Healthy Volunteers
Conditions
Keywords
Healthy male, tolerability, safety, inhalation
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
Interventions
DRUGAZD3199
Low dose Dry powder for inhalation, o.d., 1+12 days
DRUGPlacebo
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and nature of Adverse Events | Before, during and after dosing |
| Clinical significant abnormalities in ECG, pulse, blood pressure, lung function, temp, lab | Before, during and after dosing |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | Before, during and after dosing |
| 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 |
Countries
Sweden
Outcome results
None listed