A Study Designed to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD4954 and the Absolute Bioavailability of AZD4954

NCT07812077 | Not Yet Recruiting Phase 1

• 1 other identifier: D7300C00005
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Healthy Participants

Keywords

Healthy participants

Outcome Measures

Primary Outcomes (5)

• 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

  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

  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

  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

  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

  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)

  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)

  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)

  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)

  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)

  Plasma, urine and faecal samples collected from pre-dose until up to 552 hours post-dose

Study Arms (2)

Part 1

EXPERIMENTAL

Participants in Part 1 will receive a single dose of \[14C\]AZD4954 Oral Solution.

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.

Drug: AZD4954 film-coated tablet; Drug: [14C]AZD4954 Solution for Infusion

Interventions

[14C]AZD4954 Solution for Infusion DRUG

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

Part 2

[14C]AZD4954 Oral Solution DRUG

Participants in Part 1 will recieve a single dose of \[14C\]AZD4954 oral solution

Part 1

AZD4954 film-coated tablet DRUG

Participants in Part 2 will receive a single dose of AZD4954 film-coated tablet by mouth

Part 2

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• AstraZeneca: lead
• Quotient Sciences: collaborator

Study Officials

• Sharan Sidhu, MBChB, BAO, MRCS, MFPM

  Quotient Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parts 1 and 2 are each single arm regimens

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 10, 2026
• Study Start (Estimated): October 19, 2026
• Primary Completion (Estimated): December 17, 2026
• Study Completion (Estimated): December 17, 2026
• Last Updated: September 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• 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.