Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2026-02-25 @ 7:04 PM
Study NCT ID:
NCT02022306
Status:
COMPLETED
Last Update Posted:
2021-01-14
First Post:
2013-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TD-6450 SAD and MAD in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-12', 'studyFirstSubmitDate': '2013-12-17', 'studyFirstSubmitQcDate': '2013-12-20', 'lastUpdatePostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': '28 days max'}], 'secondaryOutcomes': [{'measure': 'Cmax', 'timeFrame': '28 days max', 'description': 'Pharmacokinetics'}, {'measure': 'Tmax', 'timeFrame': '28 days max', 'description': 'Pharmacokinetics'}, {'measure': 'AUC', 'timeFrame': '28 days max', 'description': 'Pharmacokinetics'}, {'measure': 'T1/2', 'timeFrame': '28 days max', 'description': 'Pharmacokinetics'}, {'measure': 'Food effect on AUC value', 'timeFrame': '15 days max', 'description': 'Measure difference between fasted and fed doses'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hepatitis C'], 'conditions': ['Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '37029122', 'type': 'DERIVED', 'citation': 'Carucci M, Duez J, Tarning J, Garcia-Barbazan I, Fricot-Monsinjon A, Sissoko A, Dumas L, Gamallo P, Beher B, Amireault P, Dussiot M, Dao M, Hull MV, McNamara CW, Roussel C, Ndour PA, Sanz LM, Gamo FJ, Buffet P. Safe drugs with high potential to block malaria transmission revealed by a spleen-mimetic screening. Nat Commun. 2023 Apr 7;14(1):1951. doi: 10.1038/s41467-023-37359-2.'}]}, 'descriptionModule': {'briefSummary': 'This study consists of two parts, Parts A and B. Part A is a single ascending dose (SAD) study in healthy subjects. Part B is a multiple ascending dose (MAD) study in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is a female of non-childbearing potential or male, who is healthy, nonsmoking, and 18 to 60 years old, inclusive, at screening. Females are considered to be of non childbearing potential if they have had a hysterectomy or tubal ligation (documentation required) or are postmenopausal (amenorrheic for at least 2 years) with a follicle stimulating hormone (FSH) level \\>40 IU/L\n* Subject has a body mass index 18 to 30 kg/m2, inclusive, and weighs at least 50 kg.\n\nExclusion Criteria:\n\n* Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.\n* Subject has an estimated creatinine clearance of \\<90 mL/min at Screening or Day -1, calculated using the Cockcroft-Gault equation.\n* Subject has participated in another clinical trial of an investigational drug (or medical device) within 60 days prior to Screening, or is currently participating in another trial of an investigational drug (or medical device).'}, 'identificationModule': {'nctId': 'NCT02022306', 'briefTitle': 'TD-6450 SAD and MAD in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Theravance Biopharma'}, 'officialTitle': 'A Double-Blinded, Randomized, Placebo-Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of TD-6450, a NS5A Inhibitor, in Healthy Subjects', 'orgStudyIdInfo': {'id': '0094'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'SAD TD-6450', 'description': 'Single ascending dose (Part A)', 'interventionNames': ['Drug: TD-6450', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'MAD TD-6450', 'description': 'Multiple ascending dose (Part B)', 'interventionNames': ['Drug: TD-6450', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Food effect of TD-6450', 'description': 'Food effect will be assessed in Part A (SAD) of this study.', 'interventionNames': ['Drug: TD-6450']}], 'interventions': [{'name': 'TD-6450', 'type': 'DRUG', 'armGroupLabels': ['Food effect of TD-6450', 'MAD TD-6450', 'SAD TD-6450']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['MAD TD-6450', 'SAD TD-6450']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'ICON Development Solutions', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Theravance Biopharma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Theravance Biopharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}