[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07723833":3,"trial-entities:NCT07723833":144,"trial-summary:NCT07723833":147},{"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":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":65,"secondary_outcomes":90,"sex":95,"minimum_age":96,"maximum_age":97,"healthy_volunteers":98,"eligibility_criteria":99,"std_ages":115,"locations":117,"central_contacts":135,"overall_officials":141,"references":142,"see_also_links":143},"NCT07723833","D7260C00023","A Study to Investigate the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants","A Phase I, Randomized, Single-dose, Crossover, 2-Period, Open-Label Study to Assess the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants","RECRUITING","2026-11-18","2026-07","2026-08-03","2026-07-27","AstraZeneca","INDUSTRY",false,"The purpose of this study is to measure the pharmacokinetics (PK-how the body processes the study drug) of elecoglipron in healthy participants when taken by mouth as different formulations.","This is a phase I, open-label, randomized, 2-period crossover study with 4-cohorts. All 4 cohorts are independent and non-sequential parts in this study. Each cohort will evaluate 2 formulations (test formulation and reference formulation) of elecoglipron across 2 study treatment periods. Participants within each cohort will be randomized to one of 2 treatment sequences (Test-Reference or Reference-Test).\n\nIn total 3 formulations will be evaluated at 2 dose levels each:\n\n* Reference formulation\n* Test formulation 1\n* Test formulation 2\n\nThe study will comprise:\n\n* A Screening Period.\n* 2 treatment periods in each cohort - Period 1, and Period 2 during which participants will be admitted to the Clinical Unit and receive a single oral dose of elecoglipron in each period.\n* A final Follow-up Visit.",[19],"Healthy Participants",[21,22,23,24,25,26,27,28],"Glucagon-like peptide receptor agonist (GLP-1RA)","Type 2 Diabetes Mellitus (T2DM)","Glucose Metabolism Disorders","Metabolic Diseases","Obesity management","Pharmacokinetics","Relative bioavailability","Obesity and Related Co-morbidities","INTERVENTIONAL","TREATMENT",[32],"PHASE1",{"count":34,"type":35},152,"ESTIMATED",[37,46,49,56,59,62],{"type":38,"name":39,"description":40,"armGroupLabels":41},"DRUG","Elecoglipron Reference Formulation Dose A","Elecoglipron tablets will be administered orally.",[42,43,44,45],"Cohort 1 - Treatment Sequence B","Cohort 1-Treatment Sequence A","Cohort 3 - Treatment Sequence E","Cohort 3 - Treatment Sequence F",{"type":38,"name":47,"description":40,"armGroupLabels":48},"Elecoglipron Test formulation 1 Dose A",[42,43],{"type":38,"name":50,"description":40,"armGroupLabels":51},"Elecoglipron Reference Formulation Dose B",[52,53,54,55],"Cohort 2 - Treatment Sequence C","Cohort 2 - Treatment Sequence D","Cohort 4 - Treatment Sequence G","Cohort 4 - Treatment Sequence H",{"type":38,"name":57,"description":40,"armGroupLabels":58},"Elecoglipron Test formulation 1 Dose B",[52,53],{"type":38,"name":60,"description":40,"armGroupLabels":61},"Elecoglipron Test formulation 2 Dose A",[44,45],{"type":38,"name":63,"description":40,"armGroupLabels":64},"Elecoglipron Test formulation 2 Dose B",[54,55],[66,70,72,74,76,78,80,82,84,86,88],{"measure":67,"description":68,"timeFrame":69},"Maximum observed drug concentration (Cmax)","To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.","At pre-defined intervals from Day 1 to Day 15",{"measure":71,"description":68,"timeFrame":69},"Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)",{"measure":73,"description":68,"timeFrame":69},"Area under concentration-time curve from time 0 to infinity (AUCinf)",{"measure":75,"description":68,"timeFrame":69},"Time to reach maximum observed concentration (tmax)",{"measure":77,"description":68,"timeFrame":69},"Terminal elimination rate constant (λz)",{"measure":79,"description":68,"timeFrame":69},"Terminal elimination half-life (t1\u002F2λz)",{"measure":81,"description":68,"timeFrame":69},"Apparent total body clearance (CL\u002FF)",{"measure":83,"description":68,"timeFrame":69},"Apparent volume of distribution based on the terminal phase (Vz\u002FF)",{"measure":85,"description":68,"timeFrame":69},"Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUCinf (R AUCinf)",{"measure":87,"description":68,"timeFrame":69},"Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUClast (R AUClast)",{"measure":89,"description":68,"timeFrame":69},"Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on Cmax (R Cmax)",[91],{"measure":92,"description":93,"timeFrame":94},"Number of participants with adverse events (AEs)","To assess the safety and tolerability of different formulations of elecoglipron following single oral administration in healthy participants.","From screening (Day -28) up to follow-up visit (Day 18-Day 22)","ALL","18 Years","55 Years",true,{"inclusion":100,"exclusion":107,"raw_text":114},[101,102,103,104,105,106],"Healthy participants with suitable veins for cannulation or repeated venipuncture.","All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.","Females of childbearing potential must not be lactating and if heterosexually active, must agree to use an approved method of highly effective contraception.","Females of non-childbearing potential must be confirmed at screening visit as postmenopausal or have documentation of irreversible surgical sterilization.","Sexually active fertile male participants with partners of childbearing potential must adhere to the study specific contraception methods.","Have a body mass index between 18.5 and 30 kg\u002Fm2 inclusive and weigh at least 50 kg.",[108,109,110,111,112,113],"History of any clinically important disease or disorder.","History of acute pancreatitis.","History or presence of gastrointestinal (GI) or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.","Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract.","Any clinically important illness, medical\u002Fsurgical procedure, or trauma.","Participants who have previously received elecoglipron within the last 3 months.","Inclusion Criteria:\n\n* Healthy participants with suitable veins for cannulation or repeated venipuncture.\n* All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.\n* Females of childbearing potential must not be lactating and if heterosexually active, must agree to use an approved method of highly effective contraception.\n* Females of non-childbearing potential must be confirmed at screening visit as postmenopausal or have documentation of irreversible surgical sterilization.\n* Sexually active fertile male participants with partners of childbearing potential must adhere to the study specific contraception methods.\n* Have a body mass index between 18.5 and 30 kg\u002Fm2 inclusive and weigh at least 50 kg.\n\nExclusion Criteria:\n\n* History of any clinically important disease or disorder.\n* History of acute pancreatitis.\n* History or presence of gastrointestinal (GI) or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.\n* Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract.\n* Any clinically important illness, medical\u002Fsurgical procedure, or trauma.\n* Participants who have previously received elecoglipron within the last 3 months.",[116],"ADULT",[118,127],{"facility":119,"status":8,"city":120,"state":121,"zip":122,"country":123,"geoPoint":124},"Research Site","Glendale","California","91206","United States",{"lat":125,"lon":126},34.14251,-118.25508,{"facility":119,"status":128,"city":129,"state":130,"zip":131,"country":123,"geoPoint":132},"NOT_YET_RECRUITING","Brooklyn","Maryland","21225",{"lat":133,"lon":134},39.23039,-76.60219,[136],{"name":137,"role":138,"phone":139,"email":140},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[],[],[],{"nct_id":4,"conditions":145,"biomarkers":146},[19],[],{"nct_id":4,"found":98,"summary":148,"prompt_version":158},{"design":149,"status":150,"heading":151,"summary":152,"follow_up":153,"word_count":154,"commitments":155,"compensation":156,"drugs_mentioned":157},"This is a Phase 1, open-label (meaning you and the study staff will know which treatment you receive), randomized study involving 152 healthy participants.","completed","A Study of Elecoglipron Formulations in Healthy Participants","This study is looking at how your body processes different oral forms of a drug called elecoglipron. Researchers want to understand how much of the drug gets into your bloodstream and how quickly, comparing a reference formulation to two new test formulations. This helps them find the best way to deliver elecoglipron. You can join if you are a healthy adult between 18 and 55 years old. For the study to be considered successful, researchers will measure the maximum amount of elecoglipron in your blood (Cmax) and how long it stays in your system (AUClast and AUCinf) over 15 days after you take the drug. The current status of this study is unclear.","You will be followed up after treatment, with drug levels measured for up to 15 days after each dose.",113,"You will have a screening visit, two treatment periods where you stay at a clinical unit and receive a single oral dose of elecoglipron, and a final follow-up visit.","Not stated in the trial record.",[],"v2"]