Key result
GS-4997 did not cause QT prolongation, with the upper bound of the 90% CI for predicted placebo-corrected ΔQTcF being <10 msec at therapeutic and supratherapeutic levels.
Why the study?
Does GS-4997 cause QT prolongation in healthy subjects?
Population
Healthy subjects in a first-in-human (FIH) study
Comparison
GS-4997, single and multiple-ascending doses vs Placebo
Design
Other
Authors
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Supports waiver of dedicated TQT studies; extends concentration-QTc modeling as a robust early-phase alternative.
RCT
Does GS-4997 cause QT prolongation in healthy subjects?
Effect estimate: Upper bound of 90% CI <10 msec
A systematic modeling approach in a first-in-human study demonstrated no clinically relevant QT prolongation with GS-4997, successfully supporting a waiver for a dedicated thorough QT study.
Nelson et al. (2015) conducted an RCT in Healthy subjects. GS-4997 vs. Placebo was evaluated on Predicted placebo-corrected baseline-adjusted QTcF (ΔΔQTcF) (Upper bound of 90% CI <10 msec). GS-4997 did not cause QT prolongation, with the upper bound of the 90% CI for predicted placebo-corrected ΔQTcF being <10 msec at therapeutic and supratherapeutic levels.
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