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 @ 11:50 AM
Ignite Modification Date:
2025-12-24 @ 11:50 AM
NCT ID:
NCT06347861
Eligibility Criteria:
Inclusion Criteria:
* Male participants and/or female participants of non-childbearing potential aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and standard 12-lead ECGs.
* BMI of 16-32 kg/m2; and a total body weight \>45 kg (99.2 lb).
* Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in the informed consent document (ICD) and in this protocol.
* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Exclusion Criteria:
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Participants with known history of sensitivity to vepdegestrant or any of the formulation components of vepdegestrant.
* Use of prescription or nonprescription drugs, including vitamins, dietary, herbal supplements, grapefruit/grapefruit containing products, and Seville orange/Seville orange containing products within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention. A longer washout is required for those that fall into the categories below:
* Moderate or strong CYP3A inducers which are prohibited within 14 days plus 5 half-lives prior to the first dose of study intervention.
* Moderate or strong CYP3A inhibitors which are prohibited within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention (unless otherwise indicated in the protocol).
* Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
* History of sensitivity to heparin or heparin-induced thrombocytopenia.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06347861
Study Brief:
Protocol Section:
NCT06347861