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:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT06194032
Eligibility Criteria:
Inclusion Criteria:
* Females must have a negative pregnancy test.
* Have a Basal Metabolic index (BMI) between 19 and 30 kg/m2 inclusive and weigh at least 50 kg.
Exclusion Criteria:
* History of any clinically significant disease or disorder.
* History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* History of additional risk factors for Torsade de Pointes.
* History of neoplastic disease.
* Family history of sudden cardiac death.
* Any skin condition likely to interfere with ECG electrode placement or adhesion.
* Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of drug.
* Any clinically significant abnormalities at screening and first admission in rhythm, conduction, or morphology of the 12-lead resting ECG and any clinically important abnormalities in the 12-lead ECG as considered by the investigator.
* Participant has clinical signs and symptoms consistent with COVID-19.
* Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to screening.
* Positive screen for drugs of abuse, alcohol or cotinine at screening or on each admission to the Clinical Unit.
* Participants who have previously received Baxdrostat.
* Participants with any special dietary restrictions such as participants who are lactose intolerant or are vegetarians/vegans.
* Participants who cannot communicate reliably with the investigator and/or are not able to read, speak, and understand the local language.
* Vulnerable participants, eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06194032
Study Brief:
Protocol Section:
NCT06194032