TABLE 3.
Secondary PK metrics summary using noncompartmental analysis (carryover not adjusted for).
| Whole | Disp | Whole | Disp | Whole | Disp | |
|---|---|---|---|---|---|---|
| 25 mg (n = 16) | 25 mg (n = 17) | 50 mg (n = 16) | 50 mg (n = 17) | 100 mg (n = 16) | 100 mg (n = 16) | |
| Delamanid | ||||||
| T max (h) | 3.81 (1.77, 5.87) | 3.88 (1.77, 5.93) | 3.86 (2.10, 5.90) | 3.87 (1.80, 5.88) | 3.82 (1.82, 5.93) | 3.97 (3.75, 6.07) |
| C max (ng/mL) | 136 (86.4, 193) | 106 (66.9, 169) | 192 (119, 290) | 208 (106, 241) | 233 (112, 424) | 224 (126, 442) |
| AUC0‐48 (ng·h/mL) | 1522 (1076, 2065) | 1468 (870, 2097) | 2346 (1525, 3710) | 2602 (1508, 3683) | 3488 (1994, 4746) | 3809 (2312, 4789) |
| DM‐6705 | ||||||
| T max (h) | 5.84 (3.77, 48.4) | 7.88 (3.8, 48.3) | 5.87 (2.10, 47.1) | 5.88 (3.75, 47.9) | 7.82 (3.77, 48.7) | 23.4 b (3.75, 48.3) |
| C max (ng/mL) | 2.5 (1.2, 5.3) | 2.8 (1.2, 5.3) | 3.3 (1.3, 7.1) | 2.8 (1.9, 9.5) | 4.5 (3.2, 6.7) | 5.2 (2.6, 8.1) |
| AUC0‐48 (ng·h/mL) | 105 (50, 222) | 106 a (50, 221) | 136 (55, 312) | 122 (75, 359) | 184 (113, 300) | 187 (98, 359) |
Note: PK metrics are summarized as median (minimum, maximum).
Abbreviations: Disp, delamanid dispersed; Whole, delamanid whole tablet(s).
a
The AUC minimum of 50 was reported after excluding an incomplete PK profile (<5 h).
b
Seven participants had T max above 40 h; seven were less than 10 h; two were around 24 h, contributing to the median of 23.4 h.