Pharmacokinetics, pharmacodynamics, safety, tolerability, and mass balance of single and continuous intravenous infusion of SPT-07A in healthy volunteers.

European Journal of Clinical Pharmacology
Weicong WangXia Chen

Abstract

SPT-07A is an intravenous injection of (+)-2-borneol being developed for the treatment of acute ischemic stroke. This study aimed to investigate the pharmacokinetics, pharmacodynamics, safety, tolerability, and mass balance of SPT-07A after sequentially administered single and multiple infusions of SPT-07A at 10 mg, 20 mg, or 40 mg. This phase I, double-blind, randomized, placebo-controlled, dose-escalation study was conducted in 36 Chinese healthy volunteers. Each cohort enrolled 12 eligible subjects, who were 9:3 randomized to receive SPT-07A or matching placebo during the two study occasions, that is, an initial single-dose occasion followed by a 7-day multiple-dose occasion with a dosing interval of 12 h. Pharmacokinetic, pharmacodynamic assessments regarding effects on the central nervous system (CNS) were performed pre-dose and several times post-dose. Safety and tolerability were evaluated throughout the study for each cohort. Following single intravenous (i.v.) administration of 10 mg to 40 mg SPT-07A, the plasma SPT-07A concentration reached its peak by the end of infusion. Thereafter, the plasma concentration declined in a multiphase exponential manner with an average terminal elimination half-life of 3.85 to 8.93 h. ...Continue Reading

References

May 20, 2008·Cardiovascular Therapeutics·Toshiaki WatanabeSatoru Todo
Aug 16, 2008·Stroke; a Journal of Cerebral Circulation·Malcolm R MacleodDavid W Howells
Sep 26, 2008·The New England Journal of Medicine·Werner HackeUNKNOWN ECASS Investigators
Feb 28, 2009·Stroke; a Journal of Cerebral Circulation·Marc FisherUNKNOWN STAIR Group
Mar 5, 2011·European Neurology·Bin ZhangChi-heng Ju
Mar 1, 2012·Advances in Pharmacological Sciences·Xia ChenJoop van Gerven
Jun 29, 2013·European Journal of Clinical Pharmacology·Qing-qing DuLing Wang
Jun 2, 2015·JAMA Neurology·Randolph S Marshall
Dec 20, 2015·Brain : a Journal of Neurology·Takeshi HiuGary K Steinberg
Dec 7, 2016·British Journal of Clinical Pharmacology·Xia ChenJoop van Gerven
Mar 8, 2017·European Journal of Clinical Pharmacology·Sun Ku LeeMiroslawa Nowak
May 21, 2017·Anesthesiology Clinics·Mariah Kincaid TaniousRichard D Urman

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