CompletedPhase 1

A Study in Healthy Subjects and Mild Asthmatics to Investigate Pharmacokinetics of AZD5423 When Administered in Different Ways

United Kingdom12 participantsStarted 2011-04

Plain-language summary

A study in healthy subjects and mild asthmatics to investigate Pharmacokinetics of AZD5423 when administered in different ways.

Who can participate

Age range

18 Years – 45 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male healthy subjects and male asthma patients aged 18 to 45 years (inclusive) * Have a body mass index (BMI) between 18 and 30 kg/m2 (inclusive and rounding allowed) and weight between 50 and 100 kg (inclusive) * Be able to inhale from the SPIRA nebuliser and I-neb® according to the provided instructions * Asthma patients should fulfil the following criteria: Pre-bronchodilator forced expiratory volume at 1 second (FEV1) ≥70% of predicted normal value * Asthma diagnosis according to GINA guidelines with a history of episodic wheeze and shortness of breath Exclusion Criteria: * History of any clinically significant disease or disorder * Any clinically relevant abnormal findings * Current smokers * Asthma patients: Worsening of asthma or respiratory infection within 6 weeks before screening * Asthma patients: Use of inhaled, nasal, oral, rectal or parenteral corticosteroids within 30 days before first administration of investigational product and during the study

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

Pharmacokinetics of AZD5423 measured by: Absolute bioavailability (F)

Timeframe: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period

Pharmacokinetics of AZD5423 measured by: Pulmonary bioavailability (Fpulmonary)

Timeframe: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period

Pharmacokinetics of AZD5423 measured by: Oral bioavailability after inhaled treatments (Foral)

Timeframe: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period

Pharmacokinetics of AZD5423 measured by: Area under the plasma concentration-time curve from time zero to infinity (AUC).

Timeframe: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period

Trial details

NCT IDNCT01310322

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-10

View on ClinicalTrials.gov More Healthy trials