A Study to Assess the Effect of Olpasiran on QT/QTc Intervals in Healthy Participants (NCT06411860) | Clinical Trial Compass
CompletedPhase 1
A Study to Assess the Effect of Olpasiran on QT/QTc Intervals in Healthy Participants
United Kingdom32 participantsStarted 2024-09-12
Plain-language summary
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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion Criteria:
* Provide informed consent prior to starting study activities.
* Healthy male or female participants, between 18 and 60 years of age (inclusive) at the time of Screening. Females must be of nonchildbearing potential.
* Body mass index between 18 and 30 kg/m\^2 (inclusive) at the time of Screening. Participants must have a body mass ≥ 50kg.
Exclusion Criteria:
* History or evidence, at Screening or Check-in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
* History or current signs or symptoms of cardiovascular disease, including but not limited to myocardial infarction, congenital heart disease, valvular heart disease coronary revascularization, or angina.
* History or evidence of clinically significant arrhythmia at screening, including any clinically significant findings on the ECG taken at Check-in.
* Systolic blood pressure \> 150 mmHg or \< 90 mmHg, or diastolic blood pressure \> 90 mmHg or \< 50 mmHg, or HR ≤ 40 and \> 100 bpm, at Screening or Check-in; one repeat blood pressure measurement will be allowed at Screening and Check-in.
* History suggestive of esophageal (including esophageal spasm, esophagitis), gastric, or duodenal ulceration or bowel disease (including but not limited to peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Cro…
What they're measuring
1
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)