[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100181600":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":27,"centralContacts":23,"locations":40,"responsibleParty":54,"collaborators":56,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":23,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":82,"whyStopped":23,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"CTI BioPharma","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment A","EXPERIMENTAL","Two 60 mg capsules (120 mg dose) of CHR-2797 administered orally with 240 mL room temperature tap water after an approximately 10 hour fast.",[13],"Drug: CHR-2797",{"label":15,"type":10,"description":16,"interventionNames":17},"Treatment B","Two 60 mg capsules (120 mg dose) of CHR-2792 administered orally with 240 mL room temperature tap water within 30 minutes of receiving a high-fat meal.",[13],[19,24],{"type":20,"name":21,"description":11,"armGroupLabels":22,"otherNames":23},"DRUG","CHR-2797",[9],null,{"type":20,"name":21,"description":25,"armGroupLabels":26,"otherNames":23},"Two 60 mg capsules (120 mg dose) of CHR-2792 administered orally with 240 mL room temperature tap water within 30 minutes of receiving a high-fat meal.\n\n\\--------------------------------------------------------------------------------",[15],[28,32,35,38],{"name":29,"affiliation":30,"role":31},"Randall Stoltz, MD","Covance","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":5,"role":34},"Simran Singh, MS, GWCPM","STUDY_CHAIR",{"name":36,"affiliation":30,"role":37},"Bob Wright, PM","STUDY_DIRECTOR",{"name":39,"affiliation":5,"role":37},"Jack Singer, MD",[41],{"facility":42,"status":23,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":23},"Covance Clinical Research Unit Inc.","Evansville","Indiana","47710","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-87.55585,37.97476,{"lat":52,"lon":51},{"type":55,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[57],{"name":58,"class":6},"Chroma Therapeutics","100181600","phase-1-crossover-trial-of-the-effect-of-a-high-fat-meal-on-the-pk-of-oral-chr-2797-in-healthy-male-subjects-100181600",false,"NCT01638442","Crossover Trial of the Effect of a High-Fat Meal on the PK of Oral CHR 2797 in Healthy Male Subjects","An Open-label, Randomized, Two-way Crossover Trial of the Effect of a High-Fat Meal on the Pharmacokinetics of Oral Tosedostat (CHR 2797) in Healthy Male Subjects","8265134","Inclusion Criteria:\n\n1. Male subjects between 18 and 55 years of age, inclusive.\n2. Within BMI range of 18.5 to 29.9 kg\u002Fm2, inclusive.\n3. In good health, determined by no clinically significant ongoing diseases or other conditions that require medication, and\u002For any other findings from medical history, physical examination, 12-lead ECG, and vital signs.\n4. Clinical laboratory evaluations (including chemistry panel fasted \\[fasted approximately 10 hours\\], CBC, and UA) within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator.\n5. Negative test for selected drugs of abuse at Screening (does not include alcohol) and at Check-in (does include alcohol; Appendix A).\n6. Negative hepatitis panel (including hepatitis B surface antigen \\[HBsAg\\] and hepatitis C virus \\[anti-HCV\\], and negative HIV antibody screens (Appendix A);\n7. Males will either be sterile or agree to use 1 of the following approved methods of contraception: a male condom with spermicide; a sterile sexual partner; use by female sexual partner of an intrauterine device with spermicide; a female condom with spermicide; contraceptive sponge with spermicide; an intravaginal system (e.g., NuvaRing®), a diaphragm with spermicide; a cervical cap with spermicide; or oral, implantable, transdermal, or injectable contraceptives from Check-in (Day -1 of Period 1) until 90 days following Clinic Discharge (Day 10).\n8. Able to comprehend and willing to sign an Informed Consent Form (ICF).\n\nExclusion Criteria:\n\n1. Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator).\n2. Have a disease or condition that requires daily medication.\n3. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator.\n4. History of stomach or intestinal surgery or resection that would potentially alter absorption and\u002For excretion of orally administered drugs (except that appendectomy, hernia repair, and\u002For cholecystectomy will be allowed).\n5. History or presence of an abnormal ECG, which, in the Investigator's opinion, is clinically significant.\n6. History of alcoholism or drug addiction within 1 year prior to Check-in (Day -1 of Period 1).\n7. Use of any tobacco- or nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to Check-in (Day -1 of Period 1).\n8. Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days prior to Check-in (Day -1 of Period 1).\n9. Use of any prescription medications\u002Fproducts within 14 days prior to Check-in (Day 1 of Period 1), unless deemed acceptable by the Investigator;\n10. Use of any over-the-counter (OTC), non-prescription preparations (including vitamins, minerals, and phytotherapeutic\u002Fherbal\u002Fplant-derived preparations) within 7 days prior to Check-in (Day -1 of Period 1), unless deemed acceptable by the Investigator.\n11. Use of alcohol-, grapefruit-, or caffeine-containing foods or beverages within 72 hours prior to Check-in (Day -1 of Period 1), unless deemed acceptable by the Investigator.\n12. Poor peripheral venous access.\n13. Donation of blood from 30 days prior to Screening through Study Completion, inclusive, or of plasma from 2 weeks prior to Screening through Study Completion, inclusive.\n14. Receipt of blood products within 2 months prior to Check-in (Day -1 of Period 1).\n15. Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject's ability to complete and\u002For participate in this clinical study.",true,"MALE","18 Years","55 Years",{"count":72,"type":73},18,"ACTUAL","INTERVENTIONAL",[76],"PHASE1","The objectives of this study are to evaluate the safety and tolerability; and to determine the effect of food on the pharmacokinetics (PK) of CHR-2797 in normal healthy male subjects.",[79],"Healthy",[81],"Male subjects, healthy","COMPLETED","2023-09-14",{"date":85,"type":73},"2023-09-18",{"date":87,"type":23},"2012-06",{"date":89,"type":73},"2012-09",{"name":5,"class":6},1]