Table 2.
Effect of ketoconazole on the steady-state pharmacokinetics of lersivirine (study 1)
| Lersivirine (250 mg once daily) + ketoconazole (400 mg once daily) | Lersivirine (250 mg once daily) + placebo | |||||
|---|---|---|---|---|---|---|
| Parameter (units) | Geometric mean (%CV) (n = 12) | Adjusted geometric mean (A) (n = 12) | Geometric mean (%CV) (n = 14) | Adjusted geometric mean (B) (n = 12) | Ratio of adjusted geometric means (A : B) | 90% CI |
| AUC(0,24 h) (ng ml−1 h) | 4216 (24) | 4216 | 2346 (19) | 2316 | 1.82 | 1.74, 1.91 |
| Cmax (ng ml−1) | 679 (23) | 679 | 431 (18) | 423 | 1.61 | 1.41, 1.83 |
| Cmin (ng ml−1) | 25.9 (76.5) | 25.9 | 15.0 (93.8) | 15.7 | 1.65 | 1.08, 2.52 |
| Median (range) | Median (range) | |||||
| tmax (h) | 2.0 (0.5–3.0) | 1.5a (0.5–3.0) | – | – | ||
a
n = 14.
AUC(0,24 h), area under the curve over the dosing interval; CI, confidence interval; Cmax, maximum plasma concentration; Cmin, minimum plasma concentration; CV, coefficient of variation; tmax, time for Cmax.