NCT00713271
Completed
Phase 1
A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel-group, Single-centre Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of AZD3199 (a B2-agonist) Given Once Daily as Inhaled Formulation Via Turbuhaler to Healthy Men
Overview
- Phase
- Phase 1
- Intervention
- AZD3199
- Conditions
- Healthy Volunteers
- Sponsor
- AstraZeneca
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Incidence and nature of Adverse Events
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to investigate the safety and tolerability of multiple once daily ascending doses of AZD3199 in healthy men
Investigators
Eligibility Criteria
Inclusion Criteria
- •BMI 19-30, weight 60-100 kg
- •Non/ex-smokers, Non/ex-nicotine users
Exclusion Criteria
- •Any clinically significant disease or disorder
- •Any clinically relevant abnormal findings at screening examinations
- •Use of any prescribed or non-prescribed medication
Arms & Interventions
1
Low dose
Intervention: AZD3199
2
intermediate dose
Intervention: AZD3199
3
high dose
Intervention: AZD3199
4
Intervention: Placebo
Outcomes
Primary Outcomes
Incidence and nature of Adverse Events
Time Frame: Before, during and after dosing
Clinical significant abnormalities in ECG, pulse, blood pressure, lung function, temp, lab
Time Frame: Before, during and after dosing
Secondary Outcomes
- Potassium and lactate concentrations(Before, during and after dosing)
- Tremor, palpitations, heart rate, QTc, pulse and blood pressure and FEV1(Before, during and after dosing)
- Pharmacokinetics(Before, during and after dosing)
Study Sites (1)
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