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

Study identifier:D8210C00004

ClinicalTrials.gov identifier:NCT06157255

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

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

Medical condition

asthma

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD4604 Inhalation Powder, 1 mg, [14C]AZD4604 Solution for Infusion 6 μg/mL (NMT 37.0 kBq/5 mL), [14C]AZD4604 Oral Solution, 4 mg (NMT 37.0 kBq)

Sex

All

Estimated Enrollment

8

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 16 Feb 2024
Estimated Primary Completion Date: 19 Apr 2024
Estimated Study Completion Date: 19 Apr 2024

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Quotient Sciences Limited

Inclusion and exclusion criteria