Clinical trial NCT03080987: A Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Japanese Participants
Official title: A 2-Part Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2017-03-15
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to assess the safety and tolerability of JNJ-64179375 in Part 1 and 2.


Eligibility criteria: 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

Primary outcomes:
measure: Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to Day 113
measure: Part 2: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to Day 113
Secondary outcomes:
measure: Part 1 and 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-64179375
timeFrame: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
measure: Part 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of JNJ-64179375
timeFrame: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
measure: Part 1 and 2: 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 post-dose
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 post-dose
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 post-dose
measure: Part 1 and 2: Terminal Half-Life (t1/2) of JNJ-64179375
timeFrame: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
measure: Part 2: Total Systemic Clearance Over Bioavailability After Subcutaneous (SC) Administration (CL/F) of JNJ-64179375 post-dose
timeFrame: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
measure: Part 2: 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 post-dose
measure: Part 2: 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 post-dose
measure: Part 1 and 2: Immunogenicity of JNJ-64179375
timeFrame: Predose, Day 7, 14, 29, 57, 85 and 113 post-dose
measure: Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Thrombin Time (TT)
timeFrame: Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
measure: Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Prothrombin Time (PT)
timeFrame: Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
measure: Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Activated Partial Thromboplastin time (aPTT)
timeFrame: Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
measure: Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Ecarin Clotting time (ECT)
timeFrame: Predose, Day 1, 2, 4, and 14 post-dose
measure: Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 on Platelet Function
timeFrame: Predose, Days 1 and 14 post-dose
measure: Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Thrombin Generation Assay (TGA)
timeFrame: Predose, Day 1 and 14 post-dose
measure: Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by D-dimer
timeFrame: Predose, Day 1 and 14 post-dose
measure: Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in International Normalized Ratio (INR)
timeFrame: Predose, Day 1, 2,4, 7, 14, 29, 57 and 113 post-dose
measure: Part 2: Time to Maximum Observed Plasma Concentration (Tmax) After Subcutaneous Administration of JNJ-64179375
timeFrame: Predose, Day 1, 2,4, 7, 10, 14, 22, 29,43, 57, 85 and 113 post-dose
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Souseikai Hakata Clinic
city: London
country: United Kingdom
facility: Hammersmith Medicines Research Ltd
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: