TABLE 6.
Statistical analysis of dose proportionality for EC5026 based on SAD study.
| Dose range | Parameter (units) | Estimated slope | Standard error of the slope | 90% CI of the slope | Dose proportionality criteria |
|---|---|---|---|---|---|
| 2–24 mg | C max (ng/mL) | 1.69 | 0.080 | (1.55, 1.83) | (0.91, 1.09) |
| AUC0–t (ng•h/mL) | 1.43 | 0.131 | (1.20, 1.65) | (0.91, 1.09) | |
| AUC0–48 (ng•h/mL) | 1.59 | 0.084 | (1.45, 1.74) | (0.91, 1.09) | |
| 8–24 mg | C max (ng/mL) | 1.20 | 0.082 | (1.06, 1.35) | (0.80, 1.20) |
| AUC0–t (ng•h/mL) | 0.89 | 0.124 | (0.67, 1.10) | (0.80, 1.20) | |
| AUC0–48 (ng•h/mL) | 1.10 | 0.069 | (0.98, 1.22) | (0.80, 1.20) | |
| AUC0–inf (ng•h/mL) | 0.85 | 0.116 | (0.65, 1.05) | (0.80, 1.20) |
Note: Subjects were excluded from the PK population when there were fewer than 3 quantifiable plasma samples. Values for AUC0–inf were excluded from summary statistics when %AUCextrap was >20%. The power model, ln(parameter) = intercept + slope × ln(dose), was used to estimate the slope and corresponding 90% CI. Dose proportionality was concluded if the 90% CI of the slope (β) lies entirely within [1 + ln(0.8)/ln(r), 1 + ln(1.25)/ln(r)], where r is the dose range (highest dose/lowest dose).