TABLE 1

Demographic characteristics

Overall
AV-101
Pooled
placebo
Oral imatinib 400 mg
SAD
 Participants30108
 Age, years, median (range)37.5 (19–59)34.5 (27–49)48.0 (36–58)
 Female16 (53)6 (60)1 (13)
 Race
  White14 (47)3 (30)2 (25)
  Black or African American16 (53)7 (70)6 (75)
 BMI, kg·m−2, mean (range)29.4 (18.7–34.9)28.7 (19.8–33.3)28.5 (22.0–33.9)
MAD#
 Participants268
 Age, years, median (range)40.0 (21–58)37.5 (22–53)
 Female9 (35)3 (38)
 Race
  White18 (69)4 (50)
  Black or African American7 (27)4 (50)
  American Indian or Alaska Native1 (4)0
  BMI, kg·m−2, mean (range)28.7 (18.9–34.4)27.2 (19.7–32.4)

Data are presented as n or n (%), unless otherwise stated. SAD: single ascending dose; MAD: multiple ascending dose; BMI: body mass index. #: dose given twice daily for 7 days, with only the morning dose administered on day 7.