Study to Evaluate the Pharmacokinetics and Pharmacodynamics of AZD4604 Given Via the Turbuhaler® … (NCT06732882) | Clinical Trial Compass
CompletedPhase 1
Study to Evaluate the Pharmacokinetics and Pharmacodynamics of AZD4604 Given Via the Turbuhaler® Device in Adults With Mild Asthma.
Germany, United Kingdom28 participantsStarted 2025-02-27
Plain-language summary
The study will investigate the Pharmacokinetic (PK), Pharmacodynamic (PD), the safety and tolerability of AZD4604, as well as to examine the effect of Fractional exhaled Nitric Oxide (FeNO) following the administration of the multiple doses of AZD4604 via Turbuhaler device.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Main Inclusion Criteria:
* Participant must be 18 to 65 years of age inclusive with suitable veins for cannulation or repeated venepuncture.
* Participants must have Physician-diagnosed mild asthma for at least 6 months prior to Screening Visit.
* ≥ 70% predicted for FEV1 at the Screening Visit AND on Day -1.
* Have a FeNO of ≥ 40 ppb at the Screening Visit and on Day -2.
* Body weight at least 50 kg and BMI within the range 18 to 35 kg/m2 (inclusive).
* Female participants must have a negative pregnancy test at the Screening Visit and on admission to the clinical site or prior to randomisation and must not be lactating. However, there are no restrictions on male participants or their female partners.
* Contraceptive use by females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Capable of giving signed and dated informed consent prior to any study-specific procedure.
Main Exclusion Criteria:
* History of any clinically important disease or disorder which, in the opinion of the Principal Investigator (PI), may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
* History of cancer within the last 10 years (20 years for breast cancer) except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured. Any history of lymphoma is not allow…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum observed drug concentration (Cmax) of AZD4604
Timeframe: Day 9 (Pre-dose) and Day 10 (Pre-dose and Post-dose)
2
Time to reach maximum observed concentration (tmax) of AZD4604
Timeframe: Day 9 (Pre-dose) and Day 10 (Pre-dose and Post-dose)
3
Area under concentration-time curve in the dosing interval (AUCtau) of AZD4604
Timeframe: Day 9 (Pre-dose) and Day 10 (Pre-dose and Post-dose)
4
Apparent total body clearance (CL/F) of AZD4604
Timeframe: Day 10 (Pre-dose and Post-dose)
5
Apparent volume of distribution based on the terminal phase (VZ/F) of AZD4604
Timeframe: Day 10 (Pre-dose and Post-dose)
6
Dose normalised AUCtau (AUCtau/D) of AZD4604
Timeframe: Day 9 (Pre-dose) and Day 10 (Pre-dose and Post-dose)
7
Dose normalised Cmax (Cmax/D) of AZD4604
Timeframe: Day 9 (Pre-dose) and Day 10 (Pre-dose and Post-dose)