P-2031. Thorough QT/QTc Clinical Study to Evaluate the Effect of Remdesivir on Cardiac Repolarization in Healthy Participants
Abstract
Abstract Background Remdesivir (RDV) is an intravenous nucleotide prodrug approved for COVID-19 treatment. Its effect on QT interval is unknown. This Phase 1 study evaluated the effects of a supratherapeutic dose of RDV on QT interval.Figure 1. Estimated ΔΔQTcF (90% CI) between RDV and Placebo-to-match RDV. ΔΔQTcF, baseline-adjusted, placebo-matched QTcF; QTcF, QT interval corrected for heart rate using the Fridericia formula; RDV, remdesivir. Methods This study included 2 cohorts of healthy participants aged 18-55 years: an RDV dose-selection cohort (Sentinel Cohort; n=6); and a randomized, placebo- and positive-controlled (moxifloxacin), single-dose crossover cohort (Thorough QT [TQT] Cohort; n=55). The Sentinel Cohort assessed pharmacokinetics (PK) and safety of a supratherapeutic RDV dose (600 mg) and was followed by the TQT Cohort. The primary endpoint for the TQT Cohort was ΔΔQTcF: the difference between baseline-adjusted QTcF (QT corrected for heart rate [HR] using the Fridericia formula) in the RDV treatment period and baseline-adjusted QTcF in the placebo period at each postdose time point. Adverse events (AEs), laboratory abnormalities, and plasma PK were also assessed.Table 1. Plasma PK Parameters for RDV and Its Metabolites (GS-704277 and GS 441524) Following a Single Dose of RDV 600 mg. AUCinf, area under the concentration-time curve extrapolated to infinite time; AUClast, area under the concentration-time curve from dosing to last measurable concentration;…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 55 participants or records.
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