Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-01-11 @ 3:35 PM
Study NCT ID:
NCT03103412
Status:
COMPLETED
Last Update Posted:
2021-01-14
First Post:
2017-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2017-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-12', 'studyFirstSubmitDate': '2017-03-24', 'studyFirstSubmitQcDate': '2017-03-31', 'lastUpdatePostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety & tolerability of TD-3504 by assessing the number, severity, and type of adverse events', 'timeFrame': 'Day 1 through Day 8', 'description': 'To assess the safety \\& tolerability of TD-3504 following single escalating doses of TD-3504 co-administered with a low dose of 15N2 tofacitinib for 8 days in healthy subjects and subjects with UC by assessing the number, severity, and type of treatment related adverse events.'}], 'secondaryOutcomes': [{'measure': 'Safety & tolerability of TD-3504 by assessing treatment related changes safety laboratory values', 'timeFrame': 'Day 1 through Day 8', 'description': 'To assess the safety \\& tolerability of TD-3504 following single escalating doses of TD-3504 co-administered with a low dose of 15N2 tofacitinib for 8 days in healthy subjects and subjects with UC by assessing treatment related changes safety laboratory values.'}, {'measure': 'Systemic area under the curve of TD-3504', 'timeFrame': 'Day 1 through Day 4', 'description': 'To assess the systemic exposure of TD-3504 following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.'}, {'measure': 'Systemic Cmax of TD-3504', 'timeFrame': 'Day 1', 'description': 'To assess the systemic exposure of TD-3504 following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.'}, {'measure': 'Systemic area under the curve of tofacitinib', 'timeFrame': 'Day 1 through Day 4', 'description': 'To assess the systemic exposure of tofacitinib following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.'}, {'measure': 'Systemic Cmax of tofacitinib', 'timeFrame': 'Day 1', 'description': 'To assess the systemic exposure of tofacitinib following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.'}, {'measure': 'Systemic area under the curve of 15N2-tofacitinib', 'timeFrame': 'Day 1 through Day 4', 'description': 'To assess the systemic exposure of following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.'}, {'measure': 'Systemic Cmax of 15N2-tofacitinib', 'timeFrame': 'Day 1', 'description': 'To assess the systemic exposure of following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.'}, {'measure': 'Tofacitinib relative bioavailability by area under the curve comparison', 'timeFrame': 'Day 1 through Day 4', 'description': 'To assess the relative bioavailability of tofacitinib from TD-3504 relative to 15N2-tofacitinib.'}, {'measure': 'Tofacitinib relative bioavailability by Cmax comparison', 'timeFrame': 'Day 1', 'description': 'To assess the relative bioavailability of tofacitinib from TD-3504 relative to 15N2-tofacitinib.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects'], 'conditions': ['Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single-dose TD-3504 and single dose 15N2-tofacitinib in healthy subjects and subjects with UC. The relative bioavailability of tofacitinib released from TD-3504 compared to co-administered oral heavy-labeled tofacitinib (15N2-tofacitinib) will also be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female between 18 to 55 years old\n* Male subjects must abstain from sexual intercourse or use a highly effective method of birth control\n* Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use a highly effective method of birth control\n* Body Mass Index (BMI) 18 to 32 kg/m2\n* Willing and able to give informed consent\n* Additional inclusion criteria apply\n\nInclusion Criteria for Ulcerative Colitis (UC) subjects:\n\n* Subject has a history of UC\n* Subject is either not taking any medication for UC or has been taking a stable dose of ulcerative colitis medications for ≥ 14 days\n* Additional inclusion criteria apply\n\nExclusion Criteria:\n\n* Is positive for hepatitis A, B or C, HIV or tuberculosis\n* Has clinically significant abnormalities in baseline laboratory evaluations\n* Subject has a clinically significant abnormal electrocardiogram (ECG)\n* Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to screening (or within 60 days prior to screening if investigational drug was a biologic, or is currently participating in another trial of an investigational drug (or medical device)\n* Additional exclusion criteria apply\n\nExclusion Criteria for Healthy Subjects:\n\n* Use of prescription drugs or any chronic over the counter medications within 14 days prior to clinic admission or requires continuing use during study participation, with the exception of hormonal contraceptives or hormone replacement therapy or standard daily multivitamin.\n* Additional exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT03103412', 'briefTitle': 'TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Theravance Biopharma'}, 'officialTitle': 'Study 0146: A Phase 1a, Double-Blinded, Randomized, Placebo Controlled, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, and Systemic Exposure of TD-3504 in Healthy Subjects and Subjects With Ulcerative Colitis (UC)', 'orgStudyIdInfo': {'id': '0146'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TD-3504 Low-Dose', 'description': '6 healthy subjects and 6 ulcerative colitis subjects will be randomized to receive low-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose.', 'interventionNames': ['Drug: TD-3504', 'Drug: 15N2-tofacitinib']}, {'type': 'EXPERIMENTAL', 'label': 'TD-3504 Mid-Dose', 'description': '6 healthy subjects will be randomized to receive mid-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose.', 'interventionNames': ['Drug: TD-3504', 'Drug: 15N2-tofacitinib']}, {'type': 'EXPERIMENTAL', 'label': 'TD-3504 High-Dose', 'description': '6 healthy subjects will be randomized to receive high-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose.', 'interventionNames': ['Drug: TD-3504', 'Drug: 15N2-tofacitinib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '6 healthy subjects and 2 ulcerative colitis subjects to receive placebo orally single dose.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'TD-3504', 'type': 'DRUG', 'description': 'TD-3504', 'armGroupLabels': ['TD-3504 High-Dose', 'TD-3504 Low-Dose', 'TD-3504 Mid-Dose']}, {'name': '15N2-tofacitinib', 'type': 'DRUG', 'description': '15N2-tofacitinib', 'armGroupLabels': ['TD-3504 High-Dose', 'TD-3504 Low-Dose', 'TD-3504 Mid-Dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Anaheim Clinical Trials, LLC', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Theravance Biopharma'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Theravance Biopharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}