THE IMPACT OF CENTRAL RATING REVIEW PROGRAMS ON ADAS-COG ERROR VARIANCE

D4010 tablets. For multiple ascending dose evaluation, the once daily doses of SUVN-D4010 tablets were administered for 14 days. SUVN-D4010 was quantified in plasma and urine using a validated LC-MS/MS method. Safety was evaluated based on assessments of adverse events, physical examinations, laboratory tests, vital signs, orthostatic vital signs, 12-lead ECGs and continuous telemetry. Results: SUVN-D4010 was well tolerated in healthy male subjects and there were no clinically relevant or serious adverse events reported. During single ascending dose studies, the absorption of SUVN-D4010 is rapid and exposures (Cmaxand AUC) were dose proportional at the tested doses. During multiple ascending dose studies, SUVN-D4010 has shown a favorable pharmacokinetic profile. SUVN-D4010 achieved the projected efficacy concentrations and attained steady state on day 3 in the tested population. Conclusions: SUVN-D4010 has favorable safety and pharmacokinetic profile following single and multiple administration for 14 days in healthymale subjects. SUVN-D4010 exposures were dose proportional following single or multiple oral administrations. SUVN-D4010 achieved the projected efficacy concentrations and attained steady state on day 3 upon multiple administrations. SUVN-D4010 is well tolerated with adequate plasma exposure for efficacy and favorable pharmacokinetics suitable for once a day oral administration. Long term non-clinical safety studies are in progress and Phase II proof-of-concept studies is being planned.