TABLE 4.
Geometric mean ratio for primary pharmacokinetic parameters after i.v. or oral omadacycline in patients with hepatic impairment versus healthy subjectsd
| Parameter | Geometric mean ratio (90% confidence interval) for: |
||||
|---|---|---|---|---|---|
| Group 1 (mild hepatic impairment)a
|
Group 2 (moderate hepatic impairment)b
|
Group 3 (severe hepatic impairment)c |
|||
| 100 mg i.v. | 300 mg oral | 50 mg i.v. | 150 mg oral | 50 mg i.v. | |
| AUClast (ng · h/ml) | 0.90 (0.73, 1.11) | 0.79 (0.50, 1.24) | 0.85 (0.75, 0.97) | 1.02 (0.75, 1.40) | 1.08 (0.91, 1.27) |
| AUCinf (ng · h/ml) | 0.86 (0.69, 1.07) | 0.79 (0.50, 1.24) | 0.88 (0.78, 0.99) | 1.02 (0.75, 1.40) | 1.08 (0.91, 1.27) |
| Cmax (ng/ml) | 1.42 (1.10, 1.84) | 0.96 (0.64, 1.42) | 1.02 (0.84, 1.25) | 1.24 (0.94, 1.65) | 1.08 (0.89, 1.31) |
a
Group 1, mild hepatic impairment versus matched healthy subjects.
b
Group 2, moderate hepatic impairment versus matched healthy subjects.
c
Group 3, severe hepatic impairment versus healthy subjects matched to group 2 receiving omadacycline at 50 mg i.v.
d
AUCinf, area under the concentration-time curve from time zero to infinity; AUClast, area under the concentration-time curve from time zero to the last quantifiable concentration point; Cmax, maximum drug concentration in plasma; i.v., intravenous.