[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07377539":3,"trial-entities:NCT07377539":107,"trial-summary:NCT07377539":111},{"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":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":41,"secondary_outcomes":69,"sex":78,"minimum_age":79,"maximum_age":80,"healthy_volunteers":81,"eligibility_criteria":82,"std_ages":86,"locations":88,"central_contacts":98,"overall_officials":104,"references":105,"see_also_links":106},"NCT07377539","JZP047-101","A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of JZP047 in Healthy Participants","A Double-Blind, Sponsor-Unblinded, Randomized, Placebo-Controlled Study of the Safety, Tolerability, and Pharmacokinetics of Single-Ascending Doses of JZP047 and an Open-Label Food Effect Study of JZP047 in Healthy Male and Female Participants","RECRUITING","2026-07-05","2026-04","2026-04-20","2026-02-03","Jazz Pharmaceuticals","INDUSTRY",false,"This is a Phase 1, double-blind, sponsor-unblinded, randomized, placebo-controlled study designed to characterize the safety, tolerability, and PK of JZP047 in healthy participants following single-ascending doses of study intervention. Additionally, the effect of food on PK following a single dose of JZP047 will be assessed through comparison of PK between the fed and fasted states.","The study will consist of 2 parts: a single-dose ascending part (Part A \\[SAD\\] and a single dose under fed conditions part (Part B \\[Fed PK\\]).\n\nThe study design for Part A will be double-blind, sponsor-unblinded, randomized, and placebo-controlled. Part B, the single dose under fed conditions, will have an open-label study design.\n\nPart A will characterize safety, tolerability, and PK following single doses of JZP047 and matching placebo in healthy male and female participants. Part B will explore the effect of food on a single dose of JZP047 in healthy male and female participants in the fed state.",[19],"Healthy Participants",[19,21],"JZP047","INTERVENTIONAL","TREATMENT",[25],"PHASE1",{"count":27,"type":28},86,"ESTIMATED",[30,36],{"type":31,"name":21,"description":32,"armGroupLabels":33},"DRUG","Single dose",[34,35],"Part A: JZP047","Part B: JZP047",{"type":37,"name":38,"description":32,"armGroupLabels":39},"OTHER","Placebo",[40],"Part A: Placebo",[42,45,47,49,51,54,56,58,60,62,64,67],{"measure":43,"timeFrame":44},"Number of Participants Reporting Treatment-emergent Adverse Events (Part A)","Baseline up to Day 90",{"measure":46,"timeFrame":44},"Number of Participants Reporting Treatment-emergent Adverse Events (Part B)",{"measure":48,"timeFrame":44},"Number of Participants Who Discontinued The Study (Part A)",{"measure":50,"timeFrame":44},"Number of Participants Who Discontinued The Study (Part B)",{"measure":52,"timeFrame":53},"Pharmacokinetic Parameter Maximum Concentration (Part A)","Up to 90 days",{"measure":55,"timeFrame":53},"Pharmacokinetic Parameter Time to Maximum Concentration and Time Before the Start of Absorption (Part A)",{"measure":57,"timeFrame":53},"Pharmacokinetic Parameter Terminal Elimination Half-life (Part A)",{"measure":59,"timeFrame":53},"Pharmacokinetic Parameter Terminal Elimination Rate Constant (Part A)",{"measure":61,"timeFrame":53},"Pharmacokinetic Parameter Volume of Distribution During Terminal Phase (Part A)",{"measure":63,"timeFrame":53},"Pharmacokinetic Parameter Oral Clearance (Part A)",{"measure":65,"description":66,"timeFrame":53},"Pharmacokinetic Parameter Area Under the Concentration-Time Curve (Part A)","Area under the concentration-time curve from time 0 to 24 (AUC0-24), 0 to last measurable concentration (AUClast), and 0 to infinity (AUC∞) will be assessed.",{"measure":68,"timeFrame":53},"Pharmacokinetic Parameter Percentage of The Area Under the Concentration-Time Curve From Time Infinity Due to Extrapolation From The Last Quantifiable Concentration to Time Infinity (Part A)",[70,72,74,76],{"measure":71,"timeFrame":53},"Dose Proportionality of JZP047 Cmax (Part A)",{"measure":73,"timeFrame":53},"Dose Proportionality of JZP047 AUC0-last and AUC∞",{"measure":75,"timeFrame":53},"The Effect of Food On The Single Dose PK of JZP047 Cmax",{"measure":77,"timeFrame":53},"The Effect of Food On The Single Dose PK of JZP047 AUC0-last and AUC∞","ALL","18 Years","55 Years",true,{"inclusion":83,"exclusion":84,"raw_text":85},[],[],"Participants are eligible to be included in the study only if all of the following criteria apply:\n\n1. Healthy participants 18 to 55 years of age, willing and able to comply with study requirements.\n2. Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 120 days after the last dose of study intervention:\n\n   * Refrain from donating sperm.\n   * Use contraception\u002Fbarrier as follows:\n\n     * Use a male condom with female partner and use of an additional highly effective contraceptive method with a failure rate of \\\u003C 1% per year and should also be advised of the benefit of a female partner using a highly effective method of contraception, as a condom may break or leak, when having sexual intercourse with a woman of childbearing potential (WOCBP) who is currently not pregnant.\n     * Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person.\n3. Female participants are eligible to participate if:\n\n   * She is a woman of nonchildbearing potential (WONCBP).\n   * Pregnancy testing will be performed prior to administration of study intervention to confirm female participants are not pregnant.\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. History of or presence of clinically significant medical illness or disorder or have a medical issue that may interfere with absorption, distribution, metabolism, or excretion of drugs..\n2. History or presence of clinically significant allergy (other than seasonal allergies that do not require treatment during the study) or clinically significant allergy to adhesive bandages, adhesive dressing, ECG patches, or medical tape.\n3. History (within 5 past years) or presence of a diagnosis of alcohol abuse, a substance abuse disorder, known drug dependence, or seeking of treatment for an alcohol- or substance abuse-related disorder.\n4. Current diagnosis of or receiving treatment for depression; past (within 5 years) clinically significant major depressive episode.\n5. History of suicide attempt, current suicidal risk as determined from history, or presence of active suicidal ideation.\n6. Presence of any other condition that will cause a risk to participants if they participate in the study as determined by the investigator.\n7. Poor peripheral venous access or history of fainting (or passing out) during blood draws.\n8. Use or intent to use any prescription medications or nonprescription drugs (including vitamins, recreational drugs, and dietary or herbal supplements) within 14 days or for 5 half-lives, whichever is longer prior to Check-in and throughout the conduct of the study.",[87],"ADULT",[89],{"facility":90,"status":8,"city":91,"state":92,"zip":93,"country":94,"geoPoint":95},"Celerion, Inc.","Lincoln","Nebraska","68502","United States",{"lat":96,"lon":97},40.8,-96.66696,[99],{"name":100,"role":101,"phone":102,"email":103},"Clinical Trial Disclosure & Transparency","CONTACT","215-832-3750","ClinicalTrialDisclosure@JazzPharma.com",[],[],[],{"nct_id":4,"conditions":108,"biomarkers":110},[109],"Healthy",[],{"nct_id":4,"found":81,"summary":112,"prompt_version":122},{"design":113,"status":114,"heading":115,"summary":116,"follow_up":117,"word_count":118,"commitments":119,"compensation":120,"drugs_mentioned":121},"This is a Phase 1 study, meaning it's an early-stage study in humans. It is designed as a randomized, placebo-controlled study, with some parts being double-blind (neither you nor the study staff know if you're getting JZP047 or a placebo) and other parts open-label (everyone knows what you're getting).","completed","A Study of JZP047 in Healthy Participants","This study is looking at a drug called JZP047. It aims to understand how safe JZP047 is, how well your body tolerates it, and how your body processes it (pharmacokinetics or PK). Researchers will also see how food affects JZP047 in your body. You might be eligible if you are a healthy person between 18 and 55 years old. The main goals are to track any side effects and how many people leave the study. This study is currently unclear on its recruitment status and plans to enroll 86 participants.","You would be followed for up to 90 days after your last dose of the study intervention to monitor for any side effects.",90,"Not specified in the trial record.","Not stated in the trial record.",[21],"v2"]