Clinical trial NCT02949206: A Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Male Subjects
Official title: A 3-Part First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2016-10-31
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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
* 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
* 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
* contraceptive use by men should be consistent with local regulations regarding the use of contraceptive methods for subject participating in clinical studies
* 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

Exclusion Criteria:

* 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 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
* Have smoked tobacco or nicotine-related products within 6 months prior to dosing or does not agree to refrain through Day 113
* 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
* 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

Primary outcomes:
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
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
Secondary outcomes:
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
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
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
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
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
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
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
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
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
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
measure: Part 1 and 3: Immunogenicity of JNJ-64179375
timeFrame: Predose, Day 7, 14, 29, 57, 85 and 113
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
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
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
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
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
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
measure: Part 2: Immunogenicity of JNJ-64179375 in the presence of 4-factor PCC
timeFrame: Predose, Day 7, 14, 29, 57, 85 and 113
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
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
Other outcomes:
Locations:
city: Merksem
country: Belgium
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: