Summary of trial simulation design
| Simulated Pop | Observed Pop | Dosing Regimen | PK Measurement of Substrate | |
|---|---|---|---|---|
| Model performance of midostaurin PK and ketoconazole DDIs | Healthy volunteer | Healthy volunteer | Ketoconazole 400 mg daily on days 1–10 + midostaurin (FMI) 50 mg on day 6 | 0–120 h, 0–inf |
| Model performance of midostaurin PK and rifampicin DDIs | Healthy volunteer | Healthy volunteer | Rifampicin 600 mg daily on days 1–14 + midostaurin (FMI) 50 mg on day 9 | 0–144 h, 0–inf |
| Model performance of midazolam PK and midostaurin-midazolam DDIs | Healthy volunteer | Healthy volunteer | Midazolam 4 mg daily on days 1 and 6 + midostaurin 100-mg single dose on day 1, 50 mg twice daily on days 2–4 | Day 1: 0–10 h, 0-inf Day 6: 0–10 h |