Results of the survey indicated preference for structure and standardization of the ADASCog worksheets, which has been considered in the development of a standard ADAS-Cog source document by the Alzheimer's Disease Cooperative Study (ADCS) Working Group.
dose, subjects were dosed with 5, 15, 30 and 45 mg of SUVN-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 (C max and 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 healthy male 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.
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