Secondary Phenotyping Metrica | CYP | Sample Size | Units | Geometric Mean (95% CI) | |
---|---|---|---|---|---|
Placebo | Silexan | ||||
Molar paraxanthine/caffeine plasma concentration ratio 6 h post-dose | 1A2 | 16 | None | 1.09 (0.76–1.56) | 1.27 (0.93–1.73) |
Tolbutamide plasma concentration 24 h post-dose | 2C9 | 16 | μM | 6.16 (4.40–8.63) | 6.81 (4.98–9.31) |
Molar omeprazole/5-OH-omepazole plasma concentration ratio 3 h post-dose | 2C19 | 16b | None | 0.800 (0.583–1.10) | 0.820 (0.561–1.20) |
Molar omeprazole/5-OH-omepazole AUC0–t ratio CYP2C19 | 16 | None | 0.795 (0.615–1.03) | 0.884 (0.694–1.13) | |
Molar dextromethorphan/dextrorphan plasma concentration ratio 3 h post-dose | 2D6 | 15c | None | 0.263 (0.137–0.504) | 0.297 (0.149–0.592) |
Midazolam plasma concentration 6 h post-dose | 3A4 | 16 | nM | 4.07 (3.19–5.20) | 4.23 (3.25–5.52) |
AUC0–t, area under the plasma concentration-time curve between 0 and time of last quantifiable concentration.
↵a Units for concentrations of midazolam are nM, those for tolbutamide are µM.
↵b Concentration in one subject in the silexan period was below limit of quantification.
↵c One subject excluded because identified as genetically poor metabolizer.