[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07649954":3,"trial-entities:NCT07649954":111,"trial-summary:NCT07649954":114},{"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":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":40,"secondary_outcomes":60,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":64,"eligibility_criteria":65,"std_ages":86,"locations":89,"central_contacts":99,"overall_officials":105,"references":109,"see_also_links":110},"NCT07649954","M25-472","A Study to Evaluate How Multiple Doses of Itraconazole Interacts With Nacresertib in Healthy Adult Participants","A Phase 1 Open-Label, Two-Period Study to Evaluate the Impact of Multiple Doses of Itraconazole on the Pharmacokinetics of Nacresertib in Healthy Adult Subjects","RECRUITING","2026-09","2026-07","2026-07-23","2026-06-23","AbbVie","INDUSTRY",false,"This study will evaluate how multiple doses of Itraconazole Impacts the performance of Nacresertib in healthy adult participants\n\nThe goal of this study is to assess the safety and drug to drug interaction between Itraconazole and Nacresertib.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",null,[19],"Healthy Volunteer",[19],"INTERVENTIONAL","BASIC_SCIENCE",[24],"PHASE1",{"count":26,"type":27},12,"ESTIMATED",[29,36],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","Nacresertib","Oral Tablet",[34,35],"Period 1: Nacresertib Only","Period 2: Nacresertib and Itraconazole",{"type":30,"name":37,"description":38,"armGroupLabels":39},"Itraconazole","Oral Capsule",[35],[41,45,48,51,54,57],{"measure":42,"description":43,"timeFrame":44},"Maximum Observed Plasma Concentration (Cmax) of Nacresertib","Cmax of Nacresertib","Up to Day 12",{"measure":46,"description":47,"timeFrame":44},"Time to Cmax (Tmax) of Nacresertib","Tmax of Nacresertib",{"measure":49,"description":50,"timeFrame":44},"Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of Nacresertib","AUCt of Nacresertib",{"measure":52,"description":53,"timeFrame":44},"AUC From Time 0 to the Time Infinity (AUCinf) of Nacresertib","AUCinf of Nacresertib",{"measure":55,"description":56,"timeFrame":44},"Terminal Phase Elimination Rate Constant (Beta) of Nacresertib","Beta of Nacresertib",{"measure":58,"description":59,"timeFrame":44},"Terminal Phase Elimination Half-Life (t1\u002F2) of Nacresertib","t1\u002F2 of Nacresertib",[],"ALL","18 Years","65 Years",true,{"inclusion":66,"exclusion":76,"raw_text":85},[67,68,69,70,71,72,73,74,75],"Participants must voluntarily sign and date an informed consent, approved by an IEC\u002FIRB, prior to the initiation of any screening or study-specific procedures.","Individuals 18 to 65 years of age at the time of screening.","Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg\u002Fm2 after rounding to the tenths decimal at screening. BMI is calculated as weight in kg divided by the square of height measured in meters.","A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG.","Female participants meet the following criteria.","Permanent sterility due to a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.","Non-surgical permanent infertility due to Mullerian agenesis, androgen insensitivity, or gonadal dysgenesis; investigator discretion should be applied to determining study entry.","Postmenopausal female who is age ≤ 55 years with no menses for 12 or more months without an alternative medical cause AND a follicle-stimulating hormone (FSH) level ≥ 30 IU\u002FL.","Postmenopausal female who is age \\> 55 years with no menses for 12 or more months without an alternative medical cause.",[77,78,79,80,81,82,83,84],"History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.","Participant has any clinically significant ECG abnormalities including the following:","Evidence of 2nd or 3rd degree atrioventricular (AV) block at screening visit or upon initial confinement","QT interval corrected for heart rate (QTc) using Fridericia's correction formula (QTcF) ˃ 450 msec (males) or ˃ 460 msec (females) at screening visit or upon initial confinement.","History of any clinically significant sensitivity or allergy to any medication or food.","History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption \\[e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.\\].","Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or localized carcinoma in situ of the cervix.","History or evidence of active tuberculosis (TB) disease or latent TB infection.","Inclusion Criteria:\n\n* Participants must voluntarily sign and date an informed consent, approved by an IEC\u002FIRB, prior to the initiation of any screening or study-specific procedures.\n* Individuals 18 to 65 years of age at the time of screening.\n* Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg\u002Fm2 after rounding to the tenths decimal at screening. BMI is calculated as weight in kg divided by the square of height measured in meters.\n* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG.\n* Female participants meet the following criteria.\n\nNon-Childbearing Potential due to meeting at least one of the following criteria:\n\n* Permanent sterility due to a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.\n* Non-surgical permanent infertility due to Mullerian agenesis, androgen insensitivity, or gonadal dysgenesis; investigator discretion should be applied to determining study entry.\n* Postmenopausal female who is age ≤ 55 years with no menses for 12 or more months without an alternative medical cause AND a follicle-stimulating hormone (FSH) level ≥ 30 IU\u002FL.\n* Postmenopausal female who is age \\> 55 years with no menses for 12 or more months without an alternative medical cause.\n\nExclusion Criteria:\n\n* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.\n* Participant has any clinically significant ECG abnormalities including the following:\n\n  * Evidence of 2nd or 3rd degree atrioventricular (AV) block at screening visit or upon initial confinement\n  * QT interval corrected for heart rate (QTc) using Fridericia's correction formula (QTcF) ˃ 450 msec (males) or ˃ 460 msec (females) at screening visit or upon initial confinement.\n* History of any clinically significant sensitivity or allergy to any medication or food.\n* History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption \\[e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.\\].\n* Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or localized carcinoma in situ of the cervix.\n* History or evidence of active tuberculosis (TB) disease or latent TB infection.",[87,88],"ADULT","OLDER_ADULT",[90],{"facility":91,"status":8,"city":92,"state":93,"zip":94,"country":95,"geoPoint":96},"Acpru \u002FId# 282339","Grayslake","Illinois","60030","United States",{"lat":97,"lon":98},42.34447,-88.04175,[100],{"name":101,"role":102,"phone":103,"email":104},"ABBVIE CALL CENTER","CONTACT","844-663-3742","abbvieclinicaltrials@abbvie.com",[106],{"name":107,"affiliation":13,"role":108},"ABBVIE INC.","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":112,"biomarkers":113},[19],[],{"nct_id":4,"found":64,"summary":115,"prompt_version":125},{"design":116,"status":117,"heading":118,"summary":119,"follow_up":120,"word_count":121,"commitments":122,"compensation":123,"drugs_mentioned":124},"This is an interventional study involving 12 healthy adult participants. The phase of the study is not specified.","completed","Study on Itraconazole and Nacresertib Interaction in Healthy Adults","This study is looking for healthy adult volunteers to understand how two medications, Itraconazole (an oral capsule) and Nacresertib (an oral tablet), interact with each other. The main goal is to see how Itraconazole affects the levels of Nacresertib in your body and to check for any safety concerns when taken together. Researchers will measure the highest level of Nacresertib in your blood, how long it takes to reach that level, and the overall amount of Nacresertib in your system over about 12 days. This study is currently recruiting a small group of 12 participants, aged 18 to 65, with a Body Mass Index (BMI) between 18.0 and 32.0.","The main measurements for drug levels will be taken for up to 12 days.",109,"You will attend regular visits at a hospital or clinic, which could be weekly or monthly. These visits will include medical assessments, blood tests, checking for side effects, and completing questionnaires.","Not stated in the trial record.",[31,37],"v2"]