Key result
Single-dose GSK2336805 has no effect on LVEF in healthy adults.
Why the study?
The effects of the hepatitis C virus NS5A inhibitor GSK2336805 on cardiac contractility in healthy adults were not previously evaluated.
Does a single 150-mg dose of GSK2336805 affect echocardiographic measures of contractility in healthy adults?
RCT
double-blind
randomized
No
Does a single 150-mg dose of GSK2336805 affect echocardiographic measures of contractility in healthy adults?
A single 150-mg dose of the hepatitis C virus NS5A inhibitor GSK2336805 does not affect cardiac contractility as measured by ejection fraction in healthy adults.
Answers are grounded in this paper and cite their sources.
Supports cardiac safety for GSK2336805 development; extends human contractility data for NS5A inhibitors.
GSK2336805 is a hepatitis C virus NS5A inhibitor in clinical development for the treatment of chronic hepatitis C virus infection. This was a single-center, randomized, double-blind, placebo-controlled, two-period crossover study in healthy adults to evaluate the effects of a single 150-mg dose of GSK2336805 on echocardiographic measures of contractility. GSK2336805 had no effect on ejection fraction, and there was no significant correlation between GSK2336805 plasma concentration and ejection fraction. (This study has been registered at Clinicaltrials.gov under registration no. NCT01424540.).
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Wilfret et al. (2013) conducted an RCT in Healthy adults. GSK2336805 vs. placebo was evaluated on echocardiographic measures of contractility (ejection fraction). A single 150-mg dose of GSK2336805 had no effect on ejection fraction in healthy adults, with no significant correlation between plasma concentration and ejection fraction.
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