[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07660731":3,"trial-entities:NCT07660731":182,"trial-summary:NCT07660731":186},{"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":23,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":57,"secondary_outcomes":87,"sex":147,"minimum_age":148,"maximum_age":149,"healthy_volunteers":150,"eligibility_criteria":151,"std_ages":155,"locations":158,"central_contacts":168,"overall_officials":174,"references":177,"see_also_links":178},"NCT07660731","C6611001","A Study to Learn How Different Amounts of the Study Medicine Called PF-08103402 Are Tolerated and Act in the Body in Healthy Adults or Adults With Mild To-moderate Asthma","A PHASE 1 STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, RELATIVE BIOAVAILABILITY, FOOD EFFECT, METABOLISM & EXCRETION, AND DRUG-DRUG INTERACTION POTENTIAL OF PF-08103402 IN HEALTHY ADULTS AND\u002FOR ADULTS WITH MILD TO MODERATE ASTHMA","RECRUITING","2027-06-18","2026-06","2026-06-29","2026-06-17","Pfizer","INDUSTRY",false,"The purpose of this study is to learn about the safety of a new study medicine called PF-08103402 in healthy adults (do not have disease) and or in adults with mild-to-moderate asthma. This is the first time the study medicine is being given to people.\n\nFor Parts A, B, C, D and F, the study is seeking participants who:\n\n* Are healthy (do not have disease) males or females who can no longer have children,\n* Are 18 to 65 years old,\n* Have a body mass index (BMI) of 16 to 32 kilograms per meter squared and a body weight of more than 50 kilograms (110 pounds). Body mass index is a way to measure body fat by using a person's height and weight\n\nFor Part A (optional group or cohort 3: Japanese participants only):\n\n* A body weight of more than 45 kilograms (100 pounds).\n* Have 4 biological Japanese grandparents who were born in Japan.\n\nFor Part E only:\n\n* Adults with a documented history of asthma (confirmed by a doctor) for at least 12 months before entering the study.\n* Have a body mass index (BMI) of 16 to 35 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds).\n\nThe study has six parts: Part A, Part B, Part C, Part D, Part E and Part F. The study medicine will be taken as a suspension or tablet by mouth 1 time a day (except in Parts B and E where it will be taken 1 time a day for 14 days) at the study clinic. The study will help understand:\n\n* how the body processes the study medicine in healthy participants (Parts A and B),\n* how much of the study medicine gets into the bloodstream and if food affects the amount of study medicine in the blood in healthy participants (Part C),\n* how the study medicine is broken down and leaves the body in healthy participants (Optional Part D),\n* how the study medicine is processed in adults with mild-to-moderate asthma (Optional Part E),\n* if taking the study medicine together with another medicine affects how each medicine is processed by the body in healthy participants (Optional Part F).\n\nParticipants will take part in the study for about 10 weeks (Parts A and F), 12 weeks (Part B), 9 weeks (Parts C and D), and 16 weeks (Part E).\n\nDuring this time, they will have 2 study visits at the study clinic and up to 28 overnight stays (Part A), 18 overnight stays (Parts B and E), 10 overnight stays (Part C), 11 overnight stays (Part D), and 16 overnight stays (Part F). The study team will also call participants 1 time over the phone at the end of the study to assess how they are doing.\n\nStudy measurements will be taken by body examination, monitoring side effects, blood and urine tests, heart tests (ECG), vital signs (blood pressure and pulse), questionnaires (Parts C and E), stool samples (Part D only), and breathing tests (Part E only).",null,[19,20,21,22],"Healthy Volunteer Study","Healthy Adults","Healthy Participants","Asthma",[24,25,26,27,28,29],"Human","Randomized","Metabolism","Excretion","Drug-Drug Interaction","Food effect","INTERVENTIONAL","BASIC_SCIENCE",[33],"PHASE1",{"count":35,"type":36},139,"ESTIMATED",[38,49,53],{"type":39,"name":40,"description":41,"armGroupLabels":42},"DRUG","PF-08103402","Oral suspension (Parts A to F); Tablets (Parts C and F only)",[43,44,45,46,47,48],"Part A: Cohorts 1, 2 and Optional Cohort 3","Part B: Cohorts 4, 5, 6, 7, and Optional Cohort 8","Part C: Cohort 9","Part D: Cohort 10 (Optional)","Part E: Cohorts 11 (Optional) and 12 (Optional)","Part F: Cohort 13 (Optional)",{"type":39,"name":50,"description":51,"armGroupLabels":52},"Placebo","Oral suspension (Parts A, B and E).",[43,44,47],{"type":39,"name":54,"description":55,"armGroupLabels":56},"Midazolam","Oral syrup",[48],[58,62,64,67,70,72,75,77,81,85],{"measure":59,"description":60,"timeFrame":61},"Number of Participants with Treatment Emergent Adverse Events (TEAEs)","Part A: Cohorts 1, 2 and Cohort 3 (optional). Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional). Part E: Cohorts 11 (optional) and 12 (optional)","Parts A: Up to Day 36; Part B and E: Up to Day 50",{"measure":63,"description":60,"timeFrame":61},"Number of Participants with Serious Adverse Events (SAEs)",{"measure":65,"description":60,"timeFrame":66},"Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities","Parts A: Change From Baseline to Day 7; Part B and E: Change From Baseline to Day 17",{"measure":68,"description":69,"timeFrame":66},"Number of Participants With Clinically Significant Change From Baseline in Vital Signs","Part A: Cohorts 1, 2 and Cohort 3 (optional). Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional). Part E: Cohorts 11 (optional) and 12 (optional).",{"measure":71,"description":69,"timeFrame":66},"Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings",{"measure":73,"description":45,"timeFrame":74},"Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit, otherwise (AUClast) in the fasted state","Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1",{"measure":76,"description":45,"timeFrame":74},"Maximum observed plasma concentration (Cmax) in the fasted state",{"measure":78,"description":79,"timeFrame":80},"Total recovery of drug-related material in urine and feces separately, and both routes combined, expressed as a percent of total dose administered","Part D: Cohort 10 (optional)","Pre-dose (Hour 0) and at 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 hours post-dose (Day 2)",{"measure":82,"description":83,"timeFrame":84},"Maximum observed plasma concentration (Cmax)","Part F: Cohort 13 (optional)","Pre-dose (Hour 0) and at 0.5, 1, 2, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 hours post-dose (Day 2)",{"measure":86,"description":83,"timeFrame":84},"Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit, otherwise AUClast",[88,92,93,95,97,100,104,105,106,107,109,111,113,114,115,116,117,119,120,121,123,125,129,131,132,133,134,137,138,140,141,143,145,146],{"measure":89,"description":90,"timeFrame":91},"Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)","Part A: Cohorts 1, 2 and Cohort 3 (optional).","Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 and 36 hours post-dose (Day 2)",{"measure":82,"description":90,"timeFrame":91},{"measure":94,"description":90,"timeFrame":91},"Time of Maximum observed plasma concentration (Tmax)",{"measure":96,"description":90,"timeFrame":91},"Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit",{"measure":98,"description":99,"timeFrame":91},"Half-life (t½) if data permit","Part A: Cohorts 1, 2 and Cohort 3 (optional)",{"measure":101,"description":102,"timeFrame":103},"Area under the curve over 1 dosing interval (AUCtau)","Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional).","Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1, Day 7 and Day 14",{"measure":82,"description":102,"timeFrame":103},{"measure":94,"description":102,"timeFrame":103},{"measure":98,"description":102,"timeFrame":103},{"measure":59,"description":45,"timeFrame":108},"Up to Day 36",{"measure":110,"description":45,"timeFrame":108},"Number of Participants With Serious Adverse Events (SAEs)",{"measure":65,"description":45,"timeFrame":112},"Change From Baseline to Day 4",{"measure":68,"description":45,"timeFrame":112},{"measure":71,"description":45,"timeFrame":112},{"measure":59,"description":79,"timeFrame":108},{"measure":110,"description":79,"timeFrame":108},{"measure":65,"description":79,"timeFrame":118},"Change From Baseline to Day 11",{"measure":68,"description":79,"timeFrame":118},{"measure":71,"description":79,"timeFrame":118},{"measure":86,"description":79,"timeFrame":122},"Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1, 24 hours post-dose (Day 2), 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6), 144 hours post-dose (Day 7)",{"measure":82,"description":79,"timeFrame":124},"Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1, 24 hours post-dose (Day 2), 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6), 144 hours post-dose (Day 7).",{"measure":126,"description":127,"timeFrame":128},"Change From Baseline (CFB) in Fractional concentration of exhaled Nitric Oxide (FeNO) at Day 14","Part E: Cohorts 11 (optional) and 12 (optional)","Pre-dose (Hour 0) and at 72 hours post-dose (Day 4), 144 hours post-dose (Day 7), 264 hours post-dose (Day 12), 312 hours post-dose (Day 14) and 384 hours post-dose (Day 17)",{"measure":101,"description":127,"timeFrame":130},"Pre-dose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose (Day 1); 24 hours post-dose (Day 2); 144 hours post-dose (Day 7); 312 hours post-dose (Day 14); 336 hours post-dose (Day 15); 360 hours post-dose (Day 16); 384 hours post-dose (Day 17)",{"measure":82,"description":127,"timeFrame":130},{"measure":94,"description":127,"timeFrame":130},{"measure":98,"description":127,"timeFrame":130},{"measure":135,"description":83,"timeFrame":136},"Number of Participants With Treatment Emergent Adverse Events (TEAEs)","Up to Day 51",{"measure":110,"description":83,"timeFrame":136},{"measure":68,"description":83,"timeFrame":139},"Change From Baseline to Day 16",{"measure":71,"description":83,"timeFrame":139},{"measure":101,"description":83,"timeFrame":142},"Pre-dose (Hour 0) and at 0.5, 1, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 hours post-dose (Day 2)",{"measure":82,"description":83,"timeFrame":144},"Pre-dose (Hour 0) and at 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1 (Period 1 ) and on Day 1 and Day 14 (Period 2)",{"measure":94,"description":83,"timeFrame":144},{"measure":98,"description":83,"timeFrame":144},"ALL","18 Years","65 Years",true,{"inclusion":152,"exclusion":153,"raw_text":154},[],[],"Key Inclusion criteria (Parts A, B, C, D and F):\n\n1. Are males or females who can no longer have children,\n2. Are 18 to 65 years old,\n3. Have a body mass index (BMI) of 16 to 32 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds).\n\nFor Part A (Optional group or cohort 3: Japanese participants only):\n\n1. A total body weight of more than 45 kg (100 pounds).\n2. Have 4 biological Japanese grandparents who were born in Japan.\n\nFor Part E only:\n\nAdults with a documented doctor's-diagnosis history of asthma for at least 12 months before entering the study.\n\n1\\. Have a body mass index (BMI) of 16 to 35 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds).\n\nKey Exclusion criteria\n\n1. Evidence or history of clinically significant medical conditions.\n2. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb).\n3. History of alcohol abuse or binge drinking and\u002For any other illicit drug use or dependence within 6 months of Screening.\n4. Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.\n5. Any history of parasitic infection requiring treatment within 28 days prior to screening.\n6. Positive tuberculosis infection test result.\n7. Part C only: Evidence or history of conditions interfering with the ability to taste.\n8. Part D only: History of irregular bowel movements.\n9. Part E only: Evidence of lung disease(s) other than asthma.\n10. Part E only: Asthma exacerbation within 3 months prior to screening.\n11. Part F only: History of acute narrow-angle glaucoma, untreated open-angle glaucoma, sleep apnea, respiratory insufficiency, myasthenia gravis or adverse reaction to midazolam or other benzodiazepines.",[156,157],"ADULT","OLDER_ADULT",[159],{"facility":160,"status":8,"city":161,"state":162,"zip":163,"country":164,"geoPoint":165},"Pfizer Clinical Research Unit - New Haven","New Haven","Connecticut","06511","United States",{"lat":166,"lon":167},41.30815,-72.92816,[169],{"name":170,"role":171,"phone":172,"email":173},"Pfizer CT.gov Call Center","CONTACT","1-800-718-1021","ClinicalTrials.gov_Inquiries@pfizer.com",[175],{"name":170,"affiliation":13,"role":176},"STUDY_DIRECTOR",[],[179],{"label":180,"url":181},"To obtain contact information for a study center near you, click here.","https:\u002F\u002Fpmiform.com\u002Fclinical-trial-info-request?StudyID=C6611001",{"nct_id":4,"conditions":183,"biomarkers":185},[22,184],"Healthy Volunteers",[],{"nct_id":4,"found":150,"summary":187,"prompt_version":197},{"design":188,"status":189,"heading":190,"summary":191,"follow_up":192,"word_count":193,"commitments":194,"compensation":195,"drugs_mentioned":196},"This is an interventional study, meaning participants will receive a specific treatment. The study is testing different amounts of PF-08103402 or a placebo.","completed","PF-08103402 Study for Healthy Adults and Adults with Asthma","This study is looking at a new medicine called PF-08103402, given as an oral suspension or tablets, to see how safe it is and how it acts in the body. This is the first time PF-08103402 is being given to people. We are looking for healthy adults or adults with mild-to-moderate asthma, aged 18 to 65, who can no longer have children. The study will also use a placebo (an inactive substance) and Midazolam (an oral syrup). We will measure how many participants experience side effects or serious adverse events, and any significant changes in lab test results. The study aims to enroll 139 participants.","Participants will be followed for side effects and serious adverse events for up to 36 or 50 days, depending on the study part. Lab changes will be monitored for up to 7 or 17 days.",105,"Not specified in the trial record.","Not stated in the trial record.",[40,50,54],"v2"]