TABLE 3

Assessment of the effect of silexan on phenotyping metrics given as ratios for silexan over placebo periods

CYPParameteraSample SizeRatio90% CICVintra%
1A2AUC0–t of caffeine in plasma160.8690.786–0.96116.2
Molar paraxanthine / caffeine plasma concentration ratio 6 h post-dose161.160.956–1.41432.2
2C9AUC0–t of tolbutamide in plasma161.0350.973–1.10110.0
Tolbutamide plasma concentration 24 h post-dose161.1060.970–1.26121.3
2C19AUC0–t of omeprazole in plasma161.1430.810–1.61459.9
Molar omeprazole / 5-OH-omepazole plasma concentration ratio 3 h post-dose15b1.0440.842–1.29434.3
Molar omeprazole / 5-OH-omepazole AUC0–t ratio161.1110.998–1.23717.4
2D6AUC0–t of dextromethorphan in plasma15c1.0460.838–1.30536.7
Molar dextromethorphan / dextrorphan plasma concentration ratio 3 h post-dose15c1.1310.962–1.32825.2
3A4AUC0–t of midazolam in plasma161.0180.894–1.15921.1
Midazolam plasma concentration 6 h post-dose161.0400.847–1.27733.8
  • AUC0–t, area under the plasma concentration-time curve between 0 and time of last quantifiable concentration; CI, confidence interval; CVintra, intrasubject coefficient of variation.

  • a The main phenotyping metrics are printed in bold.

  • b Concentration in one subject in the silexan period was below limit of quantification.

  • c One subject excluded because identified as genetically poor metabolizer.