Table 2.
Study | Phase | n a | No. of CdA samplesb | No. of CAde samplesb | Treatment: administration and dose (cumulative) | ||
---|---|---|---|---|---|---|---|
Plasma | Urine | Plasma | Urine | ||||
25803 | I | 16 | 404 | 166 | 189 | 89 | CdA: 3 mg IV infusion/10 mg single oral doses |
26127 | I | 16 | 416 | – | – | – | CdA: 10 mg single oral doses |
26486 | I | 16 | 419 | – | – | – | CdA: 1.75 mg/kg orally over 8 weeks + IFNβ-1a |
25643 | III | 125 | 470 | – | 466 | – | CdA: 3.5 or 5.25 mg/kg orally over 2 years |
PK pharmacokinetic, CdA cladribine, CAde 2-chloroadenine, IV intravenous, IFN interferon, RRMS relapsing-remitting multiple sclerosis
aNumber of CdA-treated RRMS patients included in the population PK analysis
bTotal number of samples available for the population PK analysis