Use of Early Clinical Trial Data to Support Thorough QT Study Waiver for Upadacitinib and Utility of Food Effect to Demonstrate ECG Assay Sensitivity

Figures

• 

  Figure 1. Relationship between (a) observed change from baseline in ΔQTcF in the single‐ and multiple‐dose phase I studies vs. upadacitinib plasma concentrations, and (b) model‐predicted mean drug effect with two‐sided 90% CI across the range of observed individual upadacitinib plasma concentrations. [Color figure can be viewed at http://wileyonlinelibrary.com]

• 

  Figure 2. Schematic of the ECG timepoints and meals in the single‐ascending dose (SAD) and multiple‐ascending dose (MAD) studies prior to dosing and in the first 2 h after dosing. [Color figure can be viewed at http://wileyonlinelibrary.com]

• 

  Figure 3. Assessment of bias in QTcF measurements. Bland–Altman plot for the full analysis set comparing the semiautomated and fully‐automated QTcF measurements. Footnote: Red solid and dotted lines represent mean ± 2 standard deviations of the difference between the two measurement methods; green dashed line represents regression through the data using an M estimator as described by Ferber et al.22 [Color figure can be viewed at http://wileyonlinelibrary.com]