Decitabine AUC for oral cedazuridine/decitabine vs IV decitabine
| Parameter . | IV geometric LSM . | Oral geometric LSM . | LSM ratio (oral/IV) . | 80% CI . | Intrapatient CV% . |
|---|---|---|---|---|---|
| Primary paired population | |||||
| 5-d AUClast, ng × hr per mL (primary end point) | |||||
| DC cohort (n = 40) | 802.81 | 750.82 | 93.52 | 82.10-106.5 | 47.0 |
| FDC cohort (n = 24) | 745.26 | 727.29 | 97.59 | 80.48-118.3 | 53.8 |
| Secondary unpaired population | |||||
| 5-d AUClast, ng × hr per mL | |||||
| DC cohort | 795.41 (n = 42) | 735.62 (n = 48) | 92.48 | 81.37-105.1 | 48.4 |
| FDC cohort | 742.26 (n = 26) | 760.43 (n = 28) | 102.45 | 85.35-123.0 | 52.7 |
| 5-d AUC24, h/ng per mL | |||||
| DC cohort | 794.73 (n = 40) | 753.68 (n = 45) | 94.83 | 83.97-107.1 | 43.5 |
| FDC cohort | 696.90 (n = 20) | 846.82 (n = 26) | 121.51 | 97.15-152.0 | 59.1 |
| 5-d AUC∞, ng × hr per mL | |||||
| DC cohort | 794.73 (n = 40) | 733.26 (n = 42) | 92.27 | 81.27-104.7 | 44.6 |
| FDC cohort | 687.08 (n = 40) | 845.57 (n = 26) | 121.30 | 97.00-151.7 | 59.1 |
| Parameter . | IV geometric LSM . | Oral geometric LSM . | LSM ratio (oral/IV) . | 80% CI . | Intrapatient CV% . |
|---|---|---|---|---|---|
| Primary paired population | |||||
| 5-d AUClast, ng × hr per mL (primary end point) | |||||
| DC cohort (n = 40) | 802.81 | 750.82 | 93.52 | 82.10-106.5 | 47.0 |
| FDC cohort (n = 24) | 745.26 | 727.29 | 97.59 | 80.48-118.3 | 53.8 |
| Secondary unpaired population | |||||
| 5-d AUClast, ng × hr per mL | |||||
| DC cohort | 795.41 (n = 42) | 735.62 (n = 48) | 92.48 | 81.37-105.1 | 48.4 |
| FDC cohort | 742.26 (n = 26) | 760.43 (n = 28) | 102.45 | 85.35-123.0 | 52.7 |
| 5-d AUC24, h/ng per mL | |||||
| DC cohort | 794.73 (n = 40) | 753.68 (n = 45) | 94.83 | 83.97-107.1 | 43.5 |
| FDC cohort | 696.90 (n = 20) | 846.82 (n = 26) | 121.51 | 97.15-152.0 | 59.1 |
| 5-d AUC∞, ng × hr per mL | |||||
| DC cohort | 794.73 (n = 40) | 733.26 (n = 42) | 92.27 | 81.27-104.7 | 44.6 |
| FDC cohort | 687.08 (n = 40) | 845.57 (n = 26) | 121.30 | 97.00-151.7 | 59.1 |
AUC24, AUC from time 0 to 24 h; AUC∞, AUC from time 0 to ∞; CV, coefficient of variation; DC, dose confirmation (2 separate capsules of cedazuridine and decitabine); FDC, fixed dose combination.