Study identifier:D0570C00005
ClinicalTrials.gov identifier:N/A
EudraCT identifier:2008-004448-35
CTIS identifier:N/A
A phase I, randomised, double-blind, placebo-controlled, parallel-group, single-centre study to investigate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of AZD3199 given once daily as inhaled formulation via Turbuhaler to Japanese healthy men
Healthy
Phase 1
Yes
AZD3199 Turbuhaler®, Placebo Turbuhaler®
Male
27
Interventional
20 Years - 45 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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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.
Location
Location
Slough, Berkshire, United Kingdom
Arms | Assigned Interventions |
---|---|
Experimental: 1 Dry powder for oral inhalation | Drug: AZD3199 Turbuhaler® 240, 720 and 2160 μ g, single and multiple (o.d. for 12 days) |
Placebo Comparator: 2 Dry powder for oral inhalation | Drug: Placebo Turbuhaler® single and multiple (o.d. for 12 days) |
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