Thorough QT Study: Design Features for Consideration - IIR
Thorough QT Study: Design Features for Consideration - IIR
Thorough QT Study: Design Features for Consideration - IIR
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Slide 20<br />
Single Dose <strong>Design</strong><br />
• Triple-delta<br />
Baseline Day<br />
Test Day<br />
Drug<br />
<strong>QT</strong>c<br />
<strong>QT</strong>c<br />
<strong>QT</strong>c<br />
<strong>QT</strong>c<br />
V 1<br />
V 2<br />
V 3<br />
Administer<br />
V 4<br />
((V 4<br />
-V 3<br />
) – (V 2<br />
-V 1<br />
)) – (V 8<br />
-V 7<br />
) – (V 6<br />
-V 5<br />
))<br />
Multiple baseline days may be averaged<br />
Placebo<br />
<strong>QT</strong>c<br />
<strong>QT</strong>c<br />
<strong>QT</strong>c<br />
<strong>QT</strong>c<br />
V 5 V 6<br />
V 7Administer V 8<br />
Time<br />
‣ Using V 3<br />
, V 4<br />
and V 7<br />
, V 8<br />
allow <strong>for</strong> an alternative double-delta method
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