[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643598":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":18,"centralContacts":19,"locations":18,"responsibleParty":25,"collaborators":18,"id":27,"slug":28,"hasResults":29,"nctId":30,"briefTitle":31,"officialTitle":32,"acronym":18,"eligibilityCriteria":33,"healthyVolunteers":29,"sex":34,"minAge":35,"maxAge":36,"enrollmentInfo":37,"targetDuration":18,"studyType":40,"phases":41,"briefSummary":43,"conditions":44,"keywords":18,"overallStatus":46,"whyStopped":18,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":18},{"fullName":5,"class":6},"Inhibikase Therapeutics","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"IKT-001","EXPERIMENTAL","IKT-001 tablets for PO administration",[13],"Drug: IKT-001",[15],{"type":16,"name":9,"description":11,"armGroupLabels":17,"otherNames":18},"DRUG",[9],null,[20],{"name":21,"role":22,"phone":23,"phoneExt":18,"email":24},"Medical Director, Inhibikase Therapeutics","CONTACT","1-302-295-3800","info@inhibikase.com",{"type":26,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100643598","phase-3-open-label-study-of-ikt-001-in-pulmonary-arterial-hypertension-pah-100643598",false,"NCT07632898","Open-Label Study of IKT-001 in Pulmonary Arterial Hypertension (PAH)","Open-Label, Long-Term Extension Study to Evaluate the Safety and Tolerability of IKT-001 in Pulmonary Arterial Hypertension","Inclusion Criteria:\n\n* Capable of giving signed informed consent.\n* Participants who have completed Study IKT-001-201 or any other Phase 2 or 3 controlled clinical study with IKT-001.\n\nExclusion Criteria:\n\n* Any of the following clinical laboratory values at screening:\n\n  * ALT or AST levels \\>3× the ULN\n  * Bilirubin levels \\>2× the ULN\n  * ANC \\\u003C1.2 ×10\\^9 cells\u002FL, hemoglobin \\\u003C9 g\u002FdL, hematocrit \\\u003C30%, or platelets \\\u003C75 × 10\\^9 cells\u002FL\n  * Absolute eGFR \\\u003C30 mL\u002Fmin using creatinine or cystatin C as defined by the CKD-EPI equation (2021)\n* Currently lactating, pregnant or planning on becoming pregnant during the study.\n* Receiving treatment with sotatercept.","ALL","18 Years","75 Years",{"count":38,"type":39},484,"ESTIMATED","INTERVENTIONAL",[42],"PHASE3","This is a multicenter, open-label extension (OLE), single-arm study designed to assess the long-term safety and tolerability of oral IKT-001 administered once daily.",[45],"Pulmonary Arterial Hypertension (PAH)","NOT_YET_RECRUITING","2026-06-02",{"date":49,"type":50},"2026-06-08","ACTUAL",{"date":52,"type":39},"2026-10-23",{"date":54,"type":39},"2030-12-30",{"name":5,"class":6}]