TABLE 4.
Statistical analysis of SPR719 dose proportionality in the SAD phase (fasted)a
| Parameter | Geometric LS mean |
Slope (95% CI) | |||||
|---|---|---|---|---|---|---|---|
| 100 mg (n = 6) | 250 mg (n = 6) | 500 mg (n = 6) | 1,000 mg, fasted (n = 6) | 1,500 mg (n = 6) | 2,000 mg (n = 6) | ||
| Cmax (ng/ml) | 278 | 1,220 | 2,860 | 4,730 | 5,990 | 8,240 | 1.08 (0.93–1.23) |
| AUClast (h ⋅ ng/ml) | 1,360 | 6,060 | 16,000 | 56,500 | 75,700 | 111,000 | 1.48 (1.33–1.64) |
| AUCinf (h ⋅ ng/ml) | 1,650 | 6,940 | 21,600 | 56,800 | 81,600 | 112,000 | 1.40 (1.22–1.58) |
a
Results for Cmax and AUC were obtained using a regression analysis on log-transformed values versus log-transformed dose using the power model (including an additional term for fed/fasted status for the model incorporating all cohorts for part 2). AUCinf, area under the concentration-time curve (AUC) extrapolated to infinity; AUClast, AUC from time of dosing to time of the last measurable concentration; CI, confidence interval; Cmax, maximum plasma concentration.