Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-01-04 @ 10:05 AM
Study NCT ID:
NCT03724292
Status:
COMPLETED
Last Update Posted:
2018-10-30
First Post:
2018-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Ascending Multiple Dose Study With VTP-43742 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000615700', 'term': 'VTP-43742'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2016-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-26', 'studyFirstSubmitDate': '2018-10-26', 'studyFirstSubmitQcDate': '2018-10-26', 'lastUpdatePostDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-emergent adverse events (TEAEs) in the healthy volunteer (Part 1) group', 'timeFrame': 'Study Day 1 to Day 17±2 (follow up)'}], 'secondaryOutcomes': [{'measure': 'Maximum plasma concentration (Cmax) in the healthy volunteer (Part 1) group', 'timeFrame': 'Day 1 and Day 10'}, {'measure': 'Time to maximum plasma concentrations (tmax) in the healthy volunteer (Part 1) group', 'timeFrame': 'Day 1 and Day 10'}, {'measure': 'The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration (AUCt) in the healthy volunteer (Part 1) group', 'timeFrame': 'Day 1 and Day 10'}, {'measure': 'Half life (t½) in the healthy volunteer (Part 1) group', 'timeFrame': 'Day 10 to Day 13 (72 hours)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Moderate to severe chronic plaque-type psoriasis'], 'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'This is Part 1 of a two-part, randomized, double-blind, placebo-controlled study in which VTP-43742 was administered to participants; Part 1 in healthy volunteers and Part 2 in psoriatic participants.', 'detailedDescription': 'This was a prospective, randomized, double-blind, placebo-controlled, ascending multiple dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics effects of VTP-43742 in healthy volunteers conducted at a single, study center in the United States (Part 1). A total of 74 participants were enrolled both parts of the study (Part 1 with 40 healthy subjects; Part 2 with 34 psoriatic participants). This post includes data from Part 1 of the study only; Part 2 is reported separately.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males or females, 18 to 45 years of age, inclusive.\n* Body weight of at least 55 kg and body mass index of 18-32 kg/m2, inclusive.\n* Medically healthy with clinically insignificant screening results.\n* Women of child-bearing potential (WOCBP) AND men with partners who are WOCBP must agree that they and/or their partner will use two reliable forms of contraception as per study requirements\n* WOCBP must have a negative serum β-hCG pregnancy test at the Screening and Baseline visit.\n* Voluntarily consent to participate in the trial\n\nExclusion Criteria:\n\n* Unwilling or unable to provide written informed consent\n* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, coagulation, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease\n* Evidence of organ dysfunction or any clinically significant deviation from normal in vital signs, physical examination, clinical laboratory determinations or ECG\n* Any major surgery within 3 months of Screening\n* Positive urine drug/alcohol testing at Screening or Baseline visit\n* Use of tobacco and/or nicotine-containing products within 3 months prior to the start of dosing of the trial\n* Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV Ab) at Screening\n* History or presence of alcoholism or drug abuse as defined in DSM V, Diagnostic Criteria for Drug and Alcohol Abuse\n* History of hypersensitivity or idiosyncratic reaction to drugs from multiple drug classes\n* Any previous gastrointestinal surgery or recent (within 3 months) history of gastrointestinal disease that could impact the absorption of the study drug\n* Blood donation or significant blood loss within 8 weeks prior to Day 1 of the trial\n* Plasma donation within 7 days prior to Day 1 of the trial\n* Blood transfusion within 4 weeks of Screening\n* Positive serum pregnancy test (WOCBP) at the Screening or Baseline visit\n* Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical disease (e.g., infectious disease) must not be enrolled into this study\n* Any other medical, psychiatric, and/or social reason as determined by the Investigator'}, 'identificationModule': {'nctId': 'NCT03724292', 'briefTitle': 'An Ascending Multiple Dose Study With VTP-43742 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vitae Pharmaceuticals, Inc.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Ascending Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VTP-43742 in Healthy Volunteers and Proof-of-Concept in Psoriatic Patients', 'orgStudyIdInfo': {'id': 'VTP-43742-002-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Dose-matched placebo administered as oral capsule(s) once daily', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'VTP-43742 Dose 1', 'description': 'VTP-43742 administered as oral capsule(s) once daily', 'interventionNames': ['Drug: VTP-43742']}, {'type': 'EXPERIMENTAL', 'label': 'VTP-43742 Dose 2', 'description': 'VTP-43742 administered as oral capsule(s) once daily', 'interventionNames': ['Drug: VTP-43742']}, {'type': 'EXPERIMENTAL', 'label': 'VTP-43742 Dose 3', 'description': 'VTP-43742 administered as oral capsule(s) once daily', 'interventionNames': ['Drug: VTP-43742']}, {'type': 'EXPERIMENTAL', 'label': 'VTP-43742 Dose 4', 'description': 'VTP-43742 administered as oral capsule(s) once daily', 'interventionNames': ['Drug: VTP-43742']}, {'type': 'EXPERIMENTAL', 'label': 'VTP-43742 Dose 5', 'description': 'VTP-43742 administered as oral capsule(s) once daily', 'interventionNames': ['Drug: VTP-43742']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Dose-matched placebo administered as oral capsule(s) once daily', 'armGroupLabels': ['Placebo']}, {'name': 'VTP-43742', 'type': 'DRUG', 'description': 'VTP-43742 administered as oral capsule(s) once daily', 'armGroupLabels': ['VTP-43742 Dose 1', 'VTP-43742 Dose 2', 'VTP-43742 Dose 3', 'VTP-43742 Dose 4', 'VTP-43742 Dose 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07410', 'city': 'Fair Lawn', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Healthy Volunteer Site 1', 'geoPoint': {'lat': 40.94038, 'lon': -74.13181}}], 'overallOfficials': [{'name': 'Richard Gregg, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vitae Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vitae Pharmaceuticals Inc., an Allergan affiliate', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}