A Study in Healthy Subjects to Investigate Pharmacokinetics of AZD5423 When Administered in Different Ways
Status and phase
Conditions
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Study type
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Identifiers
Details and patient eligibility
About
The purpose of this study is to look at drug levels of AZD5423 in blood when the drug is administered in different ways - orally, intravenously or inhaled (with four different devices), to healthy subjects
Full description
A Phase I, Single Centre, Open, Partly Randomised, Crossover Study in Healthy Subjects to Evaluate AZD5423 Absolute Pulmonary Bioavailability when Administered Inhaled via a New Dry Powder Inhaler, Turbuhaler, Spira nebulizer and I-neb AAD system
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Healthy male or women of non-childbearing potential aged 18-45 years inclusive with suitable veins for cannulation or repeated vein puncture
- Have a body mass index (BMI) between 19 and 30 kg/m2 (inclusive and rounding allowed) and weight between 50 and 100 kg (inclusive)
- Be able to inhale from the inhaler devices used in the study according to given instructions as well as be able to perform spirometry
Exclusion criteria
- History of any clinically significant disease or disorder
- Current smokers
- Any clinically relevant abnormal findings
Trial design
Primary purpose
Allocation
Interventional model
Masking
18 participants in 6 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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