Table 4.

Summary of core body temperature parameters

	Cohort 1		Cohort 2		Cohort 3
	n = 12		n = 12		n = 12
	1 mg twice daily		2.5 mg twice daily		5 mg twice daily
Parameter†	XEN-D0501	Placebo	XEN-D0501	Placebo	XEN-D0501	Placebo
AUEC(0,12 h) (°C h)
Day 1
n	11	10	11	11	10	10
Mean	447	443	450	445	453	444
SD	2.1	2.0	2.4	1.5	3.7	1.5
Min, max	444, 451	440, 447	447, 454	442, 446	446, 461	440, 446
Day 2
n	7	11	8	11	10	9
Mean	450	445	450	444	450	444
SD	4.8	1.0	1.6	1.5	2.5	1.3
Min, max	446, 460	444, 446	448, 452	442, 447	447, 456	442, 446
Day 7
n	8	9	11	10	11	8
Mean	446	446	448	446	448	444
SD	1.4	1.8	2.1	1.4	1.7	2.0
Min, max	444, 448	444, 450	444, 452	443, 448	446, 451	440, 447
Day 14
n	10	9	10	11	10	10
Mean	447	445	448	445	447	444
SD	1.6	1.9	1.8	1.9	2.1	1.4
Min, max	444, 449	443, 448	445, 451	441, 447	443, 450	441, 446
Maximum temperature (°C)
Day 1
n	11	10	11	11	10	10
Mean	37.64	37.42	37.90	37.40	38.16	37.42
SD	0.21	0.13	0.19	0.14	0.32	0.16
Min, max	37.23, 37.98	37.21, 37.58	37.66, 38.16	37.06, 37.55	37.60, 38.82	37.16, 37.73
Day 2
n	7	11	8	11	10	9
Mean	37.95	37.44	37.91	37.43	37.91	37.46
SD	0.51	0.13	0.23	0.15	0.27	0.19
Min, max	37.61, 39.07	37.23, 37.70	37.59, 38.27	37.24, 37.71	37.58, 38.49	37.16, 37.72
Day 7
n	8	9	11	10	11	8
Mean	37.54	37.60	37.77	37.56	37.74	37.45
SD	0.18	0.14	0.29	0.21	0.18	0.22
Min, max	37.29, 37.85	37.40, 37.90	37.46, 38.35	37.24, 37.88	37.44, 38.13	37.19, 37.82
Day 14
n	10	9	10	11	10	10
Mean	37.59	37.44	37.70	37.59	37.69	37.39
SD	0.20	0.23	0.26	0.25	0.25	0.18
Min, max	37.32, 37.90	37.21, 37.91	37.43, 38.12	37.13, 37.99	37.23, 38.03	37.03, 37.64

^†Measured over the 0–12 h after the morning dose of XEN-D0501 or placebo.