TABLE 3.
Plasma pharmacokinetic parameters for omadacycline by treatment groupa
| Parameter | Value (no. of subjects) for: |
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|---|---|---|---|---|---|---|---|---|---|
| Patients with hepatic impairment |
Healthy matched controls |
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| Mild (group 1) |
Moderate (group 2) |
Severe (group 3), 50 mg i.v. | Matched to mild (group 4) |
Matched to moderate (group 5) |
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| 100 mg i.v. | 300 mg oral | 50 mg i.v. | 150 mg oral | 100 mg i.v. | 300 mg oral | 50 mg i.v. | 150 mg oral | ||
| AUClast (ng · h/ml) | 9,734 ± 1,943 (5) | 5,839 ± 2,765 (4) | 3,542 ± 397 (6) | 3,213 ± 828 (6) | 4,484 ± 531 (5) | 10,851 ± 2,595 (6) | 6,533 ± 1,665 (6) | 4,199 ± 721 (6) | 3,162 ± 1,033 (6) |
| AUCinf (ng · h/ml) | 9,734 ± 1,943 (5) | 5,839 ± 2,765 (4) | 3,542 ± 397 (6) | 3,213 ± 828 (6) | 4,484 ± 531 (5) | 10,851 ± 2,595 (6) | 6,533 ± 1,665 (6) | 4,199 ± 721 (6) | 3,162 ± 1,033 (6) |
| Cmax (ng/ml) | 9,734 ± 1,943 (5) | 5,839 ± 2,765 (4) | 3,542 ± 397 (6) | 3,213 ± 828 (6) | 4,484 ± 531 (5) | 10,851 ± 2,595 (6) | 6,533 ± 1,665 (6) | 4,199 ± 721 (6) | 3,162 ± 1,033 (6) |
| Tmax (h)b | 9,734–1,943 (5) | 5,839–2,765 (4) | 3,542–397 (6) | 3,213–828 (6) | 4,484–531 (5) | 10,851–2,595 (6) | 6,533–1,665 (6) | 4,199–721 (6) | 3,162–1,033 (6) |
| t1/2 (h) | 9,734 ± 1,943 (5) | 5,839 ± 2,765 (4) | 3,542 ± 397 (6) | 3,213 ± 828 (6) | 4,484 ± 531 (5) | 10,851 ± 2,595 (6) | 6,533 ± 1,665 (6) | 4,199 ± 721 (6) | 3,162 ± 1,033 (6) |
| CL or CL/F (liters/h)c | 9,734 ± 1,943 (5) | 5,839 ± 2,765 (4) | 3,542 ± 397 (6) | 3,213 ± 828 (6) | 4,484 ± 531 (5) | 10,851 ± 2,595 (6) | 6,533 ± 1,665 (6) | 4,199 ± 721 (6) | 3,162 ± 1,033 (6) |
| Vz or Vz/F (liters)c | 9,734 ± 1,943 (5) | 5,839 ± 2,765 (4) | 3,542 ± 397 (6) | 3,213 ± 828 (6) | 4,484 ± 531 (5) | 10,851 ± 2,595 (6) | 6,533 ± 1,665 (6) | 4,199 ± 721 (6) | 3,162 ± 1,033 (6) |
Data are for 28 subjects. Values are the mean ± standard deviation unless otherwise stated. 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; CL, mean total body clearance following intravenous administration; CL/F, apparent total body clearance following oral administration; Cmax, maximum drug concentration; i.v., intravenous; t1/2, terminal elimination half-life; Tmax, time to reach peak concentration following drug administration; Vz, apparent volume of distribution (beta method) following i.v. administration; Vz/F, apparent volume of distribution (beta method) following oral administration.
Tmax is reported as the median (range).
CL and Vz for i.v. infusion; CL/F and Vz/F for oral administration.