A Phase 1 interventional study of [14C]AZD4954 Oral Solution and AZD4954 film-coated tablet in Healthy Participants, sponsored by AstraZeneca. Recruiting at 1 site in United Kingdom. Open to male participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
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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.
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.
AstraZeneca is the lead sponsor of 3,503 studies on the registry; 273 are open to participants now.
Of its 369 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in Part 1 will receive a single dose of \[14C\]AZD4954 Oral Solution.
Drug: [14C]AZD4954 Oral Solution
Participants in Part 2 will receive a single unlabelled oral dose of AZD4954 tablet and a radiolabelled IV microtracer dose of \[14C\]AZD4954.
Drug: AZD4954 film-coated tablet · Drug: [14C]AZD4954 Solution for Infusion
Participants in Part 1 will recieve a single dose of \[14C\]AZD4954 oral solution
Participants in Part 2 will receive a single dose of AZD4954 film-coated tablet by mouth
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
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Plasma, urine and faecal samples from pre-dose until up to 336 hours post-dose
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
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)
The PK of AZD4954 and \[14C\]AZD4954 in plasma and urine, and total radioactivity in plasma and whole blood
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)
The PK of AZD4954 and \[14C\]AZD4954 in plasma and urine, and total radioactivity in plasma and whole blood
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)
The PK of AZD4954 and \[14C\]AZD4954 in plasma and urine, and total radioactivity in plasma and whole blood
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)
Identification of the chemical structure of each metabolite
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)
Identification of the chemical structure of each metabolite
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)
Evaluation of whole blood:plasma concentration ratios for total radioactivity
Time frame: Plasma, and whole blood samples collected from pre-dose until up to 552 hours post-dose
Plan to share: 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.
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment athttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environmentVivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Mar 2027, 4 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 13, 2026: primary completion Dec 2026 → Mar 2027 and completion Dec 2026 → Mar 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: AZD4954