This study will investigate the safety and tolerability of AZD2115 following administration of multiple ascending doses.
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Inhaled Doses of AZD2115 in Healthy Male Subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
32
Research Site
London, UK, United Kingdom
Description of the safety profile in terms of adverse events, blood pressure, pulse, temperature, ECG (Electrocardiogram), lung function (Spirometry), physical examination, safety labs
No formal statistical tests will be performed. Abnormalities will be listed without statistical analysis
Time frame: baseline, up to 30 days
Description of the pharmacokinetics (PK) of AZD2115 in terms of area under the curve over the time (AUC) and maximum concentration (Cmax) and terminal half-life
PK samples collected post-dose at 5mins, 20mins, 40mins, 1hr, 1.5hrs, 2 hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs 36 hrs, 48hrs
Time frame: day 1
Description of pharmacokinetics (PK) of AZD2115 in terms of Cmax, area under the plasma concentration-time curve from zero to the end of the dosing interval (AUC(0-τ))
PK samples collected post-dose at 5mins, 20mins, 40mins, 1hr, 1.5hrs, 2 hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs 36 hrs, 48hrs 72hrs, 96hrs, 120hrs and 168hrs.
Time frame: day 17
Description of achievement of plasma drug concentration steady state
An exploratory analysis of achievement of steady state will be evaluated graphically.
Time frame: PK samples collected pre-dose on day 1, day 4, day 6, day 10, day 14, day 17
Description of pharmacodynamics of AZD2115 in terms of FEV1 (forced expiratory volume in the first second), FVC (forced vital capacity), potassium, glucose, systolic and diastolic blood pressure, pulse rate, heart rate, QTcF
QTcF defined as QT interval corrected for heart rate using Fridericia's formula
Time frame: day 1, day 17
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