The primary objective of the study is: • To assess the effects of a single therapeutic and supratherapeutic dose of olpasiran on the placebo-corrected change from baseline in QT corrected for heart rate (ΔΔQT)/QTc interval in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
32
Participants will receive a subcutaneous (SC) injection of placebo.
Participants will receive a SC injection of olpasiran at dose level 1 or 2.
Participants will receive a single dose of moxifloxacin as an oral tablet by mouth.
Fortrea Clinical Research Unit Limited - Leeds
Leeds, United Kingdom
Placebo-corrected Change From Baseline in QT Corrected for Heart Rate (HR) Interval Based on the Fridericia Correction (QTcF) (ΔΔQTcF) After Olpasiran Dosing
Time frame: Day 3 of Treatment Period 4 (up to approximately 9.5 weeks)
Maximum Observed Concentration (Cmax) of Olpasiran
Time frame: Up to 10 weeks
Time to Cmax (tmax) of Olpasiran
Time frame: Up to 10 weeks
Half-life of Olpasiran (t1/2)
Time frame: Up to 10 weeks
Area Under the Curve From Time 0 to the Last Quantifiable Concentration (AUClast)
Time frame: Up to 10 weeks
Area Under the Curve From Time 0 to Infinity (AUCinf)
Time frame: Up to 10 weeks
Change From Baseline in HR
Time frame: Up to 10 weeks
Change From Baseline in QTcF
Time frame: Up to 10 weeks
Change From Baseline in PR Interval
Time frame: Up to 10 weeks
Change From Baseline in QRS Interval
Time frame: Up to 10 weeks
Placebo-corrected Change From Baseline in HR
Time frame: Up to 10 weeks
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Placebo-corrected Change From Baseline in PR Interval
Time frame: Up to 10 weeks
Placebo-corrected Change From Baseline in QRS Interval
Time frame: Up to 10 weeks
Number of Participants with Categorical Outliers Related to the Following ECG parameter: QTcF, HR, PR, and QRS
Time frame: Up to 10 weeks
Frequency of Treatment-emergent Changes in Electrocardiogram (ECG) Morphology
Time frame: Up to 10 weeks
ΔΔQTcF After Moxifloxacin Dosing
Time frame: Up to 10 weeks
Number of Participants With Treatment-emergent Adverse Events
Time frame: Up to 10 weeks
Number of Participants With Treatment-emergent Serious Adverse Events
Time frame: Up to 10 weeks