Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-02-25 @ 11:01 PM
Study NCT ID:
NCT02214433
Status:
COMPLETED
Last Update Posted:
2015-02-25
First Post:
2014-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multiple Dose Study of Debio 1450 [Intravenous (IV) and Oral] in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002214', 'term': 'Capsules'}, {'id': 'C000657127', 'term': 'afabicin'}, {'id': 'D000077402', 'term': 'Pantoprazole'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-24', 'studyFirstSubmitDate': '2014-08-08', 'studyFirstSubmitQcDate': '2014-08-08', 'lastUpdatePostDateStruct': {'date': '2015-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with clinically significant change from baseline in safety parameters', 'timeFrame': 'within 10 days post-dose', 'description': 'Categories: vital signs, 12-lead electrocardiogram (ECG), clinical laboratory parameters, adverse events, pulmonary function, physical examination, concomitant medication'}, {'measure': 'Maximum observed plasma concentration (Cmax) of Debio 1450 (prodrug) and Debio 1452 (active moiety)', 'timeFrame': 'within 60 hours post-dose, depending on the assessment schedule for the cohort', 'description': 'Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution'}, {'measure': 'Time of maximum observed plasma concentration (tmax) of Debio 1450 and Debio 1452', 'timeFrame': 'within 60 hours post-dose, depending on the assessment schedule for the cohort', 'description': 'Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution'}, {'measure': 'Area under the plasma concentration-time curve (AUC) of Debio 1450 and Debio 1452', 'timeFrame': 'within 60 hours post-dose, depending on the assessment schedule for the cohort', 'description': 'Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution'}, {'measure': 'Percentage of AUC(0-o) that is due to extrapolation beyond the last quantifiable concentration measurement (%AUCex) of Debio 1450 and Debio 1452', 'timeFrame': 'within 60 hours post-dose, depending on the assessment schedule for the cohort', 'description': 'Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution'}, {'measure': 'Elimination half-life (t1/2) of Debio 1450 and Debio 1452', 'timeFrame': 'within 60 hours post-dose, depending on the assessment schedule for the cohort', 'description': 'Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution'}, {'measure': 'Terminal elimination rate constant (Az) of Debio 1450 and Debio 1452', 'timeFrame': 'within 60 hours post-dose, depending on the assessment schedule for the cohort', 'description': 'Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution'}, {'measure': 'Mean residence time (MRT) of Debio 1450 and Debio 1452', 'timeFrame': 'within 60 hours post-dose, depending on the assessment schedule for the cohort', 'description': 'Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution'}, {'measure': 'Apparent clearance following oral administration (CL/F) of Debio 1450 and Debio 1452', 'timeFrame': 'within 60 hours post-dose, depending on the assessment schedule for the cohort', 'description': 'Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution'}, {'measure': 'Apparent volume of distribution of Debio 1450 and Debio 1452 during terminal phase (Vz/F)', 'timeFrame': 'within 60 hours post-dose, depending on the assessment schedule for the cohort', 'description': 'Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution'}, {'measure': 'Cumulative amount of unchanged Debio 1450 and Debio 1452 excreted in urine (Ae)', 'timeFrame': 'within 60 hours post-dose, depending on the assessment schedule for the cohort', 'description': 'Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution'}, {'measure': 'Percentage of cumulative amount of unchanged Debio 1450 and Debio 1452 excreted in urine (Ae%)', 'timeFrame': 'within 60 hours post-dose, depending on the assessment schedule for the cohort', 'description': 'Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution'}, {'measure': 'Renal clearance following oral administration', 'timeFrame': 'within 60 hours post-dose, depending on the assessment schedule for the cohort', 'description': 'Categories: Placebo Tablet or Capsule, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Antibiotic', 'Antibiotic Resistant Bacterial Infection'], 'conditions': ['Bacterial Infections']}, 'descriptionModule': {'briefSummary': 'Debio 1450-103 is a trial to study the pharmacokinetics (PK) of an experimental drug called Debio 1450 in healthy adult volunteers. Originally, Part A was registered separately (in NCT02214355). The registrations have been revised so all parts of this single trial (Parts A-C) are now included in this single registration (NCT02214433).\n\nThe primary purpose of each part is provided below:\n\n* 10 volunteers participate in PART A to assess the PK of a single oral dose of Debio 1450 (tablet formulation) under varying gastric conditions\n* 40 volunteers participate in PART B to assess the safety, tolerability and PK of multiple ascending doses of Debio 1450, administered sequentially IV and orally, once or twice daily.\n* An additional 10 volunteers participate in PART C which is designed to assess the absolute bioavailability of various formulations of Debio 1450 under varying gastric conditions\n\nThe dose administered during Part A is based on the safety, tolerability and PK data from study Debio 1450-102 \\[NCT02162199\\], a single ascending dose (SAD) study, in which single oral doses up to 800 mg/day are being investigated. Doses are adjusted during Parts B and C based on the available safety and PK data from preceding cohorts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meets protocol-specified criteria for qualification and/or contraception\n* Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications\n* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures\n\nExclusion Criteria:\n\n* Has a history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters\n* Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:\n\n 1. the safety or well-being of the participant or study staff\n 2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)\n 3. the analysis of results"}, 'identificationModule': {'nctId': 'NCT02214433', 'briefTitle': 'A Multiple Dose Study of Debio 1450 [Intravenous (IV) and Oral] in Healthy Volunteers', 'nctIdAliases': ['NCT02214355'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Debiopharm International SA'}, 'officialTitle': 'A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Debio 1450 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'Debio 1450-103'}, 'secondaryIdInfos': [{'id': '217595', 'type': 'OTHER', 'domain': 'CRO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A Period 1 Debio 1450 IV Solution', 'description': 'Part A Debio 1450 IV solution infused over two hours on Day 1 after fasting', 'interventionNames': ['Drug: Debio 1450 IV Solution']}, {'type': 'EXPERIMENTAL', 'label': 'Part A Period 2 Debio 1450 Tablet', 'description': 'Debio 1450 Tablet oral dosing once on Day 5, after fasting', 'interventionNames': ['Drug: Debio 1450 Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Part A Period 3 Debio 1450 Tablet', 'description': 'Debio 1450 Tablet oral dosing once on Day 9, 30 minutes after a high calorie, high fat breakfast, after fasting', 'interventionNames': ['Drug: Debio 1450 Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Part A Period 4 Debio 1450 Tablet', 'description': 'After preparation with Pantoprazole, Pantoprazole taken with Debio 1450 Tablet oral dosing once on Day 14, after fasting', 'interventionNames': ['Drug: Debio 1450 Tablet', 'Drug: Pantoprazole']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part B Placebo All Cohorts', 'description': 'Placebo IV solution on days 1-5 and then Placebo Tablet or Capsule on Days 6-10, according to the cohort dosing schedule', 'interventionNames': ['Drug: Placebo IV Solution', 'Drug: Placebo Tablet or Capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Debio 1450 Cohort 1', 'description': 'Debio 1450 IV solution, once daily on days 1-5, then Debio 1450 Tablet, once daily on days 6-10', 'interventionNames': ['Drug: Debio 1450 IV Solution', 'Drug: Debio 1450 Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Debio 1450 Cohort 2a', 'description': 'Debio 1450 IV solution, once daily on day 1', 'interventionNames': ['Drug: Debio 1450 IV Solution']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Debio 1450 Cohort 3', 'description': 'Debio 1450 IV solution, twice daily on days 1-5, then Debio 1450 Capsule, twice daily on days 6-10', 'interventionNames': ['Drug: Debio 1450 IV Solution', 'Drug: Debio 1450 Capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Debio 1450 Cohort 4', 'description': 'Debio 1450 IV solution, twice daily on days 1-5, then Debio 1450 Capsule, twice daily on days 6-10', 'interventionNames': ['Drug: Debio 1450 IV Solution', 'Drug: Debio 1450 Capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Debio 1450 Cohort 2b', 'description': 'Debio 1450 IV solution, once daily on days 1-5, then Debio 1450 Capsule, once daily on days 6-10', 'interventionNames': ['Drug: Debio 1450 IV Solution', 'Drug: Debio 1450 Capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Part C Debio 1450', 'description': 'Debio 1450 (IV formulation in Period 1, capsule formulation in Periods 2, 4 and 5 (with Pantoprazole), and Debio 1450 oral solution in Period 3).', 'interventionNames': ['Drug: Debio 1450 IV Solution', 'Drug: Debio 1450 Capsule', 'Drug: Debio 1450 Oral Solution', 'Drug: Pantoprazole']}], 'interventions': [{'name': 'Placebo IV Solution', 'type': 'DRUG', 'description': 'A sterile IV solution of 5% dextrose in water', 'armGroupLabels': ['Part B Placebo All Cohorts']}, {'name': 'Debio 1450 IV Solution', 'type': 'DRUG', 'description': 'A white to off-white powder (40 mg Debio 1450 per vial) to be reconstituted and formulated in a sterile IV solution of 5% dextrose in water', 'armGroupLabels': ['Part A Period 1 Debio 1450 IV Solution', 'Part B Debio 1450 Cohort 1', 'Part B Debio 1450 Cohort 2a', 'Part B Debio 1450 Cohort 2b', 'Part B Debio 1450 Cohort 3', 'Part B Debio 1450 Cohort 4', 'Part C Debio 1450']}, {'name': 'Placebo Tablet or Capsule', 'type': 'DRUG', 'description': 'Placebo tablet or capsule, matching Debio 1450 coated tablet or capsule', 'armGroupLabels': ['Part B Placebo All Cohorts']}, {'name': 'Debio 1450 Tablet', 'type': 'DRUG', 'description': 'Debio 1450 40 mg coated tablets', 'armGroupLabels': ['Part A Period 2 Debio 1450 Tablet', 'Part A Period 3 Debio 1450 Tablet', 'Part A Period 4 Debio 1450 Tablet', 'Part B Debio 1450 Cohort 1']}, {'name': 'Debio 1450 Capsule', 'type': 'DRUG', 'description': 'Debio 1450 40 mg capsules', 'armGroupLabels': ['Part B Debio 1450 Cohort 2b', 'Part B Debio 1450 Cohort 3', 'Part B Debio 1450 Cohort 4', 'Part C Debio 1450']}, {'name': 'Debio 1450 Oral Solution', 'type': 'DRUG', 'description': 'Lyophilized Debio 1450 (40 mg per vial) reconstituted in 5% dextrose in water', 'armGroupLabels': ['Part C Debio 1450']}, {'name': 'Pantoprazole', 'type': 'DRUG', 'description': 'Pantoprazole 40 mg orally', 'armGroupLabels': ['Part A Period 4 Debio 1450 Tablet', 'Part C Debio 1450']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21225', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Early Phase Clinical Unit', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Frederick Wittke, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Debiopharm International SA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Debiopharm International SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}