[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07731100":3,"trial-entities:NCT07731100":99,"trial-summary:NCT07731100":103},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":39,"secondary_outcomes":47,"sex":59,"minimum_age":60,"maximum_age":17,"healthy_volunteers":61,"eligibility_criteria":62,"std_ages":72,"locations":75,"central_contacts":85,"overall_officials":91,"references":94,"see_also_links":95},"NCT07731100","C4551008","A Study to Learn About How Food Affects the Uptake of Study Medicine Prifetrastat Into the Blood in Healthy Adults","A PHASE 1, RANDOMIZED, OPEN-LABEL, 2-PERIOD, 2-SEQUENCE, SINGLE-DOSE, CROSSOVER STUDY IN HEALTHY PARTICIPANTS TO EVALUATE THE EFFECT OF FOOD ON THE RELATIVE BIOAVAILABILITY OF PRIFETRASTAT","NOT_YET_RECRUITING","2026-10-02","2026-07","2026-07-28","2026-07-24","Pfizer","INDUSTRY",false,"The purpose of the study is to assess the effect of food (high-fat, high-calorie meal) on the total and peak drug exposure of the planned to be marketed tablet formulation of prifetrastat.\n\nThis study is seeking participants who are:\n\n\\- Healthy males and females of nonchildbearing potential ≥18 years of age at screening\n\nThe participants will receive study medicine prifetrastat as a single tablet by mouth at study clinic under fed or fasted condition. After at least 14 days, they will receive another single tablet of prifetrastat by mouth under fasted or fed condition. The sequence of conditions (fed or fasted first) will be randomized.\n\nThe results of this study will enable data-driven guidance regarding food intake for participants enrolled in clinical studies of prifetrastat as well as patients receiving prifetrastat post-marketing. Participants will remain in clinic for about 21 days and have one follow up contact.",null,[19],"Healthy Adults",[21,22,23],"Prifetrastat","Food Effect","PF-07248144","INTERVENTIONAL","BASIC_SCIENCE",[27],"PHASE1",{"count":29,"type":30},12,"ESTIMATED",[32],{"type":33,"name":21,"description":34,"armGroupLabels":35,"otherNames":38},"DRUG","Participants will receive Prifetrastat as a single dose, oral tablet on Day 1 of Period 1 and Day 1 of Period 2 with a washout period between two doses",[36,37],"Sequence AB","Sequence BA",[23],[40,43,45],{"measure":41,"timeFrame":42},"Area under the concentration-time curve from time zero to extrapolated infinite time (AUCinf) for Prifetrastat","0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours post-dose",{"measure":44,"timeFrame":42},"Area under the concentration-time curve from time zero to time of last measurable concentration (AUClast) for Prifetrastat",{"measure":46,"timeFrame":42},"Maximum observed plasma concentration (Cmax) for Prifetrastat",[48,51,53,55,57],{"measure":49,"timeFrame":50},"Number of participants with treatment-emergent adverse events","Up to 28 to 35 days post last study intervention dose",{"measure":52,"timeFrame":50},"Number of participants with laboratory test abnormalities",{"measure":54,"timeFrame":50},"Number of participants with vital signs values meeting categorical summarization criteria",{"measure":56,"timeFrame":50},"Number of participants with clinically significant physical examination abnormalities",{"measure":58,"timeFrame":50},"Number of participants with treatment emergent clinically significant abnormal electrocardiogram (ECG) measurements","ALL","18 Years",true,{"inclusion":63,"exclusion":66,"raw_text":71},[64,65],"Females of nonchildbearing potential and males ≥18 years of age at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs.","Body mass Index (BMI) of 18-32 kg\u002Fm2; and a total body weight \\>50 kg (110 lb).",[67,68,69,70],"Use of prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention","Any prior use of epigenetic modifying agents.","Current use or anticipated need for food or drugs that are known moderate or strong inducers or inhibitors of CYP2C9 or CYP3A4, including their administration within 14 days plus 5 half-lives of the inducers or 14 days or 5 half lives (whichever is longer) for the inhibitors of CYP2C9 or CYP3A4, prior to first dose of study intervention, during the treatment period, and within 6 days after the last dose of prifetrastat.","Proton pump inhibitors must be discontinued at least 14 days prior to the first dose of study medication and throughout treatment period.","Inclusion Criteria\n\n* Females of nonchildbearing potential and males ≥18 years of age at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs.\n* Body mass Index (BMI) of 18-32 kg\u002Fm2; and a total body weight \\>50 kg (110 lb).\n\nExclusion Criteria\n\n* Use of prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention\n* Any prior use of epigenetic modifying agents.\n* Current use or anticipated need for food or drugs that are known moderate or strong inducers or inhibitors of CYP2C9 or CYP3A4, including their administration within 14 days plus 5 half-lives of the inducers or 14 days or 5 half lives (whichever is longer) for the inhibitors of CYP2C9 or CYP3A4, prior to first dose of study intervention, during the treatment period, and within 6 days after the last dose of prifetrastat.\n* Proton pump inhibitors must be discontinued at least 14 days prior to the first dose of study medication and throughout treatment period.",[73,74],"ADULT","OLDER_ADULT",[76],{"facility":77,"city":78,"state":79,"zip":80,"country":81,"geoPoint":82},"Pfizer Clinical Research Unit - New Haven","New Haven","Connecticut","06511","United States",{"lat":83,"lon":84},41.30815,-72.92816,[86],{"name":87,"role":88,"phone":89,"email":90},"Pfizer CT.gov Call Center","CONTACT","1-800-718-1021","ClinicalTrials.gov_Inquiries@pfizer.com",[92],{"name":87,"affiliation":13,"role":93},"STUDY_DIRECTOR",[],[96],{"label":97,"url":98},"To obtain contact information for a study center near you, click here.","https:\u002F\u002Fpmiform.com\u002Fclinical-trial-info-request?StudyID=C4551008",{"nct_id":4,"conditions":100,"biomarkers":102},[101],"Healthy Volunteers",[],{"nct_id":4,"found":61,"summary":104,"prompt_version":114},{"design":105,"status":106,"heading":107,"summary":108,"follow_up":109,"word_count":110,"commitments":111,"compensation":112,"drugs_mentioned":113},"This is an interventional study involving 12 healthy adult participants. Participants will receive Prifetrastat twice, once fed and once fasted, with the order randomized.","completed","Study on How Food Affects Prifetrastat Uptake","This study is looking for healthy adults to understand how food affects how much of the medicine Prifetrastat gets into your blood. Researchers want to see if eating a high-fat, high-calorie meal changes how your body absorbs Prifetrastat compared to taking it on an empty stomach. You would receive Prifetrastat as a single tablet on two separate occasions, once after eating and once on an empty stomach, with at least 14 days in between. The order of fed or fasted conditions will be decided randomly. The study aims to measure the total amount and peak level of Prifetrastat in your blood over several days after each dose. This study is currently unclear on its recruitment status and plans to enroll 12 participants.","Your blood levels of Prifetrastat will be measured for up to 144 hours (6 days) after each dose.",122,"You would take a single Prifetrastat tablet on two separate days, at least 14 days apart. Blood samples will be taken frequently over 144 hours (6 days) after each dose.","Not stated in the trial record.",[21],"v2"]