Table 3.
Observed remdesivir and Nuc PK parameters in plasma (Cmax, drug exposure, AUC, and half‐life) were calculated using EMA compassionate use of remdesivir PK data
| PK Parameter | Observed a | Simulated | Fold change b |
|---|---|---|---|
| Remdesivir day 1 (N = 8) | |||
| Cmax (ng/mL) | 5440 (20.3) | 1300 | 0.24 |
| AUC c (h∙ng/mL) | 2920 (20.6) | 3064 | 1.1 |
| t1/2 (h) | 0.98 (0.82, 1.03) | 2.6 | 2.6 |
| Remdesivir day 5 (N = 7) | |||
| Cmax (ng/mL) | 2610 (12.7) | 653 | 0.25 |
| AUC c (h∙ng/mL) | 1560 (13.9) | 2600 | 1.7 |
| t1/2 (h) | 0.89 (0.82, 1.09) | 2.6 | 2.9 |
| Nuc day 1 (N = 8) | |||
| Cmax (ng/mL) | 152 (25.9) | 169 | 1.1 |
| AUC c (h∙ng/mL) | 2240 (29.1) | 3060 | 1.4 |
| t1/2 (h) | NA | 23.1 | NA |
| Nuc day 5 (N = 7) | |||
| Cmax (ng/mL) | 142 (30.3) | 162 | 1.1 |
| AUC c (h∙ng/mL) | 2230 (30.0) | 3230 | 1.4 |
| t1/2 (h) | 25.3 (24.10, 30.32) | 23.1 | 0.9 |
Simulated remdesivir and Nuc PK parameters in plasma were calculated based on PK profiles simulated using allometrically scaled human PK parameters. Currently approved treatment simulated was 30‐minute i.v. infusion of 200 mg of remdesivir on day 1 followed by 100 mg daily for 4 days in healthy subjects. The difference between the observed and simulated parameters (Fold Change) is reported here.
Abbreviations: %CV, percent coefficient of variation; AUC, area under the curve; Cmax, peak concentration; EMA, European Medicines Agency; Nuc, GS‐441524; PK, pharmacokinetic; t1/2, half‐life.
Observed PK parameters are presented as mean (%CV), whereas the t1/2 as median (Q1, Q3).
Fold‐change was calculated as the ratio of the simulated parameter to the observed parameter.
Area under the curve for day 1 (AUC0–24) and for day 5 (AUCτ).