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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-004448-35 |
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The primary objective of the study is to investigate the safety and tolerability of single and multiple once daily ascending doses of AZD3199 delivered as dry powder via the Turbuhaler inhaler in healthy male Japanese subjects by assessment of incidence and nature of adverse events (AEs), clinically significant abnormalities in ECG parameters, blood pressure (BP), pulse rate, lung function parameters, body temperature and laboratory variables (clinical chemistry, haematology and urinalysis). The secondary objectives of the study are to investigate the pharmacokinetics (PK) of single and multiple ascending doses of AZD3199 by assessment of the degree of accumulation, dose proportionality and time linearity in healthy Japanese subjects, and to investigate systemic β 2- adrenoreceptor mediated effects of single and multiple ascending doses of AZD3199 by assessment of potassium and lactate concentrations, tremor and palpitations, heart rate, QTc, pulse rate, blood pressure and FEV1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Dry powder for oral inhalation |
|
| 2 | Placebo Comparator | Dry powder for oral inhalation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD3199 Turbuhaler® | Drug | 240, 720 and 2160 μ g, single and multiple (o.d. for 12 days) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety/Tolerability - adverse events (AEs), clinically significant abnormalities in ECG parameters, blood pressure (BP), pulse rate, lung function parameters, body temperature and laboratory variables (clinical chemistry, haematology and urinalysis) | During the study |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameters derived from plasma concentration and optionally urinary excretion of AZD3199. | During residential period | |
| Pharmacodynamic Potassium and lactate concentrations, tremor and palpitations, heart rate, QTc, pulse rate, blood pressure, and forced expiratory volume in one second (FEV1). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronnie Beboso | Chiltern Clinical Research Unit (CCRU). | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Slough | Berkshire | United Kingdom |
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| Placebo Turbuhaler® |
| Drug |
single and multiple (o.d. for 12 days) |
|
| During residential period |