Effects on the Respiratory System in Rats (Study no. YL18404). Four groups of eight male rats were given a single oral administration of STP0404 at doses of 100, 300 and 600 mg/kg. STP0404 was administered as a suspension in 0.5% MC in a volume of 10 mL/kg. Eight control males received the vehicle, 0.5 w/v% methylcellulose solutions, in a similar manner. Measurements were conducted at pre-dosing and 0.5, 1, 3, 6 12 and 24 hrs post-dosing, and respiratory rate, tidal volume and minute volume were investigated (INA Research, Japan). Effects on the Central Nervous System in Rats (Study no. YL18405). Four groups of six male rats were given a single oral administration of STP0404 at doses of 0 (vehicle), 100, 300 and 600 mg/kg. The test article was administered as a suspension in 0.5% MC in a volume of 10 mL/kg. Six control males received the vehicle, 0.5 w/v% methylcellulose solutions, in a similar manner. Blinded observations were conducted pre-dosing and 0.5, 1, 3, 6, 12 and 24 hrs post-dosing on rats body temperature, pupil size, landing foot-splay and grip strength in functional observational battery. Effects on the Cardiovascular System in Dogs (Study no. YL18406). STP0404 at dose levels of 30, 60 and 90 mg/kg were administered orally (by capsules) to four male Beagle dogs in a design with 7-day intervals between doses. Heart rate, blood pressure (systolic, diastolic and mean) and electrocardiographic (ECG) parameters (PR, QT and QTc intervals and QRS duration) were evaluated at pre-dosing and 0.5, 1, 2, 4, 8 and 24 hrs post-dosing. Control animals received empty gelatin capsules in a similar manner for comparison. This test was conducted by a fee to service through INA Research (INA Research, Japan).

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