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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD5423 | Drug | Inhalation, suspension |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10-14 days after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Fukuoka | Japan |
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| Label | URL |
|---|---|
| CSR Synopsis | View source |
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| ID | Term |
|---|---|
| C587250 | 2,2,2-trifluoro-N-(1-((1-(4-fluorophenyl)-1H-indazol-5-yl)oxy)-1-(3-methoxyphenyl)-2-propanyl)acetamide |
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| Drug |
Inhalation, solution |
|
| 10-14 days after last dose |