Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2026-02-06 @ 3:56 PM
Study NCT ID:
NCT02903095
Status:
COMPLETED
Last Update Posted:
2021-01-19
First Post:
2016-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Ascending Dose Study of TD-1439 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-15', 'studyFirstSubmitDate': '2016-09-08', 'studyFirstSubmitQcDate': '2016-09-12', 'lastUpdatePostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of TD-1439 by assessing the number and severity of adverse events, including changes in vital signs, physical examination, laboratory safety tests, and ECGs', 'timeFrame': 'From Day 1 through end of study (Day 10)'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK) of TD-1439 in plasma after multiple doses - peak plasma concentration (Cmax)', 'timeFrame': 'Day 1 through Day 10'}, {'measure': 'PK of TD-1439 in plasma after multiple doses - time to peak plasma concentration (Tmax)', 'timeFrame': 'Day 1 through Day 10'}, {'measure': 'PK of TD-1439 in plasma after multiple doses - time to last measurable concentration (Tlast)', 'timeFrame': 'Day 1 through Day 10'}, {'measure': 'PK of TD-1439 in plasma after multiple doses - area under the plasma concentration vs. time curve from time zero to the last quantifiable concentration (AUC0-t)', 'timeFrame': 'Day 1 through Day 10'}, {'measure': 'PK of TD-1439 in plasma after multiple doses - area under the plasma concentration vs. time curve from time zero to 24 hours postdose (AUC0-24)', 'timeFrame': 'Day 1 through Day 10'}, {'measure': 'PK of TD-1439 in plasma after multiple doses - CL/F (oral plasma clearance)', 'timeFrame': 'Day 1 through Day 10'}, {'measure': 'PK of TD-1439 in plasma after multiple doses - Vz/F (apparent volume of distribution during the terminal phase)', 'timeFrame': 'Day 1 through Day 10'}, {'measure': 'PK of TD-1439 in plasma after multiple doses - t1/2 (half-life)', 'timeFrame': 'Day 1 through Day 10'}, {'measure': 'PK of TD-1439 in urine after multiple doses - Ae (amount excreted in urine)', 'timeFrame': 'Day 1 through Day 10'}, {'measure': 'PK of TD-1439 in urine after multiple doses - Fe (fraction of oral dose excreted in urine)', 'timeFrame': 'Day 1 through Day 10'}, {'measure': 'PK of TD-1439 in urine after multiple doses - Clr (renal clearance)', 'timeFrame': 'Day 1 through Day 10'}, {'measure': 'Pharmacodynamic assessments for plasma atrial natriuretic peptide (ANP) concentrations', 'timeFrame': 'The day before dosing (Day -1) to 3 days after last dose (Day 4)'}, {'measure': 'Pharmacodynamic assessments for urine atrial natriuretic peptide (ANP) concentrations', 'timeFrame': 'The day before dosing (Day -1) to 3 days after last dose (Day 4)'}, {'measure': 'Pharmacodynamic assessments for plasma cyclic guanosine monophosphate (cGMP) concentrations', 'timeFrame': 'The day before dosing (Day -1) to 3 days after last dose (Day 4)'}, {'measure': 'Pharmacodynamic assessments for urine cyclic guanosine monophosphate (cGMP) concentrations', 'timeFrame': 'The day before dosing (Day -1) to 3 days after last dose (Day 4)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Single ascending dose'], 'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-1439 in healthy subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index (BMI) 18 to 32 kg/m2 inclusive\n* Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use highly effective methods of birth control\n* Women of non-childbearing potential are at least 2 years postmenopausal or are surgically sterile\n* Males must abstain from sex or use highly effective methods of birth control\n* Negative for HIV, and Hepatitis A, B, and C\n\nExclusion Criteria:\n\n* Female subjects who are pregnant, lactating, breastfeeding or planning to become pregnant during the study.\n* Subjects with a history of angioedema.\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 acute illness (gastrointestinal, infection \\[e.g., influenza\\] or known inflammatory process)\n* Subject bradycardia\n* Subject has hypertension\n* Subjects has orthostatic hypotension\n* Subjects has orthostatic tachycardia\n* Subject has a known personal or family history of congenital long QT syndrome or known family history of sudden death.\n* Subject has donated blood or blood components or has had blood loss exceeding 400 mL within the 90 days prior to Screening.\n* Additional exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT02903095', 'briefTitle': 'Single Ascending Dose Study of TD-1439 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Theravance Biopharma'}, 'officialTitle': 'A Phase 1, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TD-1439 in Healthy Subjects', 'orgStudyIdInfo': {'id': '0147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TD-1439', 'description': 'Capsule formulation', 'interventionNames': ['Drug: TD-1439']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Capsule formulation', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'TD-1439', 'type': 'DRUG', 'armGroupLabels': ['TD-1439']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68502', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Celerion', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}], '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'}}}}