Safety, Pharmacokinetics and Pharmacodynamics After Single and Multiple Dosing of AZD5423 in Japanese Healthy Male Subjects
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The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects (24-hours plasma cortisol area under curve, plasma cortisol pre and post ACTH stimulation, dehydroepiandrosterone sulphate (DHEAS), osteocalcin and 24 hours urine cortisol) of AZD5423 following administration of single and multiple ascending doses in healthy male Japanese subjects.
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled AZD5423 After Administration of Single and Multiple Ascending Doses in Healthy Male Japanese Subjects
To investigate the safety and tolerability (AE, blood pressure, pulse, ECG, Body temp, Haematology, Clin Chemistry, Urinalysis, phys exam, lung function) of AZD5423 following administration of single and multiple ascending doses. [ Time Frame: 10-14 days after last dose ]
Secondary Outcome Measures :
To characterise the single and multiple dose pharmacokinetics of AZD5423, and assess the dose proportionality, the time required to reach steady state and the degree of accumulation. [ Time Frame: 72 hours after last dose ]
To investigate the pharmacodynamic effects (24-hours plasma cortisol AUC, plasma cortisol pre and post ACTH stimulation, DHEAS, osteocalcin and 24 hours urine cortisol) of AZD5423 following administration of single and multiple ascending doses. [ Time Frame: 10-14 days after last dose ]
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Layout table for eligibility information
Ages Eligible for Study:
20 Years to 45 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Provision of signed and dated, written informed consent prior to any study specific procedures
Healthy male Japanese subjects aged 20 to 45 years with suitable veins for cannulation or repeated venepuncture
Male subjects should be willing to use barrier contraception ie, condoms, from the day of dosing until 3 months after the last dose of investigational product
Have a body mass index (BMI) between 18 and 27 kg/m2 and weight at least 50 kg and no more than 80 kg
Be able to inhale from the I-nebⓇ according to given instruction
History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs
Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of investigational product
Any clinically significant abnormalities in clinical chemistry, haematology, urinalysis or physical examination results as judged by the investigators
Any positive results on screening for serum hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV) and Syphilis