A study in healthy subjects and mild asthmatics to investigate Pharmacokinetics of AZD5423 when administered in different ways.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
solution for injection, administered as intravenous infusion Corr to total dose of 250µg AZD5423
nebuliser suspension, inhaled via Spira, corr to approximately 300 µg lung deposited dose AZD5423
nebuliser suspension, inhaled via I-neb, corr to approximately 300 µg lung deposited dose AZD5423
Research Unit
London, United Kingdom
Pharmacokinetics of AZD5423 measured by: Absolute bioavailability (F)
Time frame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
Pharmacokinetics of AZD5423 measured by: Pulmonary bioavailability (Fpulmonary)
Time frame: 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)
Time frame: 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).
Time frame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
To compare the pharmacokinetics between healthy subjects and asthma patients and estimate the basic pharmacokinetic parameters of AZD5423 by measuring e.g. maximum plasma concentration, Cmax
Time frame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
To evaluate the safety and tolerability of AZD5423 measured by adverse events, laboratory variables, physical examination, electrocardiograms, blood pressure and pulse, and spirometry.
To evaluate the safety and tolerability of AZD5423 measured by (Adverse events) (Laboratory variables) (Physical examination) (Electrocardiograms) (blood pressure and pulse) (Spirometry)
Time frame: From screening to follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
nebuliser suspension to be administered orally, corr to a total dose of 1200 µg AZD5423