The primary objective of this study was to investigate whether there is a clinically meaningful effect on QTc change from baseline relative to placebo after administration of 10 mg at steady state in patients with stable CAD (coronary artery disease).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
74
A : 2.5 mg vericiguat A\*: 2.5 mg vericiguat B : 5 mg vericiguat C : 10 mg vericiguat C\*: 10 mg vericiguat
D: 400 mg moxifloxacin
A : vericiguat placebo 10 mg A\*: vericiguat placebo 10 mg + moxifloxacin placebo B : vericiguat placebo 10 mg C : vericiguat placebo 2.5 mg C\*: vericiguat placebo 2.5 mg + moxifloxacin placebo D : vericiguat placebo 2.5 mg + vericiguat placebo 10 mg
Universitätsherzzentrum Freiburg - Bad Krozingen
Bad Krozingen, Baden-Wurttemberg, Germany
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Medizinische Einrichtungen der Universität Bonn
Bonn, North Rhine-Westphalia, Germany
SocraTec R&D Clinical Ward
Erfurt, Thuringia, Germany
Time-matched placebo-corrected change from baseline of the QT interval corrected according to Fridericia (QTcF) after 10 mg vericiguat at steady state.
Time frame: Baseline, day 56 (steady state 10 mg) of vericiguat treatment
Time-matched placebo-corrected change from baseline of QTcF after 1st dose of 2.5 mg vericiguat
Time frame: Baseline and day 1 of vericiguat treatment
Time-matched placebo-corrected change from baseline of QTcF after 1st dose of 5 mg vericiguat
Time frame: Baseline and day 15 (+/- 3 days) of vericiguat treatment
Time-matched placebo-corrected change from baseline of QTcF after 1st dose of 10 mg vericiguat
Time frame: Baseline and day 29 (+/- 3 days) of vericiguat treatment
Time-matched placebo-corrected change from baseline of QTcF after 2.5 mg vericiguat at steady state
Time frame: Baseline and day 14 (+/- 3 days) of vericiguat treatment (steady state 2.5 mg)
Time-matched placebo-corrected change from baseline of QTcF after 5 mg vericiguat at steady state
Time frame: Baseline and day 28 (+/- 3 days) of vericiguat treatment (steady state 5 mg)
Time-matched placebo-corrected change from baseline of QTcF after single dose of moxifloxacin
Time frame: Baseline and day 8 of the moxifloxacin treatment period
Maximum concentration of vericiguat in plasma after first dose (Cmax)
Time frame: On profile day 1; Timeframe: 0 - 5 hours after dosing
Time to maximum concentration of vericiguat in plasma after first dose (tmax)
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Charité Campus Virchow-Klinikum (CVK)
Berlin, Germany
PAREXEL GmbH
Berlin, Germany
IMSP Republican Clinical Hospital
Chisinau, Moldova
Center for Human Drug Research
Leiden, Netherlands
Time frame: On profile day 1; Timeframe: 0 - 5 hours after dosing
Maximum concentration of vericiguat in plasma after multiple doses (Cmax, md)
Time frame: On profile days: 8, 14, 15, 28, 29, 42, 43, 50 and 56; Timeframe: 0 - 5 hours after dosing
Time to maximum concentration of vericiguat in plasma after multiple doses (tmax, md)
Time frame: On profile days: 1, 8, 14, 15, 28, 29, 42, 43, 50 and 56; Timeframe: 0 - 5 hours after dosing
Maximum concentration of moxifloxacin in plasma after single dose (Cmax)
Time frame: On moxifloxacin profile days (day 8 and 50); Timeframe: 0 - 5 hours after dosing
Time to maximum concentration of moxifloxacin in plasma after single dose (tmax)
Time frame: On moxifloxacin profile days (day 8 and 50); Timeframe: 0 - 5 hours after dosing
Number of subjects with treatment-emergent adverse events (TEAEs)
Time frame: 12 months