Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-31 @ 9:02 AM
Study NCT ID:
NCT01074632
Status:
COMPLETED
Last Update Posted:
2011-09-08
First Post:
2010-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Calories and Fat Content on the Pharmacokinetics of Lurasidone HCl
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069056', 'term': 'Lurasidone Hydrochloride'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-06', 'studyFirstSubmitDate': '2010-02-23', 'studyFirstSubmitQcDate': '2010-02-23', 'lastUpdatePostDateStruct': {'date': '2011-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the effect of calorie and fat content on the pharmacokinetics of Lurasidone HCl in subjects with schizophrenia, schizoaffective disorder, or schizophreniform disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female 18 to 65 years of age\n* BMI \\>= 19.5 and \\<= 37 kg/m2\n* No clinically relevant abnormal laboratory values\n\nExclusion Criteria:\n\n* History or presence of renal or hepatic insufficiency\n* Participated in a clinical trial in the past 30 days\n* Use of con meds that prolong the QT/QTc taken within 14 days prior to study drug administration'}, 'identificationModule': {'nctId': 'NCT01074632', 'briefTitle': 'Effect of Calories and Fat Content on the Pharmacokinetics of Lurasidone HCl', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sumitomo Pharma America, Inc.'}, 'officialTitle': 'A Phase 1, Open-Label Study to Determine the Effect of Calories and Fat Content on the Pharmacokinetics of Repeated Dose Lurasidone 120 mg in Subjects With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder.', 'orgStudyIdInfo': {'id': 'D1050267'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Lurasidone HCl', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'California Clinical Trials', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '67207', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Clinical Research Institute', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sumitomo Pharma America, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}