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

Phase 1Not Yet RecruitingNCT07812077

AstraZeneca16 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Participants

Interventions

[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

Eligibility

Sex: MALEMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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) Exclusion Criteria: * 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 * Current smokers or known or suspected history of alcohol or drug abuse * Excessive intake of caffeine-containing drinks or food

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

AstraZeneca Clinical Study Information Center

CONTACT

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

Data from ClinicalTrials.gov

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