A Randomised, Double-blind, Placebo-controlled, Dose Ascending, Five-way Crossover Study, to Examine Efficacy, Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of a Single Administration of Three Inhaled Doses (25, 100 and 400 µg) of GW642444M
Overview
- Phase
- Phase 2
- Intervention
- GW642444M
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- GlaxoSmithKline
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Adverse events
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This is a study of GW642444M, a long-acting beta 2 specific agonist. This study will examine GW642444M via the inhaled route and will assess the efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of a single administration of three inhaled doses (25, 100 and 400 µg) of GW642444M in persistent asthmatics. This study will be a single-centre, placebo-controlled, dose-ascending, five-way crossover in 30 asthmatic patients.
Key assessments: efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics will be assessed by measurement of FEV1, blood pressure, pulse rate, 12-lead ECGs, clinical laboratory safety tests, collection of adverse events and blood samples.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
GW642444M 12.5
Intervention: GW642444M
GW642444M 100mcg
Intervention: GW642444M
GW642444M 400mcg
Intervention: GW642444M
GW642444H 100mcg
Intervention: GW642444H
Placebo
Intervention: placebo
Outcomes
Primary Outcomes
Adverse events
Time Frame: throughout study
Mean change from baseline FEV1 24 hours after dosing.
Time Frame: Day 1, on 5 separate occasions
Laboratory safety tests
Time Frame: throughout study
Holter monitoring
Time Frame: throughout study
Vital signs and 12-lead ECG)
Time Frame: throughout study
Supine systolic and diastolic blood pressure and supine heart rate
Time Frame: Day 1 on 5 separate occasions
QTc(B)and QTc(F)
Time Frame: Day 1 on 5 separate occasions
Secondary Outcomes
- Mean change from baseline(0-4h)potassium.(Day 1 on 5 separate occasions)
- Glucose Max increase from baseline(Day 1 on 5 separate occasions)
- Potassium Max decrease from baseline(Day 1 on 5 separate occasions)
- Weighted mean change from baseline (0-4h)glucose(Day 1 on 5 separate occasions)
- Derived PK parameters: Cmax, Tmax, AUC(0-t), AUC(0-inf),PEFR(Day 1 on 5 separate occasions)