Study design
We carried out a single center, randomized double-blind,
placebo-controlled, double dummy, three-way crossover trial in healthy
volunteers comparing the effects of a single dose of lesogaberan 120mg
Modified Release (MR), baclofen 40mg and matched placebos on evoked
cough responses to capsaicin (Figure1; Study overview). Participants
were dosed with either lesogaberan plus baclofen placebo, lesogaberan
placebo plus baclofen or lesogaberan placebo plus baclofen placebo.
Capsaicin cough challenge was performed at screening and then repeated
on each study day at 2h post dosing which was the peak serum
concertation (Cmax) for both therapies. The washout
period between doses was ≥7 days.