Comparison of three different markers for CYP3A4 activities: 4β-hydroxycholesterol/cholesterol ratio (4β-OH cholesterol ratio), 6β-hydroxycortisol/cortisol ratio (6β-OH cortisol ratio), midazolam AUC0–16 hours, and midazolam Cmax before and after 14 days of PF-06282999 administrations with statistical analysis of the treatment effect
For each PF-06282999 dose, n = 9 subjects. The ratio-to-baseline values have been back-transformed from the log scale and the t test was used to obtain the P values.
| Markers for CYP3A4 | 125 mg Twice Daily PF-06282999 | 500 mg Twice Daily PF-06282999 | ||
|---|---|---|---|---|
| Ratio to Baseline (90% CI) | P value | Ratio to Baseline (90% CI) | P value | |
| 4β-OH cholesterol ratio | 1.03 (0.95, 1.12) | 0.4657 | 1.14 (1.06, 1.24) | 0.0145 |
| 6β-OH cortisol ratio | 1.10 (0.88, 1.39) | 0.4497 | 1.53 (1.35, 1.73) | 0.0002 |
| Midazolam AUC0–16 hours | 0.67 (0.63, 0.73) | <0.0001 | 0.44 (0.38, 0.51) | <0.0001 |
| Midazolam Cmax | 0.69 (0.55, 0.87) | 0.0158 | 0.59 (0.44, 0.79) | 0.0107 |