TABLE 2.
Plasma pharmacokinetic parameters of omadacycline, by dose, on days 1 and 5 of dosinga
| Parameter | Value for each omadacycline dose on day: |
|||||
|---|---|---|---|---|---|---|
| 1 |
5 |
|||||
| 300 mg (n = 25) | 450 mg (n = 24) | 600 mg (n = 24) | 300 mg (n = 23) | 450 mg (n = 24) | 600 mg (n = 23) | |
| Mean AUC0–24, ng · h/ml (CV) | 6,644.8 (25.3) | 8,976.5 (26.6) | 10,020.5 (25.7) | 9,267.2 (26.8) | 13,366.7 (26.0) | 16,420.3 (27.1) |
| Mean AUClast, ng · h/ml (CV) | 6,634.2 (25.3) | 8,962.5 (26.6) | 10,004.5 (25.7) | 9,270.2 (26.8) | 13,368.3 (25.9) | 16,424.6 (27.1) |
| Mean Cmax, ng/ml (CV) | 648.8 (24.0) | 874.2 (26.6) | 954.5 (23.2) | 808.8 (25.9) | 1,077.3 (25.0) | 1,305.5 (26.6) |
| Mean Tmax, h (min, max) | 2.50 (1.50, 3.00) | 2.50 (1.50, 3.00) | 2.51 (1.00, 3.00) | 2.50 (1.00, 3.00) | 2.50 (1.50, 4.00) | 2.50 (2.00, 4.00) |
| Mean t1/2, h (CV) | 13.66b (12.5) | 13.45c (12.9) | 13.03c (11.8) | 15.49d (10.7) | 16.83c (8.1) | 16.75d (6.8) |
a
Results are for the PK population. One subject during 300-mg omadacycline dosing and 1 subject during 600-mg omadacycline dosing vomited before reaching PK steady state on day 5. These subjects met criteria for exclusion from PK analyses and are not included in the day 5 summary.
b
n = 24 (t1/2 was not estimable for 1 subject).
c
n = 23 (t1/2 was not estimable for 1 subject).
d
n = 21 (t1/2 was not estimable for 2 subjects).