Overall AV-101 | Pooled placebo | Oral imatinib 400 mg | |
SAD | |||
Participants | 30 | 10 | 8 |
Age, years, median (range) | 37.5 (19–59) | 34.5 (27–49) | 48.0 (36–58) |
Female | 16 (53) | 6 (60) | 1 (13) |
Race | |||
White | 14 (47) | 3 (30) | 2 (25) |
Black or African American | 16 (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# | |||
Participants | 26 | 8 | |
Age, years, median (range) | 40.0 (21–58) | 37.5 (22–53) | |
Female | 9 (35) | 3 (38) | |
Race | |||
White | 18 (69) | 4 (50) | |
Black or African American | 7 (27) | 4 (50) | |
American Indian or Alaska Native | 1 (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.