. Author manuscript; available in PMC: 2020 Dec 1.

Published in final edited form as: Regul Toxicol Pharmacol. 2019 Sep 30;109:104483. doi: 10.1016/j.yrtph.2019.104483

Table 2.

Dog study design

Group	Dose (mg/kg/day)	Formulation Concentration (mg/mL)	Number of Dogs
			Core^a/Recovery^b Cohort		Fed-TK

			M	F	M	F
1- Control	0	0	5	5	-	-
2- Low Dose	5	1	5	5	-	-
3- Mid Dose	20	4	5	5	-	-
4- High Dose	75^c	15	5	5	-	-
5- Mid Dose Fed TK^d	20	4	-	-	2	2

^a.

Core Groups (3 dogs/sex/group) Necropsy Day = Day 29

^b.

Dosing discontinued on Day 29. Recovery Groups (2 dogs/sex/group) Necropsy Day = Day 50

^c.

75 mg/kg/day dose was the maximum feasible dose based on the solubility of JD5037 in the formulation.

^d.

The dogs in the Fed-TK group were dosed only once on the last day of dose administration to evaluate the toxicokinetics of JD5037 under fed conditions. These dogs were fasted overnight prior to dose administration and on the day of dose administration these dogs had ad libitum access to food for 3 to 4 hours before dose administration and throughout the completion of TK blood collection