Table 1

Dose-response analysis of (−)DS121 at CT-05 on sleep/wake architecture and physiological parameters^1-a

Parameter	Period	Dose (−)DS121 in mg/kg		ANOVA
Parameter	Period	Vehicle	0.5	ANOVA	1	5	10
Sample size (n)		20	11	8	11	13
ASBL (min)	1. Baseline	3.1 ± 0.1	3.1 ± 0.1	3.1 ± 0.1	3.2 ± 0.2	3.3 ± 0.2
	2. Treatment	3.9 ± 0.1	3.3 ± 0.3	3.0 ± 0.3	3.0 ± 0.5	1.9 ± 0.5^1-150	F(4,61) = 5.06, P < .005
	3. Recovery	3.4 ± 0.3	2.7 ± 0.2	3.1 ± 0.2	5.5 ± 1.0^1-150	5.1 ± 0.3^1-150	F(4,62) = 6.07, P < .001
MSBL (min)	1. Baseline	7.6 ± 0.2	7.5 ± 0.4	7.6 ± 0.6	7.7 ± 0.2	8.4 ± 0.3
	2. Treatment	8.9 ± 0.5	8.3 ± 0.8	7.3 ± 0.7	7.0 ± 0.9	4.9 ± 1.4^1-150	F(4,61) = 3.60, P < .05
	3. Recovery	7.5 ± 0.6	6.9 ± 0.5	7.3 ± 0.6	12.7 ± 1.7^1-150	12.1 ± 0.6^1-150	F(4,62) = 9.74, P < .001
AWBL (min)	1. Baseline	3.7 ± 0.1	4.3 ± 0.3	4.9 ± 0.5	4.1 ± 0.3	4.1 ± 0.2
	2. Treatment	4.5 ± 0.7	5.3 ± 0.8	14.6 ± 5.2	34.1 ± 5.6^1-150	74.3 ± 5.8^1-150	F(4,62) = 63.50, P < .001
	3. Recovery	4.0 ± 0.2	4.6 ± 0.7	4.5 ± 0.3	3.4 ± 0.2	5.1 ± 1.2
MWBL (min)	1. Baseline	13.9 ± 0.3	15.9 ± 1.1	17.1 ± 1.3	14.6 ± 0.9	14.9 ± 0.7
	2. Treatment	10.8 ± 0.6	11.4 ± 1.0	22.7 ± 5.7	40.4 ± 4.9^1-150	78.4 ± 5.7^1-150	F(4,62) = 64.02, P < .001
	3. Recovery	16.7 ± 0.9	15.8 ± 1.6	20.1 ± 1.3	11.6 ± 0.6^1-150	16.8 ± 1.4	F(4,62) = 5.16, P < .005
LMA (counts/h)	1. Baseline	83.4 ± 0.0	83.4 ± 0.0	83.3 ± 0.0	83.4 ± 0.0	83.4 ± 0.0
	2. Treatment	68.2 ± 3.5	76.7 ± 8.4	84.4 ± 4.9	141.4 ± 9.2^1-150	184.5 ± 13.9^1-150	F(4,64) = 34.79, P < .001
	3. Recovery	84.0 ± 3.9	77.7 ± 4.0	87.3 ± 3.0	60.6 ± 4.3^1-150	74.3 ± 5.4	F(4,64) = 4.72, P < .005
LMAI (LMA counts/min WAKE)	1. Baseline	2.5 ± 0.0	2.5 ± 0.1	2.6 ± 0.1	2.7 ± 0.0	2.6 ± 0.1
LMAI (LMA counts/min WAKE)	2. Treatment	2.2 ± 0.1	2.7 ± 0.2	2.5 ± 0.2	3.2 ± 0.2^1-150	3.1 ± 0.2^1-150	F(4,53) = 5.61, P < .001
	3. Recovery	2.3 ± 0.1	2.4 ± 0.1	2.7 ± 0.2	2.6 ± 0.1	2.9 ± 0.2^1-150	F(4,53) = 3.24, P < .05
DRINK (counts/h)	1. Baseline	4.2 ± 0.0	4.2 ± 0.0	4.2 ± 0.0	4.2 ± 0.0	4.2 ± 0.0
	2. Treatment	1.6 ± 0.4	2.4 ± 0.6	1.9 ± 0.4	5.2 ± 1.4^1-150	3.4 ± 1.4	F(4,67) = 3.22, P < .05
	3. Recovery	3.7 ± 0.5	5.4 ± 1.1	4.6 ± 0.5	2.5 ± 0.2	3.1 ± 0.7
Tb (°C deviation from mean)	1. Baseline	0.00 ± 0.00	0.00 ± 0.00	0.00 ± 0.00	0.00 ± 0.00	0.00 ± 0.00
Tb (°C deviation from mean)	2. Treatment	−0.11 ± 0.03	0.01 ± 0.06	0.00 ± 0.05	0.53 ± 0.13^1-150	0.43 ± 0.09^1-150	F(4,62) = 17.86, P < .001
	3. Recovery	0.08 ± 0.02	0.17 ± 0.04	0.05 ± 0.07	−0.17 ± 0.06^1-150	0.02 ± 0.05	F(4,63) = 6.76, P < .001

↵1-a Data were analyzed in time blocks as follows: Baseline, 24-h period preceding treatment; Treatment, 1–4 h post-treatment; Recovery, 5–10 h post-treatment (see “Methods” for details).
↵1-150 P < .05 vs. vehicle (Dunnett’s contrasts).