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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07439250
Eligibility Criteria:
Inclusion Criteria:
* Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
* Must have a Body Mass Index (BMI) within the range of 18.0 to 30.0 kilograms per square meter (kg/m2)
* Participants assigned male at birth (AMAB) or participants assigned female at birth (AFAB) who are individuals not of childbearing potential (INOCBP).
Exclusion Criteria:
* History or presence of the following conditions:
* metabolic disease
* biliary disease
* gastrointestinal disease
* hematological disease
* neurological disease
* significant history of hepatic disease
* clinically significant, active cardiovascular disease or history of myocardial infarction within 6 months prior to Day 1
* Abnormal blood pressure or pulse rate
* Have a 12-lead electrocardiogram (ECG) abnormality, in the opinion of the investigator, increases the risks associated with participating in the study, or may confound ECG analysis
* History of malignancy within 5 years prior to screening, except for basal cell or squamous epithelial carcinomas of the skin or in situ carcinoma of the cervix, that have been resected with no evidence of metastatic disease for 3 years.
* Show evidence of Human Immunodeficiency Virus (HIV) infection or positive HIV antibodies
* Have a positive hepatitis C antibody test
* Have evidence of hepatitis B at screening, that is, positive test for hepatitis B surface antigen, Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA), or both.
* Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation
* Use of tobacco, smoking-cessation products, electronic (e)-cigarettes (nicotine and non-nicotine), or nicotine products within 90 days prior to first olomorasib administration and through the end of trial
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT07439250
Study Brief:
Protocol Section:
NCT07439250