Primary Outcome Measures:
- ECG monitoring during 24 hours after each dose in the single dose cohorts and on days 1 and 7 in the repeat dose cohorts. [ Time Frame: during 24 hours after each dose in the single dose cohorts and on days 1 and 7 in the repeat dose cohorts. ]
- Heart rate and blood pressure changes over 24 hours after dosing in single and repeat dose cohorts [ Time Frame: over 24 hours after dosing in single and repeat dose cohorts ]
Secondary Outcome Measures:
- Change in plasma drug concentration (AUC, Cmax, t1/2, tmax) [ Time Frame: over 24 hours after dosing. ]
- Changes in histamine-induced wheal and flare measurements [ Time Frame: over 24 hours after dosing. ]
- Derived pharmacokinetic parameters for GSK835726 including area under the plasma drug concentration versus time curve (AUC(0-t), AUC(0-¥)), maximum observed plasma drug concentration (Cmax),
- time to maximum observed plasma drug concentration (tmax), apparent clearance (CL/F) and terminal half life (t1/2) following single and repeat oral dosing.
A double-blind, placebo controlled, randomized cross-over single dose escalation study and a double-blind, placebo controlled, randomised parallel group 7-days once daily repeat dose study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of oral H1/H3 dual antagonist compound in healthy male subjects