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

NCT06157255 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-05-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

AZD4604 Inhalation Powder, 1 mg

3 mg dose, inhaled, fasted

DRUG

[14C]AZD4604 Solution for Infusion 6 μg/mL (NMT 37.0 kBq/5 mL)

30 μg, intravenous, fasted

DRUG

[14C]AZD4604 Oral Solution, 4 mg (NMT 37.0 kBq)

4 mg, oral, fasted

Sponsors & Collaborators

  • Quotient Sciences

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Somasekhara Menakuru, MBBS, MS, MRCS, DPM, MFPM · Quotient Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-16
Primary Completion
2024-05-20
Completion
2024-05-20

Countries

  • United Kingdom

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06157255 on ClinicalTrials.gov