A Study to Assess the Effect of Olpasiran on QT/QTc Intervals in Healthy Participants
- Registration Number
- NCT06411860
- Lead Sponsor
- Amgen
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
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, Crohn's disease, or irritable bowel syndrome), or a history of gastrointestinal surgery other than uncomplicated appendectomy and hernia repair.
- Inability to swallow oral medication or history of malabsorption syndrome.
- History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
- History of major bleeding disorder (for example: hemophilia, von Willebrand disease, clotting factor deficiencies, etc).
- Participant has received a dose of an investigational drug within the past 90 days or have previously completed or withdrawn from this study or any other study investigating olpasiran or have previously received olpasiran.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment C Olpasiran All participants will be randomized to 1 of 12 treatment sequences and receive a single dose of one of the following treatments, according to the randomization schedule: Treatment A: placebo Treatment B: dose level 1 olpasiran Treatment C: dose level 2 olpasiran Treatment D: moxifloxacin Treatment A Placebo All participants will be randomized to 1 of 12 treatment sequences and receive a single dose of one of the following treatments, according to the randomization schedule: Treatment A: placebo Treatment B: dose level 1 olpasiran Treatment C: dose level 2 olpasiran Treatment D: moxifloxacin Treatment B Olpasiran All participants will be randomized to 1 of 12 treatment sequences and receive a single dose of one of the following treatments, according to the randomization schedule: Treatment A: placebo Treatment B: dose level 1 olpasiran Treatment C: dose level 2 olpasiran Treatment D: moxifloxacin Treatment D Moxifloxacin All participants will be randomized to 1 of 12 treatment sequences and receive a single dose of one of the following treatments, according to the randomization schedule: Treatment A: placebo Treatment B: dose level 1 olpasiran Treatment C: dose level 2 olpasiran Treatment D: moxifloxacin
- Primary Outcome Measures
Name Time Method Placebo-corrected Change From Baseline in QT Corrected for Heart Rate (HR) Interval Based on the Fridericia Correction (QTcF) (ΔΔQTcF) After Olpasiran Dosing Day 3 of Treatment Period 4 (up to approximately 9.5 weeks)
- Secondary Outcome Measures
Name Time Method Change From Baseline in HR Up to 10 weeks Half-life of Olpasiran (t1/2) Up to 10 weeks Area Under the Curve From Time 0 to the Last Quantifiable Concentration (AUClast) Up to 10 weeks Change From Baseline in QTcF Up to 10 weeks Placebo-corrected Change From Baseline in PR Interval Up to 10 weeks Area Under the Curve From Time 0 to Infinity (AUCinf) Up to 10 weeks ΔΔQTcF After Moxifloxacin Dosing Up to 10 weeks Number of Participants With Treatment-emergent Serious Adverse Events Up to 10 weeks Time to Cmax (tmax) of Olpasiran Up to 10 weeks Change From Baseline in PR Interval Up to 10 weeks Maximum Observed Concentration (Cmax) of Olpasiran Up to 10 weeks Placebo-corrected Change From Baseline in QRS Interval Up to 10 weeks Number of Participants with Categorical Outliers Related to the Following ECG parameter: QTcF, HR, PR, and QRS Up to 10 weeks Frequency of Treatment-emergent Changes in Electrocardiogram (ECG) Morphology Up to 10 weeks Number of Participants With Treatment-emergent Adverse Events Up to 10 weeks Change From Baseline in QRS Interval Up to 10 weeks Placebo-corrected Change From Baseline in HR Up to 10 weeks
Trial Locations
- Locations (1)
Fortrea Clinical Research Unit Limited - Leeds
🇬🇧Leeds, United Kingdom