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NCT06157255Not yet recruiting

An ADME Study of [14C]AZD4604 and the Absolute Bioavailability of AZD4604

An Open-Label, Two-Part Sequential Study Designed to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD4604 and the Absolute Bioavailability of AZD4604 in Healthy Male and Female Subjects
AstraZenecaPhase 1ClinicalTrials.govdrug
Study focus
Disease/Condition
Asthma
Drug/Device/Intervention
AZD4604 Inhalation Powder, 1 mg
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
AstraZeneca
Location
Ruddington, United Kingdom
Timeline & enrollment
Phase
Phase 1
Start date
Feb 06, 2024
End date
Apr 19, 2024
Enrollment
8 participants
Primary outcome

Amount of AZD4604 excreted (Ae) - Part 1,Amount of AZD4604 excreted expressed as a fraction of dose excreted (Fe) - Part 1,The cumulative amount of AZD4604 excreted (CumAe) - Part 1,Cumulative amount of AZD4604 excreted expressed as a fraction of dose excreted (CumFe) - Part 1,Time to maximum concentration (tmax) for AZD4604 and total radioactivity - Part 1,Area under the curve from time 0 extrapolated to infinity for AZD4604 and total radioactivity (AUC-inf) - Part 1,Maximum observed concentration (Cmax) for AZD4604 and total radioactivity - Part 1,Area under the curve from time 0 to the time of the last measurable concentration for AZD4604 and total radioactivity (AUC0-t) - Part 1,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) and total radioactivity - Part 1,Terminal elimination half-life of AZD4604 (t1/2) and total radioactivity - Part 1,First order rate constant associated with the terminal (log-linear) portion of the curve for AZD4604 (λz) and total radioactivity - Part 1,Total body clearance calculated after a single IV administration (CL) - Part 1,Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F) - Part 1,Volume of distribution based on the terminal phase calculated using AUC(0-inf) after a single IV administration (Vz) - Part 1,Volume of distribution based on the terminal phase calculated using AUC(0-inf) after a single extravascular administration where F (fraction of dose bioavailable) is unknown (Vz/F) - Part 1,Assessment of metabolites in plasma, urine and faeces by liquid chromatography-radiochemical-detection and subsequent mass spectrometry - Part 1,Amount of AZD4604 excreted (Ae) - Part 2,Amount of AZD4604 excreted expressed as a fraction of dose excreted (Fe) - Part 2,The cumulative amount of AZD4604 excreted (CumAe) - Part 2,Cumulative amount of AZD4604 excreted expressed as a fraction of dose excreted (CumFe) - Part 2,Time to maximum concentration (tmax) for AZD4604 and total radioactivity - Part 2,Area under the curve from time 0 extrapolated to infinity for AZD4604 and total radioactivity (AUC-inf) - Part 2,Maximum observed concentration (Cmax) for AZD4604 and total radioactivity - Part 2,Area under the curve from time 0 to the time of the last measurable concentration for AZD4604 and total radioactivity (AUC0-t) - Part 2,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) and total radioactivity - Part 2,Terminal elimination half-life of AZD4604 (t1/2) and total radioactivity - Part 2,First order rate constant associated with the terminal (log-linear) portion of the curve for AZD4604 (λz) and total radioactivity - Part 2,Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F) - Part 2,Volume of distribution based on the terminal phase calculated using AUC(0-inf) after a single extravascular administration where F (fraction of dose bioavailable) is unknown (Vz/F) - Part 2,Renal clearance calculated using plasma AUC of AZD4604 and total radioactivity - Part 2,Assessment of metabolites in plasma, urine and faeces by liquid chromatography-radiochemical-detection and subsequent mass spectrometry - Part 2

Summary

The Sponsor is developing the test medicine, AZD4604, as a potential treatment for asthma.
 Asthma is a common lung condition caused by inflammation (swelling) of the breathing tubes
 that carry air in and out of the lungs, causing occasional breathing difficulties such as
 wheezing, shortness of breath, chest tightness and cough.
 
 This study in healthy volunteers will explore the following 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 gets into the bloodstream?
 
 - How does the body break down and get rid of the test medicine?
 
 This study will take place at one non-NHS site in Nottingham, and plans to enrol 8 healthy
 men and women aged 18-65 years who will be involved in both parts of the study.

ICD-10 classifications
AsthmaAsthma, unspecifiedNonallergic asthmaMixed asthmaPredominantly allergic asthma
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06157255
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06157255 through Pure Global AI's free database. This Phase 1 trial is sponsored by AstraZeneca and is currently Not yet recruiting. The study focuses on Asthma. Target enrollment is 8 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.