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• W2620874157 abstract "Leuprolide acetate is an investigational drug being assessed by Voyager Pharmaceutical for its ability to stabilize cognition in Alzheimer's patients. VP4896 is a proprietary formulation of leuprolide administered as a dissolvable, sustained release implant. The results of the Phase I study of the VP4896 implant are reported. The primary objective of the study was to determine the safety and tolerability of VP4896 (leuprolide acetate) implants. The secondary objective was to study the pharmacokinetics of VP4896 implants and to compare them with that of a leuprolide microsphere depot formulation. VP–AD–105 was a single–center, double–blind, placebo controlled, multiple dose and formulation comparison safety study in healthy volunteers. Leuprolide acetate was administered as either subcutaneous implants or a marketed microsphere depot injection. Leuprolide was well tolerated with no evidence of increased frequency of adverse events with repeated doses of implants. There were no clinically significant findings or safety signals. The safety profile of leuprolide implants was entirely consistent with that for marketed leuprolide depot injection. The leuprolide implants give a predictable systemic release of leuprolide over an 8 week dosing interval with mean serum concentrations between 0.63 and 1.74 ng/mL following two implants and 1.0 to 4.2 ng/mL following four implants. In contrast, serum concentrations decrease rapidly after 24 hours following leuprolide depot injection. The implant avoids the initial burst release seen with depot injections and there is a lower Cmax and acute systemic exposure in the first 24 hours with the implant. Following the first 24 hours, steady serum concentrations are established, rising slowly to a peak at approximately 4 weeks, thereafter declining slowly to the end of the 8 week dosing period. There was no evidence of dose accumulation when subjects received two implants on a second occasion; indeed the pharmacokinetic profile is remarkably consistent following the first and second dosing periods. This Phase I study indicates that VP4896 implants are well tolerated and do not elicit any clinically significant safety signals or adverse events. Pharmacokinetic analysis shows dose proportionality and no dose accumulation when administered at 8–week intervals. Steady state leuprolide levels are maintained throughout the dosing period." @default.
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• W2620874157 date "2006-07-01" @default.
• W2620874157 modified "2023-09-26" @default.
• W2620874157 title "P3-465: A phase I study in healthy volunteers to assess the safety, tolerability and pharmacokinetics of leuprolide, an investigational Alzheimer's disease drug, when administered by sustained release implant" @default.
• W2620874157 doi "https://doi.org/10.1016/j.jalz.2006.05.1736" @default.
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