Table 3.
Comparison of Pharmacokinetic Parameters in Part A and Part B Participants
| Pharmacokinetics Parameter | Part A (n = 12) | Part B (n = 11) | |||
|---|---|---|---|---|---|
| Mean (± SD) | % CV | Mean (± SD) | % CV | ||
| Day 1 | Cmin (ng/mL) | 35.83 (± 37.28) | 323 | 74.74 (± 24.51) | 46 |
| Cmax (ng/mL) | 97.55 (± 117.9) | 195 | 193.3 (± 93.50) | 58 | |
| Tmax (h) | 19.73 (± 5.67) | – | 14.776 (± 7.537) | – | |
| AUC0-24 (ng × h/mL) | 1364.0 (± 1754.0) | 219 | 2851.0 (± 1256.0) | 50 | |
| Day 5 | Cmin (ng/mL) | 258.8 (± 353.1) | 187 | 455.8 (± 221.5) | 47 |
| Cmax (ng/mL) | 280.7 (± 355.2) | 173 | 514.1 (± 202.0) | 39 | |
| Tmax (h) | 9.679 (± 10.81) | – | 6.683 (± 3.765) | – | |
| AUC0-24 (ng × h/mL) | 6863.0 (± 8552.0) | 172 | 11 298.0 (± 5580.0) | 59 | |
| Summary | t1/2 (h)a | 336.5 (± 84.71) | 25 | 535.5 (± 4.950) | 1 |
| RAUC | 5.905 (± 3.516) | 57 | 4.111 (± 1.579) | 50 |
Abbreviations: AUC, area under the curve; Cmax, peak plasma concentration; Cmin, trough plasma concentration; CV, coefficient of variation; RAUC, accumulation ratio for AUC0-24 for day 5 to day 1; SD, standard deviation; t1/2, elimination half-life; Tmax, time to reach Cmax.
aElimination half-life of clofazimine was previously found to be ≤70 days upon repeat dose administration; therefore, the relatively short plasma sampling schedule in this study may not accurately capture the t1/2 parameter in these populations.