 12-lead ECG
- Evidence of renal impairment
- Participants who have received any IMP in the last 90 days prior to the first dosing day
- Participants who have previously received AZD4144
- 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.
- Blood or plasma donation, or loss of more than 400 mL blood during the 3 months prior to the study.
- Use of any prescribed or non-prescribed medication including antacids, gastric pH modifying agents, analgesics, herbal remedies, vitamins and minerals within 2 weeks of the first dosing day
- Use of drugs or herbal medications with CYP3A4 enzyme-inducing properties such as St John's Wort or CYP3A4 inhibiting properties within 3 weeks of the first dosing day
- 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-Cohort Study of Absorption, Distribution, Metabolism, Excretion (ADME) of [14C]AZD4144 Following a Single Oral and IV Dose to 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 radiolabeled 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, and will enroll 2 groups of 8 healthy men 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 2 groups of 8 healthy men aged 30-65 years.
Each group will take part in 1 treatment period and receive a single dose of radiolabelled test medicine, either by injection into a vein or as a liquid by mouth. They'll stay in the clinic for up to 10 nights, attend 2 outpatient visits, 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]AZD4144 Solution for Infusion, [14C]AZD4144 Oral Solution
- Keywords
- Healthy participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]AZD4144 Solution for InfusionDrug
Also called AZD4144
Intravenous, fasted
[14C]AZD4144 Oral SolutionDrug
Also called AZD4144
Oral, fasted
| Study group | Role | What they receive |
|---|---|---|
| Regimen A | Experimental | Participants in Cohort 1 will receive a single intravenous injection of [14C]AZD4144 Solution for Infusion Receives: Drug: [14C]AZD4144 Solution for Infusion |
| Regimen B | Experimental | Participants in Cohort 2 will receive a single oral dose of [14C]AZD4144 Oral Solution Receives: Drug: [14C]AZD4144 Oral Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of AZD4144 excreted (Ae)
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C]AZD4144 in urine, faecal and all excreta
Measured: Urine and faecal samples collected from pre-dose until up to 216 hours post-dose
Amount of AZD4144 excreted expressed as a percentage of the radioactive dose administered (Fe)
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C]AZD4144 in urine, faeces and all excreta
Measured: Urine and faecal samples collected from pre-dose until up to 216 hours post-dose
Cumulative amount of AZD4144 excreted (CumAe)
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C]AZD4144 in urine, faecal and all excreta
Measured: Urine and faecal samples collected from pre-dose until up to 216 hours post-dose
Cumulative amount of AZD4144 excreted expressed as a percentage of the radioactive dose administered (CumFe)
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C]AZD4144 in urine, faecal and all excreta
Measured: Urine and faecal samples collected from pre-dose until up to 216 hours post-dose
Area under the curve (AUC) of circulating plasma total radioactivity (TR) accounting for 10% or more of the dose
Identification of the chemical structure of each metabolite accounting for more than 10% by AUC of circulating total radioactivity
Measured: Plasma, urine and faecal samples from pre-dose until up to 216 hours post-dose
80% or more of the radioactivity recovered in excreta
Identification of greater than 80% of the radioactivity recovered in the urine and/or faeces
Measured: Plasma, urine and faecal samples from pre-dose until up to 216 hours post-dose
Secondary outcomes (11)
Time of maximum observed concentration (tmax) for AZD4144 and total radioactivity
The PK of AZD4144 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 168 hours post-dose
Maximum observed concentration (Cmax) for AZD4144 and total radioactivity
The PK of AZD4144 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 168 hours post-dose
Area under the curve from time 0 to the time of last measurable concentration (AUC0-t) for AZD4144 and total radioactivity
The PK of AZD4144 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 168 hours post-dose
Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for AZD4144 and total radioactivity
The PK of AZD4144 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 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 (AUCextrap) for AZD4144 and total radioactivity
The PK of AZD4144 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 168 hours post-dose
Terminal elimination half-life (T1/2) for AZD4144 and total radioactivity
The PK of AZD4144 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 168 hours post-dose
Apparent volume of distribution at steady state after a single IV administration (Vss) for AZD4144 and total radioactivity
The PK of AZD4144 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 168 hours post-dose
Total body clearance calculated after a single IV administration (CL) for AZD4144 and total radioactivity
The PK of AZD4144 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 168 hours post-dose
Renal clearance calculated using plasma AUC (CLR) for AZD4144 and total radioactivity
The PK of AZD4144 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 168 hours post-dose
Whole blood:plasma concentration ratios
Whole blood:plasma concentration ratios for total radioactivity
Measured: Whole blood and plasma samples collected from pre-dose until 168 hours post-dose
Absolute bioavailability
Absolute bioavailability (F) of AZD4144 based on AUC0-inf
Measured: Plasma samples collected from pre-dose until 168 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 posted8 Apr 2026
- Study start11 Feb 2026
- Primary completion26 May 2026
- Study completion26 May 2026
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
- Cohorts 1 and 2 are each single arm regimens
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Responsible party
- Sponsor
- Investigators
- Sharan Sidhu, MBChB, BAO, Principal investigator, Quotient Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518459
- Sponsor's protocol ID
- D9440C00005
- Status last verified
- Jun 2026
- First submitted
- 10 Feb 2026
- Last updated
- 22 Jun 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 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 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Two-Cohort Study of Absorption, Distribution, Metabolism, Excretion (ADME) of [14C]AZD4144 Following a Single Oral and IV Dose to Healthy Male Participants
- ClinicalTrials.gov ID
- NCT07518459
- Acronym / sponsor ID
- D9440C00005
- Conditions
- Healthy Participants
- Keywords
- Healthy participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- 26 May 2026 (actual)
- Study completion
- 26 May 2026 (actual)
- First posted
- 8 Apr 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 radiolabeled 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, and will enroll 2 groups of 8 healthy men 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 2 groups of 8 healthy men aged 30-65 years.
Each group will take part in 1 treatment period and receive a single dose of radiolabelled test medicine, either by injection into a vein or as a liquid by mouth. They'll stay in the clinic for up to 10 nights, attend 2 outpatient visits, 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
- Cohorts 1 and 2 are each single arm regimens
| Arm | Type | Receives |
|---|---|---|
| Regimen A | Experimental | Drug: [14C]AZD4144 Solution for InfusionParticipants in Cohort 1 will receive a single intravenous injection of [14C]AZD4144 Solution for Infusion |
| Regimen B | Experimental | Drug: [14C]AZD4144 Oral SolutionParticipants in Cohort 2 will receive a single oral dose of [14C]AZD4144 Oral Solution |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- 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 32.0 kg/m2 inclusive
- Regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day)
Key exclusion criteria (17 listed)
- History of any clinically important disease or disorder
- History or presence of clinically significant cardiovascular, renal, respiratory, gastrointestinal disease, or neurological or psychiatric disorder
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first dosing day
- Acute diarrhoea or constipation within 7 days of the first dosing day
- 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 |
|---|---|---|
| [14C]AZD4144 Solution for InfusionAlso: AZD4144Intravenous, fasted | Drug | Regimen A |
| [14C]AZD4144 Oral SolutionAlso: AZD4144Oral, fasted | Drug | Regimen B |
Primary outcome
Amount of AZD4144 excreted (Ae)
Time frame: Urine and faecal samples collected from pre-dose until up to 216 hours post-dose
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C]AZD4144 in urine, faecal and all excreta
Amount of AZD4144 excreted expressed as a percentage of the radioactive dose administered (Fe)
Time frame: Urine and faecal samples collected from pre-dose until up to 216 hours post-dose
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C]AZD4144 in urine, faeces and all excreta
Cumulative amount of AZD4144 excreted (CumAe)
Time frame: Urine and faecal samples collected from pre-dose until up to 216 hours post-dose
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C]AZD4144 in urine, faecal and all excreta
Cumulative amount of AZD4144 excreted expressed as a percentage of the radioactive dose administered (CumFe)
Time frame: Urine and faecal samples collected from pre-dose until up to 216 hours post-dose
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C]AZD4144 in urine, faecal and all excreta
Area under the curve (AUC) of circulating plasma total radioactivity (TR) accounting for 10% or more of the dose
Time frame: Plasma, urine and faecal samples from pre-dose until up to 216 hours post-dose
Identification of the chemical structure of each metabolite accounting for more than 10% by AUC of circulating total radioactivity
80% or more of the radioactivity recovered in excreta
Time frame: Plasma, urine and faecal samples from pre-dose until up to 216 hours post-dose
Identification of greater than 80% of the radioactivity recovered in the urine and/or faeces
11 secondary outcomes
Time of maximum observed concentration (tmax) for AZD4144 and total radioactivity
Time frame: Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose
Maximum observed concentration (Cmax) for AZD4144 and total radioactivity
Time frame: Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose
Area under the curve from time 0 to the time of last measurable concentration (AUC0-t) for AZD4144 and total radioactivity
Time frame: Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose
Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for AZD4144 and total radioactivity
Time frame: Plasma, urine and whole blood samples collected from pre-dose until up 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 (AUCextrap) for AZD4144 and total radioactivity
Time frame: Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose
Terminal elimination half-life (T1/2) for AZD4144 and total radioactivity
Time frame: Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose
Apparent volume of distribution at steady state after a single IV administration (Vss) for AZD4144 and total radioactivity
Time frame: Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose
Total body clearance calculated after a single IV administration (CL) for AZD4144 and total radioactivity
Time frame: Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose
Renal clearance calculated using plasma AUC (CLR) for AZD4144 and total radioactivity
Time frame: Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose
Whole blood:plasma concentration ratios
Time frame: Whole blood and plasma samples collected from pre-dose until 168 hours post-dose
Absolute bioavailability
Time frame: Plasma samples collected from pre-dose until 168 hours post-dose
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 22 Jun 2026.
- 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.
Sharan Sidhu, MBChB, BAO 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 [14C]AZD4144 Solution for Infusion and [14C]AZD4144 Oral Solution in people with Healthy Participants, 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 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: finished, as of the sponsor's last update on 22 Jun 2026. 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 AZD4144 excreted (Ae) (time frame: Urine and faecal samples collected from pre-dose until up to 216 hours post-dose). The study lists 6 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 22 Jun 2026.