Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT06411860
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06411860
Study Brief:
Protocol Section:
NCT06411860