TABLE 3.
Pharmacokinetic data for subjects experiencing grade 2 adverse events
| Subject | Dose (mg) | Dose (mg/kg)a | Dose range (mg/kg) for cohort | Grade 2 adverse event | Cmax (ng/ml) | AUC (ng · h/ml) | Mean AUC (ng · h/ml) for cohort | AUC range (ng · h/ml) for cohort |
|---|---|---|---|---|---|---|---|---|
| 206 | 400 | 4.7∗ | 4.3–6.1 | Abdominal painb | 1,186 | 4,305 | 9,570 | 1,761–14,858 |
| 212 | 400 | 6.0† | 4.3–6.1 | Dizziness | 1,117 | 11,173 | 9,570 | 1,761–14,858 |
| 212 | 400 | 6.0† | 4.3–6.1 | Nausea | 1,117 | 11,173 | 9,570 | 1,761–14,858 |
| 212 | 400 | 6.0† | 4.3–6.1 | Vomiting (gagging, no emesis) | 1,117 | 11,173 | 9,570 | 1,761–14,858 |
| 306 | 600 | 9.0† | 7.3–10.8 | Dizziness | 2,308 | 10,445 | 12,973 | 1,840–15,328 |
| 311 | 600 | 7.5∗ | 7.3–10.8 | Arthralgia and arthritisb | 325 | 1,840 | 12,973 | 1,840–15,328 |
| 314 | 600 | 8.5∗ | 7.3–10.8 | Hypertensionb | 1,370 | 8,247 | 12,973 | 1,840–15,328 |
| 315 | 600 | 10.8† | 7.3–10.8 | Pharyngitisb | 3,443 | 14,746 | 12,973 | 1,840–15,328 |
∗, subject was fed prior to dosing; †, subject was fasted prior to dosing.
Considered by investigator to be unrelated to dosing.