Rorick-Kehn Linda M, Witcher Jennifer W, Lowe Stephen L, Gonzales Celedon R, Weller Mary Ann, Bell Robert L, Hart John C, Need Anne B, McKinzie Jamie H, Statnick Michael A, Suico Jeffrey G, McKinzie David L, Tauscher-Wisniewski Sitra, Mitch Charles H, Stoltz Randall R, Wong Conrad J
Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana (Drs Rorick-Kehn, Witcher, Lowe, Gonzales, Bell, Hard, Need, J. McKinzie, Statnick, Suico, D. McKinzie, Tauscher-Wisniewski, Mitch, and Wong); inVentiv Health Clinical, Ann Arbor, Michigan (Dr Weller); Covance Clinical Research Unit, Inc., Evansville, Indiana (Dr Stoltz).
Int J Neuropsychopharmacol. 2014 Oct 31;18(2):pyu036. doi: 10.1093/ijnp/pyu036.
Selective kappa opioid receptor antagonism is a promising experimental strategy for the treatment of depression. The kappa opioid receptor antagonist, LY2456302, exhibits ~30-fold higher affinity for kappa opioid receptors over mu opioid receptors, which is the next closest identified pharmacology.
Here, we determined kappa opioid receptor pharmacological selectivity of LY2456302 by assessing mu opioid receptor antagonism using translational pupillometry in rats and humans.
In rats, morphine-induced mydriasis was completely blocked by the nonselective opioid receptor antagonist naloxone (3mg/kg, which produced 90% mu opioid receptor occupancy), while 100 and 300 mg/kg LY2456302 (which produced 56% and 87% mu opioid receptor occupancy, respectively) only partially blocked morphine-induced mydriasis. In humans, fentanyl-induced miosis was completely blocked by 50mg naltrexone, and LY2456302 dose-dependently blocked miosis at 25 and 60 mg (minimal-to-no blockade at 4-10mg).
We demonstrate, for the first time, the use of translational pupillometry in the context of receptor occupancy to identify a clinical dose of LY2456302 achieving maximal kappa opioid receptor occupancy without evidence of significant mu receptor antagonism.
选择性κ阿片受体拮抗作用是一种很有前景的抑郁症治疗实验策略。κ阿片受体拮抗剂LY2456302对κ阿片受体的亲和力比对μ阿片受体高约30倍,μ阿片受体是其次最接近的已确定药理学靶点。
在此,我们通过在大鼠和人类中使用转化瞳孔测量法评估μ阿片受体拮抗作用,来确定LY2456302的κ阿片受体药理学选择性。
在大鼠中,非选择性阿片受体拮抗剂纳洛酮(3mg/kg,可产生90%的μ阿片受体占有率)可完全阻断吗啡诱导的瞳孔散大,而100mg/kg和300mg/kg的LY2456302(分别产生56%和87%的μ阿片受体占有率)仅部分阻断吗啡诱导的瞳孔散大。在人类中,50mg纳曲酮可完全阻断芬太尼诱导的瞳孔缩小,而LY2456302在25mg和60mg时剂量依赖性地阻断瞳孔缩小(在4 - 10mg时最小至无阻断)。
我们首次证明,在受体占有率的背景下使用转化瞳孔测量法来确定LY2456302的临床剂量,该剂量可实现最大的κ阿片受体占有率且无明显μ受体拮抗作用的证据。