TABLE 1.

Study design

Regimen and cohorta	Dosing schedule
Single-dose escalation
A	50 mg for period 1; 800 mg for period 2
B	200 mg for period 1; 1,200 mg for period 2
C	400 mg for period 1; 400 mg + food for period 2
Repeat-dose escalation
D	200 mg on day 1; 200 mg BID on days 2 to 8
E	400 mg on day 1; 400 mg BID on days 2 to 8
F	600 mg on day 1; 600 mg BID on days 2 to 8
G	800 mg on day 1; 800 mg BID on days 2 to 8

^aFor each cohort, n = 10 (8 active and 2 placebo).