The purpose of the study is to assess the effect of a therapeutic and supratherapeutic dose of zelicapavir on the corrected cardiac QT interval relative to a placebo and positive control in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
72
Subjects will receive zelicapavir (TD) once per treatment period.
Subjects will receive zelicapavir (SD) once per treatment period.
Subjects will receive zelicapavir matching placebo once per treatment period.
ICON
Lenexa, Kansas, United States
ICON Early Phase, LLC
San Antonio, Texas, United States
Time-matched, placebo-corrected change-from-baseline QTc based on the Fridericia correction QTcF (ΔΔQTcF) after TD and SD of Zelicapavir
Time frame: Up to 24 hours post dose
Time-matched, placebo-corrected, change-from-baseline non-QT intervals after TD and SD of Zelicapavir
Time frame: Up to 24 hours post dose
Time-matched, placebo-corrected, change-from-baseline HR after TD and SD of Zelicapavir
Time frame: Up to 24 hours post dose
Concentration-QTc analysis based on the relationship between plasma concentrations of zelicapavir and ΔΔQTcF after a TD and SD of zelicapavir
Time frame: Up to 96 hours post dose
Cmax of zelicapavir
Time frame: Up to 96 hours post dose
Tmax of zelicapavir
Time frame: Up to 96 hours post dose
t1/2 of zelicapavir
Time frame: Up to 96 hours post dose
Vd/F of zelicapavir
Time frame: Up to 96 hours post dose
CL/F of zelicapavir
Time frame: Up to 96 hours post dose
ΔΔQTcF after moxifloxacin dosing
Time frame: Up to 24 hours post dose
Safety measured by adverse events
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Subjects will receive moxifloxin once per treatment period.
Time frame: Up to Day 33