Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-04-13 @ 9:29 PM
Study NCT ID:
NCT00549666
Status:
COMPLETED
Last Update Posted:
2011-09-14
First Post:
2007-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized, Placebo-Controlled, Two-Period, Crossover Study to Evaluate the Effect of Lurasidone HCl on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069056', 'term': 'Lurasidone Hydrochloride'}, {'id': 'C109079', 'term': 'norgestimate, ethinyl estradiol drug combination'}], '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', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-12', 'studyFirstSubmitDate': '2007-10-24', 'studyFirstSubmitQcDate': '2007-10-25', 'lastUpdatePostDateStruct': {'date': '2011-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['OC DDI', 'lurasidone', 'Latuda', 'schizophenia'], 'conditions': ['Pharmacokinetics']}, 'descriptionModule': {'briefSummary': 'A Phase 1, drug, drug, interaction study between Lurasidone HCl and Ortho-tri cyclen'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is female between 18 and 40 years of age\n* Female subjects of reproductive potential will demonstrate a negative serum β-human chorionic gonadotropin level consistent with the non-gravid state at the screening visit\n* Subject agrees to take the triphasic oral contraceptive, Ortho Tri-Cyclen™, throughout the study.\n* Subject has a history of regular menstrual periods with no substantial breakthrough bleeding episodes while taking Ortho Tri-Cyclen™.\n* Subject has a body mass index that is \\< 33 kg/m2 (see Appendix 1).\n* Subject is judged to be in good health\n* Subject must have a negative hepatiti and HIV antibody at screening.\n* Subject has no clinically significant abnormality on screening ECG.\n\nExclusion Criteria:\n\n* Subject has a history of major GI abnormalities/peptic ulceration, hematological, genitourinary, cardiovascular (including hypertension), renal, hepatic, pulmonary, psychiatric, endocrine (including diabetes) or metabolic (including glaucoma), neurologic or cerebrovascular disease, or any history of cancer.\n* Subject has systolic blood pressure ≥ 140 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg at screening.\n* Subject has a history of any chronic and/or active hepatic disease including elevations of serum transaminases, hepatitis, biliary tract disease, or a history of any gastrointestinal surgery.\n* Subject has any other acute or chronic medical or psychiatric condition that, in the opinion of the investigator, would limit the patient safety or confound the results of the study.\n* Subject has an ECG at screening with PR \\> 240 msec; QRS complex \\> 120 msec; QTcB \\> 450; or any significant morphologic changes other than nonspecific T-wave changes.\n* Subject is currently a user of any illicit drugs (including "recreational use") including marijuana, or has recently used illicit drugs, or has a history of drug or alcohol dependence in the past year or abuse within the last 3 months.\n* Subject consumes excessive amounts of alcohol\n* Subject has had surgery within last 12 weeks, donated a unit of blood (within 4 weeks), or participated in another clinical study within 30 days of screening.\n* Subjects with hypertension, hyperlipidemia, and diabetes should also be excluded. (See package circular under "Contraindications")\n* Subject has clinically significant abnormalities at screening clinical examination or laboratory safety tests\n* Subject has a prolactin level of over 200 ng/mL at screening.'}, 'identificationModule': {'nctId': 'NCT00549666', 'acronym': 'OC-DDI', 'briefTitle': 'A Randomized, Placebo-Controlled, Two-Period, Crossover Study to Evaluate the Effect of Lurasidone HCl on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sumitomo Pharma America, Inc.'}, 'officialTitle': 'A Randomized, Placebo-Controlled, Two-Period, Crossover Study to Evaluate the Effect of Lurasidone HCl on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects', 'orgStudyIdInfo': {'id': 'D1050246'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lurasidone 40 mg', 'interventionNames': ['Drug: Lurasidone 40 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo 40 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ortho Tri-Cyclen', 'interventionNames': ['Drug: Ortho Tri-Cyclen']}], 'interventions': [{'name': 'Lurasidone 40 mg', 'type': 'DRUG', 'description': 'Lurasidone 40 mg days 12-21 once daily', 'armGroupLabels': ['Lurasidone 40 mg']}, {'name': 'Placebo 40 mg', 'type': 'DRUG', 'description': 'Placebo 40 mg once daily during treatment period', 'armGroupLabels': ['Placebo']}, {'name': 'Ortho Tri-Cyclen', 'type': 'DRUG', 'description': 'Ortho Tri-Cyclen during 28-day lead in period', 'armGroupLabels': ['Ortho Tri-Cyclen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Covance Global Clinical Pharmacology, Inc.', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Medical Director, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sumitomo Pharma America, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sumitomo Pharma America, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}