5 results
Single dose:The objectives of Part 1 (single dose escalation part) are to examine the safety, tolerability and pharmacokinetics (i.e., the circulating levels of TMC558445 in your blood over time) of increasing single oral doses of TMC558445, with…
This study, a three-phased cross-over study, aims to define a proper formulation for oral and oromucosal melatonin by investigating the Tmax and relative bioavailability derived from melatonin levels in salivary samples of healthy volunteers after…
Primary:To determine the efficacy of AG10 in the treatment of subjects with symptomatic transthyretin amyloid polyneuropathy (ATTR-PN) by evaluating the difference between the AG10 and placebo groups in Modified Neuropathy Impairment Score + 7 (mNIS…
Primary• To assess safety and tolerability of acoramidis in participants with symptomatic transthyretin amyloid cardiomyopathy (ATTR-CM)Secondary• To evaluate the effect of acoramidis on all-cause mortality and cardiovascular (CV) mortality• To…
Key PrimaryPart A• To determine the efficacy of acoramidis (AG10) in the treatment of subjects with symptomatic transthyretin amyloid cardiomyopathy (ATTR-CM) by evaluating the difference between the acoramidis and placebo groups in the change from…