Table 2. Summary of dosing regimens.
Single dosing (and CIV1) | ||
---|---|---|
Cohort name | Number of subjects | Dose |
C1 | 8 | 300 mg oral |
C2 | 8 | 900 mg oral |
C3 | 8 | 1200 mg oral |
C4 | 8 | 1500mg oral |
CIV1 | 8 | 3 mg/kg intravenous single dose |
Multiple dosing (and CIV2) | ||
CM1 | 8 | 300–1200 mg oral qds for 2 to 3 days |
CM2 | 8 | 1500 mg oral (or highest tolerated dose from single dosing) qds for 2 to 3 days |
CIV2 | 8 | Depends on emerging data (5–10 mg/kg intravenous) single dose |
Additional dosing cohorts may be added depending on emerging safety data. Eight cohorts and the above dose escalations represent the maximum dose increases that would occur assuming reassuring safety data.