- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03080987
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Japanese Participants
October 12, 2018 updated by: Janssen Research & Development, LLC
A 2-Part Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Japanese Subjects
The primary purpose of this study is to assess the safety and tolerability of JNJ-64179375 in Part 1 and 2.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Fukuoka, Japan, 812-0025
- Souseikai Hakata Clinic
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London, United Kingdom, NW10 7EW
- Hammersmith Medicines Research Ltd
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Must have been born in Japan of Japanese parents and maternal and paternal Japanese grandparents
- Body mass index (weight kg/m^2) between 18 and 27 kilogram per square meter (kg/m^2) (inclusive), and body weight greater than 50 kg but less than 100 kg
- Generally in good health on the basis of physical examinations, medical history, vital signs, laboratory tests, electrocardiograms (ECGs) and cardiac telemetry performed at Screening and/or prior to administration of the initial dose of study drug
- 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
Exclusion Criteria:
- 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 (including any personal or family history of abnormal bleeding as assessed by a detailed bleeding history or blood dyscrasias), or with an underlying coagulopathy that may lead to a clinically relevant bleeding risk, autoimmune disease, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
- 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
- Clinically significant abnormal physical exam at Screening or Day -1
- Clinically significant abnormal vital signs at Screening, Day -1, or Day 1 (predose) as determined by the investigator or appropriate designee
- Clinically significant abnormal cardiac telemetry, or ECG at Screening, Day -1, or Day 1 (predose) as determined by the investigator or appropriate designee
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part 1: Cohort 1 (0.3 mg/kg of JNJ-64179375 or Placebo)
Participants will receive a single 0.3 milligram per kilogram (mg/kg) intravenous (IV) dose of JNJ-64179375 or matching Placebo on Day 1.
|
JNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenous (IV) infusion on Day 1.
Matching placebo on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).
|
Experimental: Part 1: Cohort 2 (1.0 mg/kg of JNJ-64179375 or Placebo)
Participants will receive a single 1.0 mg/kg IV dose of JNJ-64179375 or matching Placebo on Day 1.
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Matching placebo on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).
JNJ-64179375 1.0 mg/kg on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).
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Experimental: Part 1: Cohort 3 (2.5 mg/kg of JNJ-64179375 or Placebo)
Participants will receive a single 2.5 mg/kg IV dose of JNJ-64179375 or matching Placebo on Day 1.
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Matching placebo on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).
JNJ-64179375 2.5 mg/kg IV infusion on Day 1.
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Experimental: Part 1: Optional Cohort 1 (JNJ-64179375 or Placebo)
Participants will receive a single IV dose of JNJ-64179375 (dose to be determined) or matching Placebo on Day 1.
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Matching placebo on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).
JNJ-64179375 IV infusion (Dose to be determined).
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Experimental: Part 1: Optional Cohort 2 (JNJ-64179375 or Placebo)
Participants will receive a single IV dose of JNJ-64179375 (dose to be determined) or matching Placebo on Day 1.
|
Matching placebo on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).
JNJ-64179375 IV infusion (Dose to be determined).
|
Experimental: Part 2: SC Cohort (1.0 mg/kg of JNJ-64179375 or Placebo)
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.
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Matching placebo on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).
JNJ-64179375 1.0 mg/kg on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time Frame: Up to Day 113
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An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
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Up to Day 113
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Part 2: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time Frame: Up to Day 113
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An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
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Up to Day 113
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part 1 and 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-64179375
Time Frame: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
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Cmax is the maximum observed plasma concentration.
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Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
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Part 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of JNJ-64179375
Time Frame: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
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The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
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Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
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Part 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-64179375
Time Frame: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
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The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time.
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Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
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Part 1: Total Systemic Clearance (CL) of JNJ-64179375
Time Frame: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
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CL is defined as total systemic clearance after intravenous administration of JNJ-64179375.
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Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
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Part 1: Apparent Volume of Distribution at Terminal Phase After Intravenous Administration (Vz) of JNJ-64179375
Time Frame: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
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Vz is defined as the Apparent volume of distribution at terminal phase after intravenous administration.
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Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
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Part 1 and 2: Terminal Half-Life (t1/2) of JNJ-64179375
Time Frame: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
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Half-life is the time measured for the plasma concentration of drug to decrease by one half.
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Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
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Part 2: Total Systemic Clearance Over Bioavailability After Subcutaneous (SC) Administration (CL/F) of JNJ-64179375 post-dose
Time Frame: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
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CL/F is defined as total systemic clearance over bioavailability after SC administration.
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Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
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Part 2: Apparent Volume of Distribution at Terminal Phase Over Bioavailability After Subcutaneous Administration (Vz/F) of JNJ-64179375
Time Frame: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
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(Vz/F) is defined as Apparent Volume of distribution at terminal phase over bioavailability after SC administration of JNJ-64179375.
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Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
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Part 2: Absolute Bioavailability (F) After Subcutaneous Administration of JNJ-64179375
Time Frame: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
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F is defined as absolute bioavailability after SC administration of JNJ-64179375.
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Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
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Part 1 and 2: Immunogenicity of JNJ-64179375
Time Frame: Predose, Day 7, 14, 29, 57, 85 and 113 post-dose
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Plasma samples will be collected and screened for antibodies binding to JNJ-64179375 and the titer of confirmed positive samples will be reported.
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Predose, Day 7, 14, 29, 57, 85 and 113 post-dose
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Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Thrombin Time (TT)
Time Frame: Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
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The pharmacodynamic effect of JNJ-64179375 on coagulation parameters will be assessed by measuring the change in thrombin time (TT).
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Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
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Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Prothrombin Time (PT)
Time Frame: Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
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The pharmacodynamic effect of JNJ-64179375 on coagulation parameters will be assessed by measuring the change in prothrombin time (PT).
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Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
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Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Activated Partial Thromboplastin time (aPTT)
Time Frame: Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
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The pharmacodynamic effect of JNJ-64179375 on coagulation parameters will be assessed by measuring the change in activated partial thromboplastin time (aPTT).
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Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
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Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Ecarin Clotting time (ECT)
Time Frame: Predose, Day 1, 2, 4, and 14 post-dose
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The pharmacodynamic effect of JNJ-64179375 on coagulation parameters will be assessed by measuring the change in Ecarin Clotting time (ECT).
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Predose, Day 1, 2, 4, and 14 post-dose
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Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 on Platelet Function
Time Frame: Predose, Days 1 and 14 post-dose
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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.
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Predose, Days 1 and 14 post-dose
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Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Thrombin Generation Assay (TGA)
Time Frame: Predose, Day 1 and 14 post-dose
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The TGA is based on the premise that measurements of thrombin generation are indicative of the overall coagulating capacity of the individual.
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Predose, Day 1 and 14 post-dose
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Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by D-dimer
Time Frame: Predose, Day 1 and 14 post-dose
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The D-dimer assay is an enzyme immunoassay procedure for the quantitative determination of D-dimer.
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Predose, Day 1 and 14 post-dose
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Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in International Normalized Ratio (INR)
Time Frame: Predose, Day 1, 2,4, 7, 14, 29, 57 and 113 post-dose
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The pharmacodynamic effect of JNJ-64179375 on coagulation parameters will be assessed by measuring the change in international normalized ratio (INR).
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Predose, Day 1, 2,4, 7, 14, 29, 57 and 113 post-dose
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Part 2: Time to Maximum Observed Plasma Concentration (Tmax) After Subcutaneous Administration of JNJ-64179375
Time Frame: Predose, Day 1, 2,4, 7, 10, 14, 22, 29,43, 57, 85 and 113 post-dose
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The Tmax is defined as actual sampling time to reach maximum observed plasma concentration.
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Predose, Day 1, 2,4, 7, 10, 14, 22, 29,43, 57, 85 and 113 post-dose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 27, 2017
Primary Completion (Actual)
June 25, 2018
Study Completion (Actual)
June 25, 2018
Study Registration Dates
First Submitted
March 10, 2017
First Submitted That Met QC Criteria
March 10, 2017
First Posted (Actual)
March 15, 2017
Study Record Updates
Last Update Posted (Actual)
October 15, 2018
Last Update Submitted That Met QC Criteria
October 12, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- CR108306
- 2016-004785-25 (EudraCT Number)
- 64179375EDI1002 (Other Identifier: Janssen Research & Development, LLC)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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