Clinical trial NCT01338350: Safety, Pharmacokinetics and Pharmacodynamics After Single and Multiple Dosing of AZD5423 in Japanese Healthy Male Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: safety
tolerability
pharmacokinetics
pharmacodynamics
AZD5423
Japanese
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-04-19
Enrollment: 96
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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.
timeFrame: 10-14 days after last dose
Secondary outcomes:
measure: 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.
timeFrame: 72 hours after last dose
measure: 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.
timeFrame: 10-14 days after last dose
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Research Site
Study officials:
References: