TABLE 2.
Summary of gepotidacin plasma PK parameters (PK parameter population) (N = 22)a
| PK parameter and time pointb | Value for the parameterc
|
|
|---|---|---|
| Geometric mean (% CVb) | Min–max | |
| Cmax (μg/ml) | ||
| Day 1 | 5.89 (47.3) | 1.82–12.8 |
| Day 2 | ||
| Day 3 | ||
| Day 4 | 8.44 (38.0) | 3.82–16.8 |
| Day 5 | ||
| Tmax (h) | ||
| Day 1 | 1.50d | 0.470–3.07 |
| Day 2 | ||
| Day 3 | ||
| Day 4 | 1.92d | 0.450–4.12 |
| Day 5 | ||
| AUC0-τ (μg·h/ml) | ||
| Day 1 | 20.2 (28.6) | 11.0–31.0 |
| Day 2 | ||
| Day 3 | ||
| Day 4 | 29.3 (31.8) | 15.2–49.5 |
| Day 5 | ||
| CLss/F (l/h) | ||
| Day 1 | ||
| Day 2 | ||
| Day 3 | ||
| Day 4 | 51.2 (31.8) | 30.3–98.7 |
| Day 5 | ||
| Ro | ||
| Day 1 | ||
| Day 2 | ||
| Day 3 | ||
| Day 4 | 1.40 (20.4) | 1.09–2.20 |
| Day 5 | ||
| Cτ (μg/ml) | ||
| Day 1 | ||
| Day 2 | 0.621 (62.3) | 0.122–1.84 |
| Day 3 | 0.789 (37.4) | 0.371–1.60 |
| Day 4 | 0.851 (41.4) | 0.460–1.99 |
| Day 5 | 0.819 (46.4) | 0.327–1.93 |
a
N, number of participants in the treatment.
b
Cmax, maximum observed concentration; Tmax, time of occurrence of Cmax; AUC0-τ, area under the concentration-time curve from time zero to the 12-h dosing interval; CLss/F, apparent steady-state clearance; Ro, accumulation ratio based on the AUC0-τ; Cτ, predose concentration. The numbers of participants with evaluable PK parameter data were 20 for day 1 and 21 for days 2 to 5, with the exception that day 4 Ro data are for 19 participants.
c
CVb, between-participant geometric coefficient of variation; max, maximum; min, minimum.
d
Values are medians.