Phase
Condition
N/ATreatment
Vepdegestrant (Reference)
Vepdegestrant (Test)
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Male participants, and/or female participants of non-childbearing potential who arehealthy as determined by medical evaluation including medical history, physicalexamination, laboratory tests, and cardiac monitoring.
Body mass index (BMI) of 16-32 kg/m2; and a total body weight >45 kg (99 lb).
Exclusion
Key Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine,pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, orallergic disease.
Any condition possibly affecting drug absorption (eg, gastrectomy,cholecystectomy)
History of or positive testing for HIV infection, hepatitis B, or hepatitis C.
Any medical or psychiatric condition including recent (within the past year) oractive suicidal ideation/behavior or laboratory abnormality or other conditions thatmay increase the risk of study participation or, in the investigator's judgment,make the participant inappropriate for the study.
Use of prescription or nonprescription drugs and dietary and herbal supplements,grapefruit/grapefruit containing products, and Seville orange/Seville orangecontaining products within 7 days or 5 half lives (whichever is longer) prior to thefirst dose of study intervention.
Previous administration with an investigational product (drug or vaccine) within 30days or 5 half lives preceding the first dose of study intervention used in thisstudy (whichever is longer).
A positive urine drug test
Screening blood pressure ≥140/90 mm Hg for participants <60 years; and ≥150/90 mm Hgfor participants ≥60 years old.
Renal impairment as defined by an eGFR in adults <60 mL/min/1.73 m² based on CKD-EPIequation.
Standard 12 lead electrocardiogram that demonstrates clinically relevantabnormalities that may affect participant safety or interpretation of study results (eg, QTcF >450 ms, complete left bundle branch block, signs of a myocardialinfarction, ST T interval changes suggestive of myocardial ischemia, second or thirddegree AV block, or serious bradyarrhythmias or tachyarrhythmias).
History of alcohol abuse or repeated binge drinking and/or any other illicit druguse or dependence within 6 months of Screening.
6 months prior or current use of tobacco or nicotine-containing products in excessof the equivalent of 5 cigarettes/day or 2 chews of tobacco/day.
History of sensitivity to heparin or heparin-induced thrombocytopenia.
Study Design
Connect with a study center
ICON
Groningen, 9728 NZ
NetherlandsActive - Recruiting
ICON - screening centre
Utrecht, 3584 BL
NetherlandsActive - Recruiting
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