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 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT07051993
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) within the range of 18 to 32 kg/m\^2, inclusive
* Negative hepatitis panel and negative HIV antibody screens
* Negative screening test for latent Mycobacterium tuberculosis infection
* Able to consume the high-fat meal within the protocol-specified time period and willing to consume 100% of the high-fat meal
* Able to fast for 8 hours prior to dosing
Exclusion Criteria:
* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, or psychiatric disorder
* Personal or family history of congenital long QT syndrome
* History of significant hypersensitivity, intolerance, or allergy to any drug
* History of acute GI symptoms
* History of ophthalmological disease or clinically significant abnormality in the ophthalmic examination
* Have significantly impaired hepatic function
* Female who is pregnant or breastfeeding or intending to become pregnant during the study or within 90 days following the final ZN-A-1041 administration
* Have a QTc interval corrected through use of Fredericia's formula \>450 millisecond (msec), PR interval \>210 msec, QRS complex \>120 msec, or heart rate \<50 beats per minute (bpm)
* Use of any drugs known to be moderate or strong inhibitors or inducers of CYP3A or CYP2C8
* Poor peripheral venous access
* History of malignancy within 5 years prior to enrollment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07051993
Study Brief:
Protocol Section:
NCT07051993