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HealthyPhase 1NCT02949206

A Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Male Subjects

A Phase 1 study testing JNJ-64179375 and 4 Factor Prothrombin Complex Concentrate (PCC) in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
JNJ-64179375 and 4 Factor Prothrombin Complex Concentrate (PCC)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteBelgium
Study dates
14 Nov 2016to 9 Aug 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Study site

    Merksem

Other trials in Belgium

About this study

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

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.

Conditions
Healthy
Being tested
JNJ-64179375, Placebo, 4 Factor Prothrombin Complex Concentrate (PCC)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-64179375Drug

    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.

  • PlaceboDrug

    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).

  • 4 Factor Prothrombin Complex Concentrate (PCC)Drug

    Following a single dose of JNJ-64179375, participants will receive a single IV dose of 4 factor-PCC.

Study groups in NCT02949206
Study groupRoleWhat they receive
Part 1: Cohort 1 (0.03 mg/kg of JNJ-64179375 or Placebo)ExperimentalParticipants 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.
Receives: Drug: JNJ-64179375; Drug: Placebo
Part 1: Cohort 2 (0.1 mg/kg of JNJ-64179375 or Placebo)ExperimentalParticipants 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.
Receives: Drug: JNJ-64179375; Drug: Placebo
Part 1: Cohort 3 (0.3 mg/kg of JNJ-64179375 or Placebo)ExperimentalParticipants 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.
Receives: Drug: JNJ-64179375; Drug: Placebo
Part 1: Cohort 4 (1.0 mg/kg of JNJ-64179375 or Placebo)ExperimentalParticipants 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.
Receives: Drug: JNJ-64179375; Drug: Placebo
Part 1: Cohort 5 (2.5 mg/kg of JNJ-64179375 or Placebo)ExperimentalParticipants 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.
Receives: Drug: JNJ-64179375; Drug: Placebo
Part 1: Cohort 6 (5.0 mg/kg of JNJ-64179375 or Placebo)ExperimentalParticipants 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.
Receives: Drug: JNJ-64179375; Drug: Placebo
Part 1: Cohort 7 (Escalation Dose of JNJ-64179375 or Placebo)ExperimentalDose escalation will proceed until the toxicology study exposure limits or a highest tolerable dose will be reached.
Receives: Drug: JNJ-64179375; Drug: Placebo
Part 1: Cohort 8 (Escalation Dose of JNJ-64179375 or Placebo)ExperimentalDose escalation will proceed until the toxicology study exposure limits or a highest tolerable dose will be reached.
Receives: Drug: JNJ-64179375; Drug: Placebo
Part 2: Reversal Cohort :(50 IU/kg of 4-factor PCC)ExperimentalParticipants 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.
Receives: Drug: JNJ-64179375; Drug: Placebo; Drug: 4 Factor Prothrombin Complex Concentrate (PCC)
Part 3: Subcutaneous Cohort (1.0 mg/kg of JNJ-64179375)ExperimentalParticipants 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.
Receives: Drug: JNJ-64179375; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability

    Measured: Up to Day 113

  2. Part 3: Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability

    Measured: Up to Day 113

  3. Part 2: Change From Baseline in Potential for Reversibility of the JNJ-64179375 Induced Pharmacodynamic Effects on Coagulation Parameters

    Change in Potential for Reversibility of the JNJ-64179375 will be assessed by assessing the change in thrombin time as coagulation parameter.

    Measured: Baseline and Day 1

  4. Part 2: Change From Baseline in Potential for Reversibility of the JNJ-64179375 Induced Pharmacodynamic Effects on Platelet Function

    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.

    Measured: Baseline and Day 1

Secondary outcomes (21)

  1. Part 1 and 3: Maximum Observed Plasma Concentration (Cmax) of JNJ-64179375

    Cmax is defined as maximum observed plasma concentration of JNJ-64179375.

    Measured: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113

  2. 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

    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.

    Measured: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113

  3. Part 1 and 3: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-64179375

    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.

    Measured: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113

  4. Part 1 and 3: Terminal Half-Life (t1/2) of JNJ-64179375

    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).

    Measured: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113

  5. Part 1: Total Systemic Clearance (CL) of JNJ-64179375

    CL is defined as total systemic clearance after intravenous administration of JNJ-64179375.

    Measured: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113

  6. Part 1: Apparent Volume of Distribution at Terminal Phase After Intravenous Administration (Vz) of JNJ-64179375

    Vz is defined as the Apparent volume of distribution at terminal phase after intravenous administration.

    Measured: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113

  7. Part 3: Time to Reach Maximum Observed Concentration (Tmax) of JNJ-64179375

    Tmax is defined as time to the maximum observed plasma concentration of JNJ-64179375.

    Measured: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113

  8. Part 3: Total Systemic Clearance Over Bioavailability After Subcutaneous (SC) Administration (CL/F) of JNJ-64179375

    CL/F is defined as total systemic clearance over bioavailability after SC administration.

    Measured: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113

  9. Part 3: Apparent Volume of Distribution at Terminal Phase Over Bioavailability After Subcutaneous Administration (Vz/F) of JNJ-64179375

    (Vz/F) is defined as Apparent Volume of distribution at terminal phase over bioavailability after SC administration of JNJ-64179375.

    Measured: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113

  10. Part 3: Absolute Bioavailability (F) After Subcutaneous Administration of JNJ-64179375

    F is defined as absolute bioavailability after SC administration of JNJ-64179375.

    Measured: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113

  11. Part 1 and 3: Immunogenicity of JNJ-64179375

    Plasma samples will be collected and screened for antibodies binding to JNJ-64179375 and the titer of confirmed positive samples will be reported.

    Measured: Predose, Day 7, 14, 29, 57, 85 and 113

  12. Part 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-64179375 in presence of 4-factor prothrombin complex concentrate (PCC)

    Cmax is defined as maximum observed plasma concentration of JNJ-64179375.

    Measured: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113

  13. 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

    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

    Measured: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113

  14. 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

    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.

    Measured: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113

  15. Part 2: Terminal Half Life [t(1/2)] of JNJ-64179375 in the presence of 4-factor PCC

    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).

    Measured: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113

  16. Part 2: Total Systemic Clearance (CL) of JNJ-64179375 in the presence of 4-factor PCC

    CL is defined as total systemic clearance after intravenous administration of JNJ-64179375.

    Measured: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113

  17. Part 2: Apparent Volume of Distribution at Terminal Phase After Intravenous Administration (Vz) of JNJ-64179375 in the presence of 4-factor PCC

    Vz is defined as the Apparent volume of distribution at terminal phase after intravenous administration.

    Measured: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113

  18. Part 2: Immunogenicity of JNJ-64179375 in the presence of 4-factor PCC

    Plasma samples will be collected and screened for antibodies binding to JNJ-64179375 and the titer of confirmed positive samples will be reported.

    Measured: Predose, Day 7, 14, 29, 57, 85 and 113

  19. Part 2: Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability

    Measured: Baseline to End of treatment (Day 113)

  20. Part 1 and 3: Pharmacodynamic Effect of JNJ-64179375 on Platelet Function

    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.

    Measured: Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113

  21. Part 1 and 3: Pharmacodynamic Effect of JNJ-64179375 on Coagulation Parameters

    The pharmacodynamic effect of JNJ-64179375 on coagulation parameters will be assessed by measuring the change in thrombin time.

    Measured: Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2016 (estimated)
  2. Study start14 Nov 2016
  3. Primary completion9 Aug 2017
  4. Study completion9 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02949206
Sponsor's protocol ID
CR108238
Other IDs
64179375EDI1001, 2016-003006-13, 2016
Status last verified
Sep 2017
First submitted
27 Oct 2016
Last updated
25 Sep 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-64179375 and 4 Factor Prothrombin Complex Concentrate (PCC) in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability (time frame: Up to Day 113). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02949206.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.

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