Table 1.

Designs and dose regimens of ABT-288 healthy young adults and elderly studies

Study	Treatment group	N	Treatment
			Period 1		Period 2		Period 3		Period 4
Young adults Part 1 (single dose escalation)	1	3	0.1 mg		1 mg		Placebo		40 mg
		3	0.1 mg		Placebo		10 mg		40 mg
		3	Placebo		1 mg		10 mg		Placebo
	2	3		0.3 mg		3 mg		Placebo		NE
		3		0.3 mg		Placebo		20 mg		NE
		3		Placebo		3 mg		20 mg		NE
Young adults Part 2 (food effect)	3	6	5 mg fasting		5 mg non-fasting
		6	5 mg non-fasting		5 mg fasting
Young adults Part 3 (multiple dose escalation)	4	9	0.5 mg once-daily for 14 days
		3	Placebo
	5	9	3 mg once-daily for 14 days
		3	Placebo
	6	9	6 mg once-daily for 14 days*
		3	Placebo
	7	9	1.5 mg once-daily for 14 days
		3	Placebo
Elderly subjects (multiple dose escalation)	1	6	0.5 mg once-daily for 12 days
		6	1.5 mg once-daily for 12 days
		4	Placebo
	2	6	3 mg once-daily for 12 days
		2	Placebo
	3†	6	5 mg once-daily for 12 days
		2	Placebo

^*Dosing with 6 mg once-daily was stopped on day 6 due to intolerance;

^†only five subjects enrolled in this dose group and they all received ABT-288; NE, not evaluated. Non-fasting: with a high fat/high calorie breakfast.