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 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT06594159
Eligibility Criteria:
Inclusion Criteria:
* Japanese participants who are overtly healthy as determined by medical evaluation including medical history and physical examination
* Have a body mass index within the range 18 to 30 kilogram per square meter (kg/m2)
* Have a body weight of:
* ≥ 40 kilograms (kg) for individuals assigned female at birth
* ≥ 50 kg for individuals assigned male at birth
Exclusion Criteria:
* Have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, or convulsions that, in the judgment of the investigator, indicate a medical problem that would preclude study participation
* Have an abnormality in the 12-lead echocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
* Have a history of clinically significant multiple or severe drug allergies or severe posttreatment hypersensitivity reactions, which in the opinion of the investigator may hamper participation in the study
* Show evidence of hepatitis C and/or have a positive hepatitis C virus antibody test
* Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antigen and/or antibodies.
* Show evidence of hepatitis B and/or positive hepatitis B surface antigen
* Show evidence of syphilis or have a positive syphilis test.
* Have an abnormal blood pressure (supine) as determined by the investigator
* Are pregnant or intend to become pregnant or to breastfeed during the study.
* Participants with a history of drug abuse which, in the opinion of the investigator, is clinically significant or who test positive for drugs of abuse at screening or admission
* Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation, or an amount deemed significant by the investigator
* Smoke more than 10 cigarettes per day or the equivalent including electronic cigarettes
* Are unwilling to comply with the dietary restrictions required for this study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06594159
Study Brief:
Protocol Section:
NCT06594159