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:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT06846528
Eligibility Criteria:
Inclusion Criteria:
* All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
* Females of non-childbearing potential must be postmenopausal for at least 12 months or have documentation of irreversible surgical sterilization.
* Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
* Have a Body Mass Index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 50 kg.
Exclusion Criteria:
* History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
* Abnormal laboratory values, clinically important abnormalities or abnormal vital signs
* Any positive result on screening for serum Hepatitis B surface antigen/antibody, Hepatitis C, or Human Immunodeficiency Virus.
* Current smokers (within 3 months prior to screening visit) or history of alcohol and drug abuse
* History of severe allergy or hypersensitivity
* Excessive intake of caffeine-containing drinks or food
* Use of drugs with enzyme inducing properties or use of any prescribed or nonprescribed medication including antacids, analgesics
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06846528
Study Brief:
Protocol Section:
NCT06846528