Healthy ParticipantsPhase 1NCT06857695
A Study to Assess the Mass Balance and ADME of [14C]AZD5004 and the Absolute Bioavailability of AZD5004
A Phase 1 study testing AZD5004 film-coated tablet, [14C]AZD5004 Solution for Infusion and [14C]AZD5004 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 answer these questions: Does the test medicine cause any important side effects? What are the blood levels of the test medicine and how quickly does the body get rid of it? How much of the test medicine taken by mouth gets into the bloodstream? How does the body break down and… 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?
- AZD5004 film-coated tablet, [14C]AZD5004 Solution for Infusion and [14C]AZD5004 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
- 6 Mar 2025to 5 May 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 - 35.0 kg/m2 and body weight ≥63 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
- Excessive intake of caffeine containing drinks or food
- History/family history of medullary thyroid carcinoma or multiple endocrine neoplasia
- Uncontrolled thyroid disease
Show all 17Show fewer
- History of acute pancreatitis or gallstones
- Serum triglyceride concentrations > 1000 mg/dL (11 mmol/L)
- Any history of significant inflammatory bowel disease, gastroparesis, or other severe disease or prior surgery affecting the upper GI tract
- Participants who do not have suitable veins for multiple venepunctures/cannulation
- Clinically significant abnormal clinical chemistry, haematology or urinalysis
- Significant hepatic disease
- Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG and any clinically important abnormalities in the 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 [14C] ADME study in the last 12 months.
- Use of any prescribed or non-prescribed medication
- Current smokers or known or suspected history of alcohol or drug abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Study to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD5004 and Absolute Bioavailability of AZD5004 in Healthy Male Participants
This study in healthy volunteers aims to answer these questions:
- Does the test medicine cause any important side effects?
- What are the blood levels of the test medicine and how quickly does the body get rid of it?
- How much of the test medicine taken by mouth gets into the bloodstream?
- How does the body break down and get rid of the test medicine?
This study will take place at one site in Nottingham, United Kingdom, and plans to enrol 8 healthy men aged 30-65 years, who will be involved in both parts of the study.
Read the detailed description
In this 2-part study, healthy volunteers will be given three doses of test medicine to find out how the body breaks down and gets rid of the test medicine. Two doses will be 'radiolabelled' - they will contain a small amount of radioactivity (Carbon-14) so that it can be tracked in the body. The amount of radiactivity is less than 6 days of the average radiation exposure received in the UK each year, and slightly less than the radiation dose that would result from a single head x-ray or two leg x-rays.
This study in healthy volunteers aims to answer these questions:
- Does the test medicine cause any important side effects?
- What are the blood levels of the test medicine and how quickly does the body get rid of it?
- How much of the test medicine taken by mouth gets into the bloodstream?
- How does the body break down and get rid of the test medicine?
This study will take place at one site in Nottingham, United Kingdom.
It plans to enrol 8 healthy men aged 30-65 years, who will be involved in both parts of the study.
In Part 1, volunteers will receive a single dose of the test medicine by mouth and, on the same day, a very tiny dose of radiolabelled study medicine by injection into a vein. After a minimum of 7 days, in Part 2, volunteers will receive a dose of test medicine containing a very tiny amount of radio label, by mouth. They'll stay in the clinic for up to 6 nights in Part 1 and 8 nights in Part 2 and take up to 7 weeks to finish the study.
We'll collect blood and urine samples to do safety tests. Over a period of at least 15 days, we'll take many blood samples. In Part 2 volunteers will collect all their urine and faeces so that we can measure the amount of test medicine and its breakdown products.
- Conditions
- Healthy Participants
- Being tested
- AZD5004 film-coated tablet, [14C]AZD5004 Solution for Infusion, [14C]AZD5004 Oral Solution
- Keywords
- Healthy Participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5004 film-coated tabletDrug
Also called AZD5004
oral, fasted
[14C]AZD5004 Solution for InfusionDrug
Also called [14C]AZD5004
intravenous, fasted
[14C]AZD5004 Oral SolutionDrug
Also called [14C]AZD5004
oral, fasted
| Study group | Role | What they receive |
|---|---|---|
| AZD5004 | Experimental | A single dose of AZD5004 film-coated tablet and a single dose of [14C]AZD5004 Solution for Infusion (Part 1)
A single dose of [14C]AZD5004 Oral Solution (Part 2) Receives: Drug: AZD5004 film-coated tablet; Drug: [14C]AZD5004 Solution for Infusion; Drug: [14C]AZD5004 Oral Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute bioavailability - Part 1
Absolute bioavailability (F) based on AUC0-inf of oral and IV administration, adjusted for dose
Measured: Plasma sample collection from pre-dose to 110 hrs post-dose
Amount of AZD5004 excreted (Ae) - Part 2
Mass balance recovery of total radioactivity (TR) in urine, faeces and all excreta (urine and faeces combined)
Measured: Urine and faecal samples collected from pre-dose until 168 hours post-dose
Amount of AZD5004 excreted expressed as a percentage of the dose administered (Fe) - Part 2
Mass balance recovery of total radioactivity (TR) in urine, faeces and all excreta (urine and faeces combined)
Measured: Urine and faecal samples collected from pre-dose until 168 hours post dose
Cumulative amount of AZD5004 excreted (CumAe) - Part 2
Mass balance recovery of total radioactivity (TR) in urine, faeces and all excreta (urine and faeces combined)
Measured: Urine and faecal samples collected from pre-dose until 168 hours post dose
Cumulative amount of AZD5004 excreted expressed as a percentage of the dose administered (CumFe) - Part 2
Mass balance recovery of total radioactivity (TR) in urine, faeces and all excreta (urine and faeces combined)
Measured: Urine and faecal samples collected from pre-dose until 168 hours post dose
Secondary outcomes (5)
Maximum observed concentration (Cmax) for AZD5004 and total radioactivity (TR) - Part 1 and Part 2
Pharmacokinetics (PK) ofAZD5004 and [14C]AZD5004 in plasma
Measured: Plasma sample collection from pre-dose to 110 hours post-dose in Part 1 and from pre-dose to 168 hours post-dose in Part 2
Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for AZD5004 - Part 1 and Part 2
Pharmacokinetics (PK) of AZD5004 and [14C]AZD5004 in plasma
Measured: Plasma sample collection from pre-dose to 110 hours post-dose in Part 1 and from pre-dose to 168 hours post-dose in Part 2
Area under the curve (AUC) of circulating plasma total radioactivity (TR) or accounting for 10% or more of the dose in excreta - Part 2
Identification of the chemical structure of each metabolite accounting for more than 10% by AUC of circulating total radioactivity (TR) or accounting for 10% or more of the dose in excreta
Measured: Plasma, urine and faecal samples from pre-dose until 168 hours post-dose
Blood:plasma concentration ratios - Part 2
Blood:plasma concentration ratios for total radioactivity (TR)
Measured: Whole blood and plasma samples collected from pre-dose until 168 hoours post-dose
Number of subjects with treatment-related adverse events - Part 1 and 2
To provide additional safety and tolerability information for AZD5004 by assessing the incidence of AEs
Measured: Through study duration, approximately 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start6 Mar 2025
- Primary completion5 May 2025
- Study completion5 May 2025
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
- 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
- Sharan Sidhu, MBChB, BAO, MRCS, MFPM, Principal investigator, Quotient Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857695
- Sponsor's protocol ID
- D7260C00010
- Status last verified
- May 2025
- First submitted
- 27 Feb 2025
- Last updated
- 28 May 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 28 May 2025. 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]AZD5004 and Absolute Bioavailability of AZD5004 in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT06857695
- Acronym / sponsor ID
- D7260C00010
- Conditions
- Healthy Participants
- Keywords
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 4 Mar 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.
This study in healthy volunteers aims to answer these questions:
- Does the test medicine cause any important side effects?
- What are the blood levels of the test medicine and how quickly does the body get rid of it?
- How much of the test medicine taken by mouth gets into the bloodstream?
- How does the body break down and get rid of the test medicine?
This study will take place at one site in Nottingham, United Kingdom, and plans to enrol 8 healthy men aged 30-65 years, who will be involved in both parts of the study.
Detailed description
In this 2-part study, healthy volunteers will be given three doses of test medicine to find out how the body breaks down and gets rid of the test medicine. Two doses will be 'radiolabelled' - they will contain a small amount of radioactivity (Carbon-14) so that it can be tracked in the body. The amount of radiactivity is less than 6 days of the average radiation exposure received in the UK each year, and slightly less than the radiation dose that would result from a single head x-ray or two leg x-rays.
This study in healthy volunteers aims to answer these questions:
- Does the test medicine cause any important side effects?
- What are the blood levels of the test medicine and how quickly does the body get rid of it?
- How much of the test medicine taken by mouth gets into the bloodstream?
- How does the body break down and get rid of the test medicine?
This study will take place at one site in Nottingham, United Kingdom.
It plans to enrol 8 healthy men aged 30-65 years, who will be involved in both parts of the study.
In Part 1, volunteers will receive a single dose of the test medicine by mouth and, on the same day, a very tiny dose of radiolabelled study medicine by injection into a vein. After a minimum of 7 days, in Part 2, volunteers will receive a dose of test medicine containing a very tiny amount of radio label, by mouth. They'll stay in the clinic for up to 6 nights in Part 1 and 8 nights in Part 2 and take up to 7 weeks to finish the study.
We'll collect blood and urine samples to do safety tests. Over a period of at least 15 days, we'll take many blood samples. In Part 2 volunteers will collect all their urine and faeces so that we can measure the amount of test medicine and its breakdown products.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZD5004 | Experimental | Drug: AZD5004 film-coated tablet, Drug: [14C]AZD5004 Solution for Infusion, Drug: [14C]AZD5004 Oral SolutionA single dose of AZD5004 film-coated tablet and a single dose of [14C]AZD5004 Solution for Infusion (Part 1) A single dose of [14C]AZD5004 Oral Solution (Part 2) |
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 - 35.0 kg/m2 and body weight ≥63 kg
- Regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day)
Key exclusion criteria (17 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
- Excessive intake of caffeine containing drinks or food
- History/family history of medullary thyroid carcinoma or multiple endocrine neoplasia
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 |
|---|---|---|
| AZD5004 film-coated tabletAlso: AZD5004oral, fasted | Drug | AZD5004 |
| [14C]AZD5004 Solution for InfusionAlso: [14C]AZD5004intravenous, fasted | Drug | AZD5004 |
| [14C]AZD5004 Oral SolutionAlso: [14C]AZD5004oral, fasted | Drug | AZD5004 |
Primary outcome
Absolute bioavailability - Part 1
Time frame: Plasma sample collection from pre-dose to 110 hrs post-dose
Absolute bioavailability (F) based on AUC0-inf of oral and IV administration, adjusted for dose
Amount of AZD5004 excreted (Ae) - Part 2
Time frame: Urine and faecal samples collected from pre-dose until 168 hours post-dose
Mass balance recovery of total radioactivity (TR) in urine, faeces and all excreta (urine and faeces combined)
Amount of AZD5004 excreted expressed as a percentage of the dose administered (Fe) - Part 2
Time frame: Urine and faecal samples collected from pre-dose until 168 hours post dose
Mass balance recovery of total radioactivity (TR) in urine, faeces and all excreta (urine and faeces combined)
Cumulative amount of AZD5004 excreted (CumAe) - Part 2
Time frame: Urine and faecal samples collected from pre-dose until 168 hours post dose
Mass balance recovery of total radioactivity (TR) in urine, faeces and all excreta (urine and faeces combined)
Cumulative amount of AZD5004 excreted expressed as a percentage of the dose administered (CumFe) - Part 2
Time frame: Urine and faecal samples collected from pre-dose until 168 hours post dose
Mass balance recovery of total radioactivity (TR) in urine, faeces and all excreta (urine and faeces combined)
5 secondary outcomes
Maximum observed concentration (Cmax) for AZD5004 and total radioactivity (TR) - Part 1 and Part 2
Time frame: Plasma sample collection from pre-dose to 110 hours post-dose in Part 1 and from pre-dose to 168 hours post-dose in Part 2
Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for AZD5004 - Part 1 and Part 2
Time frame: Plasma sample collection from pre-dose to 110 hours post-dose in Part 1 and from pre-dose to 168 hours post-dose in Part 2
Area under the curve (AUC) of circulating plasma total radioactivity (TR) or accounting for 10% or more of the dose in excreta - Part 2
Time frame: Plasma, urine and faecal samples from pre-dose until 168 hours post-dose
Blood:plasma concentration ratios - Part 2
Time frame: Whole blood and plasma samples collected from pre-dose until 168 hoours post-dose
Number of subjects with treatment-related adverse events - Part 1 and 2
Time frame: Through study duration, approximately 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 28 May 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.
Sharan Sidhu, MBChB, BAO, MRCS, MFPM 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 AZD5004 film-coated tablet, [14C]AZD5004 Solution for Infusion and [14C]AZD5004 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 28 May 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?
Absolute bioavailability - Part 1 (time frame: Plasma sample collection from pre-dose to 110 hrs 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 28 May 2025.