Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2026-01-22 @ 8:03 AM
Study NCT ID:
NCT02949206
Status:
COMPLETED
Last Update Posted:
2017-09-25
First Post:
2016-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Male 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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-22', 'studyFirstSubmitDate': '2016-10-27', 'studyFirstSubmitQcDate': '2016-10-27', 'lastUpdatePostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability', 'timeFrame': 'Up to Day 113'}, {'measure': 'Part 3: Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability', 'timeFrame': 'Up to Day 113'}, {'measure': 'Part 2: Change From Baseline in Potential for Reversibility of the JNJ-64179375 Induced Pharmacodynamic Effects on Coagulation Parameters', 'timeFrame': 'Baseline and Day 1', 'description': 'Change in Potential for Reversibility of the JNJ-64179375 will be assessed by assessing the change in thrombin time as coagulation parameter.'}, {'measure': 'Part 2: Change From Baseline in Potential for Reversibility of the JNJ-64179375 Induced Pharmacodynamic Effects on Platelet Function', 'timeFrame': 'Baseline and Day 1', 'description': 'Platelet function will be assessed by measuring platelet activation and aggregation in response to thrombin and other agonists and with the platelet function analyzer (PFA)100.'}], 'secondaryOutcomes': [{'measure': 'Part 1 and 3: Maximum Observed Plasma Concentration (Cmax) of JNJ-64179375', 'timeFrame': 'Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113', 'description': 'Cmax is defined as maximum observed plasma concentration of JNJ-64179375.'}, {'measure': 'Part 1 and 3: Area Under the Plasma Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of JNJ-64179375', 'timeFrame': 'Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113', 'description': 'The (AUC \\[0-last\\]) is defined as Area under the plasma concentration versus time curve from time 0 to the time corresponding to the last quantifiable serum concentration of JNJ-64179375.'}, {'measure': 'Part 1 and 3: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-64179375', 'timeFrame': 'Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113', 'description': 'The (AUC \\[0-infinity\\]) is defined as Area under the plasma concentration versus time curve from time 0 to infinity with extrapolation of the terminal phase.'}, {'measure': 'Part 1 and 3: Terminal Half-Life (t1/2) of JNJ-64179375', 'timeFrame': 'Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113', 'description': 'Half-life (t\\[1/2\\]) is associated with the terminal slope (lambda \\[z\\]) of the semi-logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).'}, {'measure': 'Part 1: Total Systemic Clearance (CL) of JNJ-64179375', 'timeFrame': 'Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113', 'description': 'CL is defined as total systemic clearance after intravenous administration of JNJ-64179375.'}, {'measure': 'Part 1: Apparent Volume of Distribution at Terminal Phase After Intravenous Administration (Vz) of JNJ-64179375', 'timeFrame': 'Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113', 'description': 'Vz is defined as the Apparent volume of distribution at terminal phase after intravenous administration.'}, {'measure': 'Part 3: Time to Reach Maximum Observed Concentration (Tmax) of JNJ-64179375', 'timeFrame': 'Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113', 'description': 'Tmax is defined as time to the maximum observed plasma concentration of JNJ-64179375.'}, {'measure': 'Part 3: Total Systemic Clearance Over Bioavailability After Subcutaneous (SC) Administration (CL/F) of JNJ-64179375', 'timeFrame': 'Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113', 'description': 'CL/F is defined as total systemic clearance over bioavailability after SC administration.'}, {'measure': 'Part 3: Apparent Volume of Distribution at Terminal Phase Over Bioavailability After Subcutaneous Administration (Vz/F) of JNJ-64179375', 'timeFrame': 'Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113', 'description': '(Vz/F) is defined as Apparent Volume of distribution at terminal phase over bioavailability after SC administration of JNJ-64179375.'}, {'measure': 'Part 3: Absolute Bioavailability (F) After Subcutaneous Administration of JNJ-64179375', 'timeFrame': 'Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113', 'description': 'F is defined as absolute bioavailability after SC administration of JNJ-64179375.'}, {'measure': 'Part 1 and 3: Immunogenicity of JNJ-64179375', 'timeFrame': 'Predose, Day 7, 14, 29, 57, 85 and 113', 'description': 'Plasma samples will be collected and screened for antibodies binding to JNJ-64179375 and the titer of confirmed positive samples will be reported.'}, {'measure': 'Part 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-64179375 in presence of 4-factor prothrombin complex concentrate (PCC)', 'timeFrame': 'Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113', 'description': 'Cmax is defined as maximum observed plasma concentration of JNJ-64179375.'}, {'measure': 'Part 2: Area Under the Plasma ConcentrationTime Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC [0-last]) of JNJ-64179375 in the presence of 4-factor PCC', 'timeFrame': 'Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113', 'description': 'The (AUC \\[0-last\\]) is defined as Area under the plasma concentration versus time curve from time 0 to the time corresponding to the last quantifiable serum concentration of JNJ-64179375'}, {'measure': 'Part 2: Area Under the Plasma ConcentrationTime Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-64179375 in the presence of 4-factor PCC', 'timeFrame': 'Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113', 'description': 'The (AUC \\[0-infinity\\]) is defined as Area under the plasma concentration versus time curve from time 0 to infinity with extrapolation of the terminal phase.'}, {'measure': 'Part 2: Terminal Half Life [t(1/2)] of JNJ-64179375 in the presence of 4-factor PCC', 'timeFrame': 'Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113', 'description': 'Half life \\[t(1/2)\\] is associated with the terminal slope (lambda \\[z\\]) of the semilogarithmic drug concentration time curve, calculated as 0.693/lambda(z).'}, {'measure': 'Part 2: Total Systemic Clearance (CL) of JNJ-64179375 in the presence of 4-factor PCC', 'timeFrame': 'Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113', 'description': 'CL is defined as total systemic clearance after intravenous administration of JNJ-64179375.'}, {'measure': 'Part 2: Apparent Volume of Distribution at Terminal Phase After Intravenous Administration (Vz) of JNJ-64179375 in the presence of 4-factor PCC', 'timeFrame': 'Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113', 'description': 'Vz is defined as the Apparent volume of distribution at terminal phase after intravenous administration.'}, {'measure': 'Part 2: Immunogenicity of JNJ-64179375 in the presence of 4-factor PCC', 'timeFrame': 'Predose, Day 7, 14, 29, 57, 85 and 113', 'description': 'Plasma samples will be collected and screened for antibodies binding to JNJ-64179375 and the titer of confirmed positive samples will be reported.'}, {'measure': 'Part 2: Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability', 'timeFrame': 'Baseline to End of treatment (Day 113)'}, {'measure': 'Part 1 and 3: Pharmacodynamic Effect of JNJ-64179375 on Platelet Function', 'timeFrame': 'Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113', 'description': 'Platelet function will be assessed by measuring platelet activation and aggregation in response to thrombin and other agonists and with the platelet function analyzer (PFA)-100.'}, {'measure': 'Part 1 and 3: Pharmacodynamic Effect of JNJ-64179375 on Coagulation Parameters', 'timeFrame': 'Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113', 'description': 'The pharmacodynamic effect of JNJ-64179375 on coagulation parameters will be assessed by measuring the change in thrombin time.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and tolerability of JNJ-64179375 in Part 1 (Intravenous dose) and Part 3 (Subcutaneous dose) and potential for reversibility of JNJ-64179375 induced Pharmacodynamic effects on coagulation parameters and platelet function (Part 2) in healthy male participants.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index \\[weight kilogram per meter square (kg/m\\^2)\\] between 18 and 30 kg/m\\^2 (inclusive), and body weight greater than 50 kilogram (kg) but less than 100 kg\n* Generally in good health on the basis of physical examination, medical history, vital signs, laboratory tests, and electrocardiogram (ECG) performed at screening and/or prior to administration of the initial dose of study drug\n* Must sign an informed consent form (ICF) indicating that he understands the purpose of, and procedures required for, the study and is willing to participate in the study\n* contraceptive use by men should be consistent with local regulations regarding the use of contraceptive methods for subject participating in clinical studies\n* willing and able to adhere to the study visit schedule and other requirements, prohibitions, and restrictions specified in this protocol through the Day 113 visit\n\nExclusion Criteria:\n\n* Acute illness, including an upper respiratory infection (with or without fever), within 7 days prior to study drug administration or have had a major illness or hospitalization within 1 month prior to study drug administration\n* Clinically significant abnormal values for coagulation, hematology, clinical chemistry or urinalysis at screening or on Day -1 (at admission to the clinical research unit) as determined by the investigator or appropriate designee\n* Have smoked tobacco or nicotine-related products within 6 months prior to dosing or does not agree to refrain through Day 113\n* Donated blood or blood products or had substantial loss of blood \\[more than 500 milliliter (mL)\\] within 3 months before the first administration of study drug or intends to donate or donates blood or blood products during the study until 30 days after completion\n* History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, bleeding or thrombotic disorders'}, 'identificationModule': {'nctId': 'NCT02949206', 'briefTitle': 'A Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'A 3-Part First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'CR108238'}, 'secondaryIdInfos': [{'id': '64179375EDI1001', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}, {'id': '2016-003006-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: Cohort 1 (0.03 mg/kg of JNJ-64179375 or Placebo)', 'description': 'Participants in a ratio of 3:1 will receive a single 0.03 milligram per kilogram (mg/kg) intravenous (IV) dose of JNJ-64179375 or matching placebo on Day 1.', 'interventionNames': ['Drug: JNJ-64179375', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Cohort 2 (0.1 mg/kg of JNJ-64179375 or Placebo)', 'description': 'Participants in a ratio of 3:1 will receive a single 0.1 mg/kg IV dose of JNJ-64179375 or matching placebo on Day 1.', 'interventionNames': ['Drug: JNJ-64179375', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Cohort 3 (0.3 mg/kg of JNJ-64179375 or Placebo)', 'description': 'Participants in a ratio of 3:1 will receive a single 0.3 mg/kg IV dose of JNJ-64179375 or matching placebo on Day 1.', 'interventionNames': ['Drug: JNJ-64179375', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Cohort 4 (1.0 mg/kg of JNJ-64179375 or Placebo)', 'description': 'Participants in a ratio of 3:1 will receive a single 1.0 mg/kg IV dose of JNJ-64179375 or matching placebo on Day 1.', 'interventionNames': ['Drug: JNJ-64179375', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Cohort 5 (2.5 mg/kg of JNJ-64179375 or Placebo)', 'description': 'Participants in a ratio of 3:1 will receive a single 2.5 mg/kg IV dose of JNJ-64179375 or matching placebo on Day 1.', 'interventionNames': ['Drug: JNJ-64179375', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Cohort 6 (5.0 mg/kg of JNJ-64179375 or Placebo)', 'description': 'Participants in a ratio of 3:1 will receive a single 5.0 mg/kg IV dose of JNJ-64179375 or matching placebo on Day 1.', 'interventionNames': ['Drug: JNJ-64179375', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Cohort 7 (Escalation Dose of JNJ-64179375 or Placebo)', 'description': 'Dose escalation will proceed until the toxicology study exposure limits or a highest tolerable dose will be reached.', 'interventionNames': ['Drug: JNJ-64179375', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Cohort 8 (Escalation Dose of JNJ-64179375 or Placebo)', 'description': 'Dose escalation will proceed until the toxicology study exposure limits or a highest tolerable dose will be reached.', 'interventionNames': ['Drug: JNJ-64179375', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Reversal Cohort :(50 IU/kg of 4-factor PCC)', 'description': 'Participants will receive a 2.5 mg/kg of JNJ-64179375 or highest tolerable dose if lower than 2.5 mg/kg followed by administration of a single IV 50 International Unit per kilogram (IU/Kg) dose of a 4 factor prothrombin complex concentrate (PCC) or matching placebo on Day 1.', 'interventionNames': ['Drug: JNJ-64179375', 'Drug: Placebo', 'Drug: 4 Factor Prothrombin Complex Concentrate (PCC)']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3: Subcutaneous Cohort (1.0 mg/kg of JNJ-64179375)', 'description': 'Participants will receive a Single Subcutaneous (SC) dose of 1.0 mg.kg or highest tolerable dose if less than 1.0 mg/kg of JNJ-64179375 or matching placebo on Day 1.', 'interventionNames': ['Drug: JNJ-64179375', 'Drug: Placebo']}], 'interventions': [{'name': 'JNJ-64179375', 'type': 'DRUG', 'description': 'During part 1, participants will receive a single ascending Intravenous dose of JNJ-64179375 ranging from (0.03 mg/kg to 5.0 mg/kg). In Part 2, participants will receive a 2.5 mg/kg or highest tolerable dose if lower than 2.5 mg/kg of JNJ-64179375. In Part 3, participants will receive a Single Subcutaneous (SC) dose of 1.0 mg/kg or highest tolerable dose if less than 1.0 mg/kg of JNJ-64179375.', 'armGroupLabels': ['Part 1: Cohort 1 (0.03 mg/kg of JNJ-64179375 or Placebo)', 'Part 1: Cohort 2 (0.1 mg/kg of JNJ-64179375 or Placebo)', 'Part 1: Cohort 3 (0.3 mg/kg of JNJ-64179375 or Placebo)', 'Part 1: Cohort 4 (1.0 mg/kg of JNJ-64179375 or Placebo)', 'Part 1: Cohort 5 (2.5 mg/kg of JNJ-64179375 or Placebo)', 'Part 1: Cohort 6 (5.0 mg/kg of JNJ-64179375 or Placebo)', 'Part 1: Cohort 7 (Escalation Dose of JNJ-64179375 or Placebo)', 'Part 1: Cohort 8 (Escalation Dose of JNJ-64179375 or Placebo)', 'Part 2: Reversal Cohort :(50 IU/kg of 4-factor PCC)', 'Part 3: Subcutaneous Cohort (1.0 mg/kg of JNJ-64179375)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will randomly receive matching placebo in all 3 Parts on day 1 administered via IV Route (for Part 1 and 2) and SC route (for Part 3).', 'armGroupLabels': ['Part 1: Cohort 1 (0.03 mg/kg of JNJ-64179375 or Placebo)', 'Part 1: Cohort 2 (0.1 mg/kg of JNJ-64179375 or Placebo)', 'Part 1: Cohort 3 (0.3 mg/kg of JNJ-64179375 or Placebo)', 'Part 1: Cohort 4 (1.0 mg/kg of JNJ-64179375 or Placebo)', 'Part 1: Cohort 5 (2.5 mg/kg of JNJ-64179375 or Placebo)', 'Part 1: Cohort 6 (5.0 mg/kg of JNJ-64179375 or Placebo)', 'Part 1: Cohort 7 (Escalation Dose of JNJ-64179375 or Placebo)', 'Part 1: Cohort 8 (Escalation Dose of JNJ-64179375 or Placebo)', 'Part 2: Reversal Cohort :(50 IU/kg of 4-factor PCC)', 'Part 3: Subcutaneous Cohort (1.0 mg/kg of JNJ-64179375)']}, {'name': '4 Factor Prothrombin Complex Concentrate (PCC)', 'type': 'DRUG', 'description': 'Following a single dose of JNJ-64179375, participants will receive a single IV dose of 4 factor-PCC.', 'armGroupLabels': ['Part 2: Reversal Cohort :(50 IU/kg of 4-factor PCC)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Merksem', 'country': 'Belgium', 'geoPoint': {'lat': 51.24623, 'lon': 4.44903}}], 'overallOfficials': [{'name': 'Janssen Research & Development, LLC Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Research & Development, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}