Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-04-13 @ 10:27 PM
Study NCT ID:
NCT01949103
Status:
COMPLETED
Last Update Posted:
2021-01-19
First Post:
2013-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TD-1607 MAD Study in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-15', 'studyFirstSubmitDate': '2013-09-17', 'studyFirstSubmitQcDate': '2013-09-23', 'lastUpdatePostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of adverse events', 'timeFrame': '17 days', 'description': 'Adverse events'}], 'secondaryOutcomes': [{'measure': 'Cmax', 'timeFrame': '17 Days', 'description': 'Pharmacokinetics'}, {'measure': 'Tmax', 'timeFrame': '17 Days', 'description': 'Pharmacokinetics'}, {'measure': 'AUC0-t', 'timeFrame': '17 Days', 'description': 'Pharmacokinetics'}, {'measure': 'AUC0-24', 'timeFrame': '17 Days', 'description': 'Pharmacokinetics'}, {'measure': 'AUCinf', 'timeFrame': '17 Days', 'description': 'Pharmacokinetics'}, {'measure': 'CL', 'timeFrame': '17 Days', 'description': 'Pharmacokinetics'}, {'measure': 'Vdss', 'timeFrame': '17 Days', 'description': 'Pharmacokinetics'}, {'measure': 't1/2', 'timeFrame': '17 Days', 'description': 'Pharmacokinetics'}, {'measure': 'Amount excreted in urine (Ae', 'timeFrame': '17 Days', 'description': 'Pharmacokinetics'}, {'measure': 'Fraction eliminated in urine (fe)', 'timeFrame': '17 Days', 'description': 'Pharmacokinetics'}, {'measure': 'CLr', 'timeFrame': '17 Days', 'description': 'Pharmacokinetics'}, {'measure': 'Ctrough', 'timeFrame': '17 Days', 'description': 'Pharmacokinetics'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gram-positive'], 'conditions': ['Infections', 'Bacterial Infections']}, 'descriptionModule': {'briefSummary': 'TD-1607, administered intravenously as multiple ascending doses, will be investigated in healthy subjects to assess its tolerability, safety, and pharmacokinetics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is a healthy nonsmoking male or a female (of non-childbearing potential) and 18 to 55 years old, inclusive, at Screening.\n* Subject has a body mass index (BMI) of 19 to 30 kg/m2, inclusive, and weighs at least 50 kg.\n\nSubject has no clinically significant abnormalities in the results of laboratory evaluations at Screening and Day -1.\n\nExclusion Criteria:\n\n* Subject has evidence or history of clinically significant, relevant hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (except for untreated, asymptomatic seasonal allergies at time of dosing).\n* Subject has a history of allergies or hypersensitivities to glycopeptide (e.g., vancomycin) or beta-lactam (e.g., penicillin or cephalosporin) antibiotics.\n* Subject has participated in another clinical trial of an investigational drug (or medical device) within 60 days (or 5 half-lives, whichever is longer) prior to Screening or is currently participating in another trial of an investigational drug (or medical device).\n* Subject has previously participated in a trial for TD-1607.'}, 'identificationModule': {'nctId': 'NCT01949103', 'briefTitle': 'TD-1607 MAD Study in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Theravance Biopharma'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-1607, a Glycopeptide-Cephalosporin Heterodimer Antibiotic, in Healthy Subjects', 'orgStudyIdInfo': {'id': '0104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TD-1607 or placebo (Dose1)', 'description': 'TD-1607 or placebo administered intravenously', 'interventionNames': ['Drug: TD-1607', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'TD-1607 or placebo (Dose 2)', 'description': 'TD-1607 or placebo administered intravenously', 'interventionNames': ['Drug: TD-1607', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'TD-1607 or placebo (Dose 3)', 'description': 'TD-1607 or placebo administered intravenously', 'interventionNames': ['Drug: TD-1607', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'TD-1607 or placebo (Dose 4)', 'description': 'TD-1607 or placebo administered intravenously', 'interventionNames': ['Drug: TD-1607', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'TD-1607 or placebo (Dose 5) [Optional]', 'description': 'TD-1607 or placebo administered intravenously', 'interventionNames': ['Drug: TD-1607', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'TD-1607 or placebo (Dose 6) [Optional]', 'description': 'TD-1607 or placebo administered intravenously', 'interventionNames': ['Drug: TD-1607', 'Drug: Placebo']}], 'interventions': [{'name': 'TD-1607', 'type': 'DRUG', 'armGroupLabels': ['TD-1607 or placebo (Dose 2)', 'TD-1607 or placebo (Dose 3)', 'TD-1607 or placebo (Dose 4)', 'TD-1607 or placebo (Dose 5) [Optional]', 'TD-1607 or placebo (Dose 6) [Optional]', 'TD-1607 or placebo (Dose1)']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['TD-1607 or placebo (Dose 2)', 'TD-1607 or placebo (Dose 3)', 'TD-1607 or placebo (Dose 4)', 'TD-1607 or placebo (Dose 5) [Optional]', 'TD-1607 or placebo (Dose 6) [Optional]', 'TD-1607 or placebo (Dose1)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'PPD, Phase 1 Clinic', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Theravance Biopharma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Theravance Biopharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}