[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Akyso Therapeutics, LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":50},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":5},"100597905","phase-1-istep-n-101b-pharmacokinetics-and-safety-study-of-low--and-high-dose-naltrexone-implants-vs-monthly-vivitrol-in-healthy-volunteers-100597905",false,"NCT07064564","iSTEP-N 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteers","A Randomized, Active-comparator Controlled, Two-Dose-level Study of iSTEP-N in Healthy Adults With Long Term Safety and PK Follow-up","iSTEP-N","Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be eligible for the study:\n\nHealthy adult male or female volunteers, ages 18 to 55 years.\n\nAble and willing to provide written informed consent prior to any study procedures.\n\nIn good general health as determined by medical history, physical examination, vital signs, ECG, and laboratory tests (chemistry, hematology, and coagulation).\n\nNo clinically significant abnormalities in lab results, as determined by the investigator.\n\nNegative urine drug screen for opioids, cocaine, amphetamines, benzodiazepines, cannabinoids, and other substances of abuse.\n\nNegative breath alcohol test at screening and baseline.\n\nNegative naloxone challenge test, indicating no physiological opioid dependence.\n\nFor females of childbearing potential:\n\nNegative serum pregnancy test at screening and Day 0.\n\nAgreement to use acceptable contraception (including oral hormonal contraception) for the duration of the study.\n\nFor males with female partners of childbearing potential:\n\nAgreement to use effective contraception throughout the study.\n\nNegative infectious disease panel, including HIV, hepatitis B surface antigen, and hepatitis C antibody.\n\nNo evidence of suicidal ideation or behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening.\n\nHamilton Depression Rating Scale (HAM-D17) total score of 0 to 10, consistent with no or minimal depressive symptoms.\n\nWilling and able to comply with all study visits, procedures, and restrictions, including pharmacokinetic sampling.\n\nWilling to refrain from donating blood during the study period.\n\nAgree not to use opioid-containing medications for the duration of the study unless medically necessary and approved by the investigator.\n\nExclusion Criteria:\n\nParticipants who meet any of the following conditions will be excluded:\n\nCurrent or recent history (past 12 months) of opioid use disorder, substance use disorder, or alcohol dependence.\n\nPositive urine drug test or breath alcohol test at screening or prior to randomization.\n\nFailure of the naloxone challenge test, indicating possible physical opioid dependence.\n\nUse of any investigational drug or device within 30 days prior to screening.\n\nUse of any opioid-containing medications (prescription or OTC) within 14 days prior to screening.\n\nKnown hypersensitivity or allergy to naltrexone, polycaprolactone (PCL), polylactic acid (PLA), polymeric implants, or any other component of the study drug.\n\nHistory of chronic pain, neurological or psychiatric disorders, or any condition requiring regular use of medications.\n\nActive medical condition or past medical history that, in the opinion of the investigator, could interfere with the study or pose an undue risk, including:\n\nCardiovascular disease\n\nHepatic or renal impairment\n\nGastrointestinal disorders affecting absorption\n\nRespiratory disease\n\nSeizure disorder\n\nAutoimmune or inflammatory disorders\n\nFemales who are pregnant, breastfeeding, or planning to become pregnant during the study period.\n\nBaseline systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg.\n\nHistory of major depressive disorder, bipolar disorder, psychosis, or other severe psychiatric illness.\n\nHAM-D17 score \\>10 at screening or Day 0.\n\nAny suicidal ideation or behavior as defined by the C-SSRS in the past 6 months.\n\nParticipation in another clinical trial with investigational medication or device within the past 30 days.\n\nKnown coagulation disorder or current use of anticoagulants.\n\nInability to comply with study procedures due to geographic, social, or mental limitations.\n\nPresence of any implantable medical device that may interfere with study procedures or assessments.\n\nHistory of keloid formation or abnormal wound healing, which may affect implant insertion site.\n\nHistory of HIV, hepatitis B, or hepatitis C, unless determined to be false positive or clinically insignificant by the investigator.\n\nAny condition that, in the investigator's opinion, would make the subject unsuitable for the study.",true,"ALL","18 Years","65 Years",{"count":22,"type":23},33,"ESTIMATED","INTERVENTIONAL",[26],"PHASE1","This Phase 1b clinical study is evaluating iSTEP-N, an investigational extended-release implant containing naltrexone, a medication used to block the effects of opioids. The implant is placed under the skin of the thigh and is designed to release medication continuously over many months.\n\nThe main purpose of the study is to measure blood levels of naltrexone over time after administration of two different doses of the iSTEP-N implant and to compare those levels with the blood levels achieved by Vivitrol®, an FDA-approved injectable extended-release naltrexone given once every month.\n\nThe study will enroll healthy adult volunteers aged 18 to 65 years. Participants will be randomly assigned to one of three groups:\n\n* Low-dose iSTEP-N implant\n* High-dose iSTEP-N implant\n* Monthly Vivitrol injections\n\nParticipants will be followed closely for approximately 12 months to measure medication levels and monitor safety, side effects, and overall health. The study will help determine whether the iSTEP-N implant can maintain naltrexone levels comparable to or higher than those achieved with monthly injections, especially during periods when protection from relapse is most important.\n\nParticipants who receive an iSTEP-N implant and still have detectable implant material or measurable medication levels at the end of the first year may continue in a long-term follow-up period lasting up to two additional years. During this period, researchers will monitor how long the implant remains detectable and how long medication continues to be released. If the implant remains after two years, participants may choose to have it surgically removed or simply end study participation.\n\nThe study is sponsored by Akyso Therapeutics, LLC, with clinical operations conducted at a dedicated clinical research center and oversight provided by an independent Institutional Review Board. All participants undergo screening examinations to confirm eligibility and are carefully monitored throughout participation.\n\nResults from this study will help determine the appropriate dose of iSTEP-N for future clinical trials and support development of long-acting treatment options for opioid use disorder that may reduce the need for frequent injections.",[29],"Opioid Use Disorder",[31,32,33,34,35,36,37],"naltrexone","biopin","oud","implant","opioid use disorder","extended-release","vivtrol","RECRUITING","2026-07-28",{"date":41,"type":42},"2026-07-30","ACTUAL",{"date":44,"type":42},"2026-07-25",{"date":46,"type":23},"2029-12-31",{"name":48,"class":49},"Akyso Therapeutics, LLC","INDUSTRY",""]