Table 4.
Fidaxomicin and OP-1118 fecal pharmacokinetic parameters at Day 1 after single dose
Compound | Parameter | Japanese 100 mg | Japanese 200 mg | Caucasian 200 mg | |||
---|---|---|---|---|---|---|---|
Aelast (mg) | %Aelast (%) | Aelast (mg) | %Aelast (%) | Aelast (mg) | %Aelast (%) | ||
Fidaxomicin | n | 9 | 9 | 9 | 9 | 9 | 9 |
Mean ± SD | 28.72 ± 17.72 | 28.72 ± 17.72 | 72.66 ± 58.38 | 36.33 ± 29.19 | 77.86 ± 47.05 | 38.93 ± 23.53 | |
Median | 28.85 | 28.85 | 103.5 | 51.76 | 86.86 | 43.43 | |
Min–max | 0a–67.4 | 0a–67.4 | 0a–149 | 0a–74.7 | 0a–143 | 0a–71.3 | |
OP-1118 | n | 9 | 9 | 9 | 9 | 9 | 9 |
Mean ± SD | 23.14 ± 13.18 | 24.78 ± 14.11 | 34.64 ± 28.29 | 18.55 ± 15.15 | 43.56 ± 20.84 | 23.32 ± 11.16 | |
Median | 23.89 | 25.59 | 41.98 | 22.48 | 43.08 | 23.07 | |
Min–max | 0b–40.8 | 0b–43.7 | 0b–75.3 | 0b–40.3 | 0b–73.9 | 0b–39.6 |
Ae last cumulative amount of drug excreted in the feces from time zero to the time of last measurable concentration, LLOQ lower limit of quantification, max maximum, min minimum, SD standard deviation
aSubjects with value less than LLOQ (10 ng/mL) or missing during Days 1–5
bSubject with all values less than LLOQ (50 ng/mL) during Days 1–5