[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07610005":3,"trial-entities:NCT07610005":104,"trial-summary:NCT07610005":107},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":38,"secondary_outcomes":46,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":59,"eligibility_criteria":60,"std_ages":83,"locations":85,"central_contacts":95,"overall_officials":101,"references":102,"see_also_links":103},"NCT07610005","VAR-505","A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants","A Phase 1, Open-Label, Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Varegacestat Administered in Different Dose Forms in Healthy Participants","RECRUITING","2026-06","2026-06-08","2026-05-21","Immunome, Inc.","INDUSTRY",false,"This is an open-label, randomized, crossover study to evaluate the relative bioavailability (rBA) and bioequivalence (BE) of a test capsule formulation of varegacestat compared to reference capsules formulation under fasting conditions.",null,[18],"Healthy",[],"INTERVENTIONAL","OTHER",[23],"PHASE1",{"count":25,"type":26},20,"ESTIMATED",[28,35],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DRUG","Varegacestat Reference Formulation","Oral administration",[33,34],"Reference Formulation, then Test Formulation","Test Formulation, then Reference Formulation",{"type":29,"name":36,"description":31,"armGroupLabels":37},"Varegacestat Test Formulation",[33,34],[39,42,44],{"measure":40,"timeFrame":41},"Evaluate the rBA of varegacestat by AUC0-t","Approximately 3 weeks",{"measure":43,"timeFrame":41},"Evaluate the rBA of varegacestat by AUC0-inf",{"measure":45,"timeFrame":41},"Evaluate the rBA of varegacestat by Cmax",[47,50,52,54],{"measure":48,"timeFrame":49},"Assess the safety and tolerability of varegacestat by incidence of treatment emergent adverse events","Approximately 4 weeks",{"measure":51,"timeFrame":41},"Assess the safety and tolerability of varegacestat by incidence of laboratory abnormalities",{"measure":53,"timeFrame":41},"Assess the safety and tolerability of varegacestat by incidence of changes in vital signs from baseline",{"measure":55,"timeFrame":41},"Assess the safety and tolerability of varegacestat by incidence of changes from baseline of 12-lead ECG assessments","ALL","18 Years","55 Years",true,{"inclusion":61,"exclusion":68,"raw_text":82},[62,63,64,65,66,67],"Healthy, adult, female of non childbearing potential or male, 18 to 55 years of age, inclusive, at the screening visit","Male participants must follow protocol-specified contraception guidance","Continuous non-smoker who has not used nicotine and tobacco containing products for at least 3 months prior to the first dosing","BMI ≥ 18.0 and ≤ 32.0 kg\u002Fm2 and with a body weight \\> 50 kg at the screening visit","Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and ECGs, as deemed by the PI or designee","Able to swallow multiple capsules",[69,70,71,72,73,74,75,76,77,78,79,80,81],"Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study","History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee","History of any illness that, in the opinion of the PI or designee might confound the results of the study or poses an additional risk to the participant by their participation in the study","History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing","History or presence of hypersensitivity or idiosyncratic reaction to varegacestat or related compounds","History or presence of:","Autoimmune disease such as rheumatoid arthritis or systemic lupus erythematosus","Thrombophlebitis or deep vein thrombosis","Hematologic or coagulation disorders","Liver disease or dysfunction; Gilbert's syndrome","Renal dysfunction or glomerulonephritis","Cancer (except treated basal cell carcinoma of the skin and cancer-free for 5 years, non metastatic basal or squamous cell carcinoma of the skin, and cervical carcinoma in situ)","Clinically significant cardiovascular, gastrointestinal, pulmonary, endocrine, central nervous system disorders, or other major active and uncontrolled disease in the opinion of the PI or designee.","Inclusion Criteria:\n\n* Healthy, adult, female of non childbearing potential or male, 18 to 55 years of age, inclusive, at the screening visit\n* Male participants must follow protocol-specified contraception guidance\n* Continuous non-smoker who has not used nicotine and tobacco containing products for at least 3 months prior to the first dosing\n* BMI ≥ 18.0 and ≤ 32.0 kg\u002Fm2 and with a body weight \\> 50 kg at the screening visit\n* Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and ECGs, as deemed by the PI or designee\n* Able to swallow multiple capsules\n\nExclusion Criteria:\n\n* Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study\n* History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee\n* History of any illness that, in the opinion of the PI or designee might confound the results of the study or poses an additional risk to the participant by their participation in the study\n* History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing\n* History or presence of hypersensitivity or idiosyncratic reaction to varegacestat or related compounds\n* History or presence of:\n\n  * Autoimmune disease such as rheumatoid arthritis or systemic lupus erythematosus\n  * Thrombophlebitis or deep vein thrombosis\n  * Hematologic or coagulation disorders\n  * Liver disease or dysfunction; Gilbert's syndrome\n  * Renal dysfunction or glomerulonephritis\n  * Cancer (except treated basal cell carcinoma of the skin and cancer-free for 5 years, non metastatic basal or squamous cell carcinoma of the skin, and cervical carcinoma in situ)\n  * Clinically significant cardiovascular, gastrointestinal, pulmonary, endocrine, central nervous system disorders, or other major active and uncontrolled disease in the opinion of the PI or designee.",[84],"ADULT",[86],{"facility":87,"status":8,"city":88,"state":89,"zip":90,"country":91,"geoPoint":92},"Celerion, Inc.","Tempe","Arizona","85283","United States",{"lat":93,"lon":94},33.41477,-111.90931,[96],{"name":97,"role":98,"phone":99,"email":100},"Immunome Medical Monitor","CONTACT","425.939.7410","info@immunome.com",[],[],[],{"nct_id":4,"conditions":105,"biomarkers":106},[18],[],{"nct_id":4,"found":59,"summary":108,"prompt_version":118},{"design":109,"status":110,"heading":111,"summary":112,"follow_up":113,"word_count":114,"commitments":115,"compensation":116,"drugs_mentioned":117},"This is an open-label, randomized, crossover study, meaning you and the researchers will know which form of varegacestat you are taking, and you will receive both forms at different times. Approximately 20 healthy participants will be enrolled.","completed","Varegacestat Bioavailability Study in Healthy Participants","This study is looking for healthy adults aged 18 to 55 to compare two different capsule forms of varegacestat. Researchers want to see how well the body absorbs and uses a \"test\" capsule of varegacestat compared to a \"reference\" capsule. This is important for understanding if the different forms deliver the drug similarly. The study will measure the amount of varegacestat in your body over approximately three weeks. We are looking to enroll about 20 participants for this study. The current recruitment status is unclear.","The study will evaluate the drug levels over approximately 3 weeks.",85,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]