Study Complete
Sponsor ID
20220016

A Study to Assess the Effect of Olpasiran on QT/QTc Intervals in Healthy Participants

Sponsor ID
20220016
Clinicaltrials.gov ID
NCT06411860
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1
Product
Olpasiran
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
32
Additional Study Details

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
Status
Contact Us
Location
Fortrea Clinical Research Unit Limited - Leeds
Leeds, United Kingdom, LS11 9EH
Status
Recruiting