Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-27 @ 7:33 AM
Study NCT ID:
NCT01994668
Status:
COMPLETED
Last Update Posted:
2014-03-03
First Post:
2013-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Study to Characterize the Safety and Pharmacokinetics of Single Intravenous Dose of Lorazepam in Healthy Japanese Adult Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008140', 'term': 'Lorazepam'}], 'ancestors': [{'id': 'D001570', 'term': 'Benzodiazepinones'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-28', 'studyFirstSubmitDate': '2013-11-20', 'studyFirstSubmitQcDate': '2013-11-20', 'lastUpdatePostDateStruct': {'date': '2014-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs).', 'timeFrame': 'Day 1 to Day 4', 'description': 'Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to \\[study drug\\] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': 'Day 1'}, {'measure': 'Area under the Concentration-Time Curve (AUC)', 'timeFrame': 'Day1 to Day 4', 'description': 'AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['lorazepam', 'intravenous', 'pharmacolinetics', 'healthy', 'Japanese'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3541001&StudyName=Phase%201%20Study%20to%20Characterize%20the%20Safety%20and%20Pharmacokinetics%20of%20Single%20Intravenous%20Dose%20of%20Lorazepam%20in%20Healthy%20Japanese%20Adult%20Subjects', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of 2-mg lorazepam intravenous administration in healthy Japanese adult subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Japanese male and/or female subjects of non-childbearing potential.\n* Body Mass Index of 17.5 to 30.5 kg/m2; and a total body weight \\>50 kg.\n\nExclusion Criteria:\n\n* History of sensitivity to lorazepam or other benzodiazepines.\n* Evidence or history of acute narrow-angle glaucoma or sleep apnea syndrome.\n* Significant psychiatric disorder, recurrent episodes of severe depression, or subjects with serious suicidal risk.'}, 'identificationModule': {'nctId': 'NCT01994668', 'briefTitle': 'Phase 1 Study to Characterize the Safety and Pharmacokinetics of Single Intravenous Dose of Lorazepam in Healthy Japanese Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Randomized Single-blind (Subject-blind), Placebo Controlled Study to Characterize the Safety and Pharmacokinetics of Single Intravenous Dose of Lorazepam in Healthy Japanese Adult Subjects', 'orgStudyIdInfo': {'id': 'B3541001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lorazepam', 'interventionNames': ['Drug: Lorazepam']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lorazepam', 'type': 'DRUG', 'description': 'A single intravenous administration of 2 mg lorazepam over 1 minute', 'armGroupLabels': ['Lorazepam']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'A single intravenous administration of 0.9% saline over 1 minute', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hachioji-shi', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}