Table 1.
Characteristics of the pharmacokinetic study population
Characteristics | Patients of the two phase I studies median [range] |
Patients of CAPAGEC median [range] |
P |
---|---|---|---|
Number of patients | 40 | 20 | |
Gender (Female/Male) | 15/25 | 12/8 | 0.098 |
Age (years) | 54.5 [30–73] | 80.5 [75–92] | 3. 10−10 |
Body weight (kg) | 68 [41–95] | 74 [48–113] | 0.055 |
Body surface area (m2) | 1.80 [1.40–2.10] | 1.82 [1.41–2] | 0.52 |
Total Bilirubin (μmol/L) | 8.8 [3–22] | 5.1 [2–13.3] | 0.001 |
ClCR (ml/min) | 71 [28–115] | 66 [23–137] | 0.13 |