Table 1.
Relevant PK parameters by treatment group.
| Treatment | Subject | Cmax [ng/mL] | AUC inf [h·ng/mL] | Time > LD50 [h] | AUC > LD50 [h·g/mL] |
|---|---|---|---|---|---|
| Ivermectin 1 | 69 | 14.3 | 1916.2 | 46.7 | 509.4 |
| 70 | 24.1 | 694.9 | 27.2 | 198.9 | |
| 71 | 3.0 | 16.9 | 0.0 | 0.0 | |
| 72 | 1.6 | — | 0.0 | — | |
| 73 | 27.6 | 244.3 | 9.3 | 47.3 | |
| 74 | 2.9 | 99.4 | 0.0 | 0.0 | |
| Median (Range) | 8.7 (26.0) | 244 (1899) | 4.6 (46.7) | 23.7 (509.4) | |
| Ivermectin 2 | 73.2 | 15.2 | 1380.0 | 54.5 | 226.3 |
| 75 | 20.9 | 1030.5 | 45.4 | 368.9 | |
| Median (Range) | 18 (5.6) | 1205.3 (349) | 49.9 (9.1) | 297.6 (142.6) | |
| Ivermectin(combined) | 69 | 14.3 | 1916.2 | 46.7 | 509.4 |
| 70 | 24.1 | 694.9 | 27.2 | 198.9 | |
| 71 | 3.0 | 16.9 | 0.0 | 0.0 | |
| 73.2 | 15.2 | 1380.0 | 54.5 | 226.3 | |
| 74 | 2.9 | 99.4 | 0.0 | 0.0 | |
| 75 | 20.9 | 1030.5 | 45.4 | 368.9 | |
| Median (Range) | 14.8* (21) | 862.7 (1899) | 36.3* (54) | 212.6* (509) | |
| Ivermectin + ketoconazole | 69 | 27.7 | 2320.7 | 117.1 | 703.9 |
| 72 | 28.4 | 1863.3 | 104.6 | 718.5 | |
| Median (Range) | 28.0* (0.7) | 2092 (457.4) | 110.8* (12.4) | 711.2* (14.6) | |
| Ivermectin + rifampin | 71 | 0.3 | — | 0.0 | 0.0 |
| 74 | 6.8 | — | 4.7 | — | |
| Median (Range) | 3.6 (6.5) | — | 2.4 (4.7) | — |
Footnote: Cmax: peak plasma concentration, AUC inf: area under the PK curve to infinity, LD50: the 10-day lethal concentration 50 of ivermectin for Anopheles gambiae (6 ng/ml). Pig 72 died and was replaced by pig 75. Pig 73 received ivermectin in phase 1 and was randomised to ivermectin alone in phase 2, this is denoted as 73/73.2, these observations were not combined in order to sustain sample independence. *Denotes a statistically significant difference.