Study Complete
Sponsor ID
20220016
A Study to Assess the Effect of Olpasiran on QT/QTc Intervals in Healthy Participants
Study Details
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.
Protocol Summary
Primary Outcome Measures
Placebo-corrected Change From Baseline in QT Corrected for Heart Rate (HR) Interval Based on the Fridericia Correction (QTcF) (ΔΔQTcF) After Olpasiran Dosing
Timeframe: Day 3 of Treatment Period 4 (up to approximately 9.5 weeks)
Secondary Outcome Measures
Maximum Observed Concentration (Cmax) of Olpasiran
Timeframe: Up to 10 weeks
Time to Cmax (tmax) of Olpasiran
Timeframe: Up to 10 weeks
Half-life of Olpasiran (t1/2)
Timeframe: Up to 10 weeks
Area Under the Curve From Time 0 to the Last Quantifiable Concentration (AUClast)
Timeframe: Up to 10 weeks
Area Under the Curve From Time 0 to Infinity (AUCinf)
Timeframe: Up to 10 weeks
Change From Baseline in HR
Timeframe: Up to 10 weeks
Change From Baseline in QTcF
Timeframe: Up to 10 weeks
Change From Baseline in PR Interval
Timeframe: Up to 10 weeks
Change From Baseline in QRS Interval
Timeframe: Up to 10 weeks
Placebo-corrected Change From Baseline in HR
Timeframe: Up to 10 weeks
Placebo-corrected Change From Baseline in PR Interval
Timeframe: Up to 10 weeks
Placebo-corrected Change From Baseline in QRS Interval
Timeframe: Up to 10 weeks
Number of Participants with Categorical Outliers Related to the Following ECG parameter: QTcF, HR, PR, and QRS
Timeframe: Up to 10 weeks
Frequency of Treatment-emergent Changes in Electrocardiogram (ECG) Morphology
Timeframe: Up to 10 weeks
ΔΔQTcF After Moxifloxacin Dosing
Timeframe: Up to 10 weeks
Number of Participants With Treatment-emergent Adverse Events
Timeframe: Up to 10 weeks
Number of Participants With Treatment-emergent Serious Adverse Events
Timeframe: Up to 10 weeks
Locations
Location
Fortrea Clinical Research Unit Limited - Leeds
Leeds, United Kingdom, LS11 9EH
Status
Recruiting