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AZD8630 Inhalers for Healthy Subjects

Phase 1
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a BMI between 18 and 32 kg/m2 inclusive and weigh at least 45 kg.
All females must have a negative serum pregnancy test at the Screening Visit
Must not have
History of cancer within the last 10 years (20 years for breast cancer) except for specified cases
History or presence of gastrointestinal, hepatic, or renal disease or any condition known to interfere with drug metabolism
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening (day -28) to follow-up visit (7 days post last dose of azd8630)
Awards & highlights

Summary

"This trial aims to compare how a new medication, AZD8630, works in the body compared to the current standard medication, AZD8630. The study will look at how the medications are

Who is the study for?
This clinical trial is open to healthy individuals. Specific eligibility criteria are not detailed, but typically participants should have no significant health issues and meet certain age and weight requirements.
What is being tested?
The study is testing the absorption and effects of a drug called AZD8630 when inhaled through two different devices: a test inhaler and a standard Monodose inhaler. It compares how the body processes the drug with each method.
What are the potential side effects?
Since this trial involves healthy volunteers, side effects may include typical reactions to inhaled substances such as coughing, throat irritation, or mild respiratory discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My BMI is between 18 and 32, and I weigh at least 45 kg.
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I am not pregnant, as confirmed by a blood test.
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My lung function test shows normal results for my age, height, gender, and ethnicity.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had cancer in the last 10 years, or breast cancer in the last 20 years, except for certain types.
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I have no liver, kidney, or stomach conditions affecting drug processing.
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I have been treated for hepatitis B or C.
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I have a history of immune system disorders or worm infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening (day -28) to follow-up visit (7 days post last dose of azd8630)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening (day -28) to follow-up visit (7 days post last dose of azd8630) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area under the serum concentration-time curve from time zero to the last quantifiable concentration test/Monodose
Secondary study objectives
Apparent total body clearence of drugfrom plasma after extravascularadministration (CL/F)
Area under the plasma concentration curve from zero to 24 (AUC [0-24])
Area under the plasma concentration curve from zero to infinity (AUCinf)
+13 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sequence 2 (Treatment B- Treatment A)Experimental Treatment4 Interventions
Participants will receive Treatment B (AZD8630 test inhalation powder) crossover to Treatment A (AZD8630 Monodose inhalation powder)
Group II: Sequence 1 (Treatment A- Treatment B)Experimental Treatment4 Interventions
Participants will receive Treatment A (AZD8630 Monodose inhalation powder) crossover to Treatment B (AZD8630 test inhalation powder)

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,352 Previous Clinical Trials
288,646,781 Total Patients Enrolled
~0 spots leftby Oct 2024
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