Table 1.
Demographic characteristics of study participants
| PRN1008 dose regimen: PART A | ||||||||
|---|---|---|---|---|---|---|---|---|
| Parameter | Statistic | 50 mg | 150 mg | 300 mg | 600 mg | 1200 mg | Placebo | Total |
| Age (years) | ||||||||
| N | 6 | 6 | 6 | 6 | 6 | 10 | 40 | |
| Mean | 24.8 | 28.0 | 20.5 | 26.3 | 32.2 | 22.9 | 25.5 | |
| SD | 4.5 | 11.7 | 2.0 | 5.4 | 11.7 | 3.4 | 7.6 | |
| Median | 23.5 | 23.5 | 21.5 | 25.5 | 29.0 | 23.0 | 23.0 | |
| Race | ||||||||
| Caucasian | n (%) | 4 (67%) | 4 (67%) | 6 (100%) | 6 (100%) | 5 (83%) | 9 (90%) | 34 (85%) |
| Asian | n (%) | 1 (17%) | 1 (17%) | 1 (10%) | 3 (8%) | |||
| Black | n (%) | 1 (17%) | 1 (3%) | |||||
| Other: Arabic | n (%) | 1 (17%) | 1 (3%) | |||||
| Other: Eurasian | n (%) | 1 (17%) | 1 (3%) | |||||
| Sex | ||||||||
| Male | n (%) | 6 (100%) | 6 (100%) | 6 (100%) | 6 (100%) | 6 (100%) | 10 (100%) | 40 (100%) |
| Weight (kg) | ||||||||
| Mean | 74.1 | 73.1 | 80.8 | 74.0 | 86.0 | 74.1 | 76.7 | |
| SD | 9.5 | 9.4 | 8.5 | 10.7 | 12.9 | 9.6 | 10.5 | |
| Median | 76.2 | 75.4 | 78.4 | 74.0 | 79.4 | 76.3 | 77.1 | |
| BMI | ||||||||
| Mean | 22.7 | 23.1 | 24.2 | 23.5 | 26.2 | 22.5 | 23.6 | |
| SD | 2.0 | 3.3 | 1.6 | 2.6 | 3.3 | 1.7 | 2.6 | |
| Median | 23.2 | 23.5 | 23.9 | 22.8 | 25.2 | 22.1 | 23.5 | |
| PRN 1008 dose regimen: PART B | |||||||
|---|---|---|---|---|---|---|---|
| Parameter | Statistic | 300 mg QD | 300 mg BID | 600 mg QD | 450 mg BID | Placebo | Total |
| Age (years) | |||||||
| N | 8 | 8 | 8 | 8 | 8 | 40 | |
| Mean | 30.0 | 27.0 | 23.6 | 28.9 | 24.4 | 26.8 | |
| SD | 8.5 | 7.0 | 4.2 | 7.3 | 5.0 | 6.7 | |
| Median | 27.0 | 25.5 | 23.5 | 27.5 | 23.0 | 24.0 | |
| Race | |||||||
| Caucasian | n (%) | 5 (63%) | 7 (88%) | 7 (88%) | 6 (75%) | 6 (75%) | 31 (78%) |
| Asian | n (%) | 2 (25%) | 1 (13%) | 1 (13%) | 1 (13%) | 5 (13%) | |
| Black | n (%) | 1 (13%) | 1 (13%) | 1 (13%) | 3 (8%) | ||
| Other: Eurasian | n (%) | 1 (13%) | 1 (3%) | ||||
| Sex | |||||||
| Male | n (%) | 8 (100%) | 8 (100%) | 8 (100%) | 8 (100%) | 8 (100%) | 40 (100%) |
| Weight (kg) | |||||||
| Mean | 76.0 | 75.3 | 87.0 | 86.0 | 75.5 | 79.9 | |
| SD | 10.2 | 12.3 | 15.2 | 12.7 | 10.3 | 12.8 | |
| Median | 75.6 | 72.8 | 88.1 | 91.4 | 75.7 | 76.9 | |
| BMI | |||||||
| Mean | 25.1 | 23.8 | 25.0 | 25.6 | 23.4 | 24.6 | |
| SD | 2.4 | 4.0 | 3.4 | 3.1 | 2.3 | 3.1 | |
| Median | 25.3 | 21.8 | 24.3 | 26.7 | 23.2 | 24.1 | |
SD, standard deviation; BMI, body mass index; QD = every 24 h; BID = every 12 h