Table 2.
Dosing sequence A N = 5 |
Dosing sequence B N = 5 |
Dosing Sequence C N = 5 |
Overall total N = 15 |
|
---|---|---|---|---|
Characteristics | ||||
Sex, n (%) | ||||
Male | 5 (100.0%) | 1 (20.0%) | 2 (40.0%) | 8 (53.3%) |
Female | 0 | 4 (80.0%) | 3 (60.0%) | 7 (46.7%) |
Age (years) | ||||
Mean | 37.2 | 29.2 | 35.0 | 33.8 |
SD | 7.5 | 5.8 | 3.9 | 6.5 |
Race, n (%) | ||||
American Indian or Alaska Native | 0 | 0 | 0 | 0 |
Black or African American | 2 (40.0%) | 3 (60.0%) | 3 (60.0%) | 8 (53.3%) |
Asian | 0 | 0 | 0 | 0 |
Native Hawaiian or other Pacific Islander | 0 | 0 | 0 | 0 |
White | 1 (20.0%) | 2 (40.0%) | 2 (40.0%) | 5 (33.3%) |
More than one race | 1 (20.0%) | 0 | 0 | 1 ( 6.7%) |
Missing | 1 (20.0%) | 0 | 0 | 1 ( 6.7%) |
Ethnicity, n (%) | ||||
Hispanic or Latino | 1 (20.0%) | 0 | 1 (20.0%) | 2 (13.3%) |
Not Hispanic or Latino | 4 (80.0%) | 5(100.0%) | 4 (80.0%) | 13 (86.7%) |
Not reported | 0 | 0 | 0 | 0 |
Baseline Weight (kg) | ||||
Mean | 72.8 | 77.7 | 89.1 | 79.8 |
SD | 13.7 | 13.9 | 14.7 | 14.8 |
Baseline Height (cm) | ||||
Mean | 169.5 | 169.1 | 161.9 | 166.9 |
SD | 5.7 | 5.7 | 10.1 | 7.8 |
BMI (kg/m2) | ||||
Mean | 25.3 | 27.4 | 34.0 | 28.9 |
SD | 4.2 | 6.3 | 4.6 | 6.1 |
Screening xerostomia assessment—difficulty swallowing (0–10) | ||||
Mean | 0.0 | 0.0 | 0.0 | 0.0 |
SD | 0.0 | 0.0 | 0.0 | 0.0 |
Screening xerostomia assessment—dryness of lips(0–10) | ||||
Mean | 0.4 | 1.6 | 0.2 | 0.7 |
SD | 0.5 | 2.1 | 0.4 | 1.3 |
Screening xerostomia assessment—dryness of tongue (0–10) | ||||
Mean | 0.0 | 0.0 | 0.0 | 0.0 |
SD | 0.0 | 0.0 | 0.0 | 0.0 |
BMI, body mass index; SD, standard deviation
Note: Dosing sequence A: Period 1, low-dose sublingual; Period 2, high-dose sublingual; Period 3, intravenous. Dosing sequence B: Period 1, high-dose sublingual; Period 2, intravenous; Period 3, low-dose sublingual. Dosing sequence C: Period 1, intravenous; Period 2, low-dose sublingual; Period 3, high-dose sublingual
Note: Percentages were based on the number of subjects (N) in the dosing sequence. Body mass index was calculated as weight (kg)/[height (m)2]
Note: Xerostomia scores were subject reported and based on a scale of 0 to 10, with 0 being not difficult/dry at all and 10 being very difficult/dry