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 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT05719805
Eligibility Criteria:
Inclusion Criteria:
* Body mass index between 18 and 32 kg/m\^2, inclusive, at the screening visit.
* Healthy, as determined by physical examination, vital signs, 12-lead ECGs, and clinical laboratory assessments (including hematology, chemistry, and urinalysis) within the normal range at the screening visit and/or on Day -1. Participants with values outside of the normal range may be included if the values are not considered, by the investigator, to be clinically significant unless such values are explicitly excluded.
* Cytochrome P450 (CYP2C19) normal (\*1/\*1), rapid (\*1/\*17), or ultra-rapid (\*17/\*17) metabolizer, as determined by genotyping during screening.
Exclusion Criteria:
* Current or history of clinically significant cardiac condition, including but not limited to arrhythmia, LV systolic dysfunction, coronary heart disease; current, history, or family history of HCM; or evidence of prior myocardial infarction based on ECGs.
* Current or recent (within 3 months of study intervention administration) gastrointestinal disease including, but not limited to, bowel obstruction or perforation, gastrointestinal ulcers, esophageal varices, Crohn's disease, diverticulitis, irritable bowel syndrome, ileus, a gastrointestinal tract that is not anatomically intact, dyspepsia, constipation, diarrhea, or vomiting.
* Any gastrointestinal surgery (other than appendectomy) that, in the opinion of the investigator, could impact the absorption of study intervention.
Note: Other protocol-defined inclusion/exclusion criteria apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05719805
Study Brief:
Protocol Section:
NCT05719805