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- Sperimentazione clinica NCT03080987
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Japanese Participants
12 ottobre 2018 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Tipo di studio
Interventistico
Iscrizione (Effettivo)
40
Fase
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Fukuoka, Giappone, 812-0025
- Souseikai Hakata Clinic
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London, Regno Unito, NW10 7EW
- Hammersmith Medicines Research Ltd
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 20 anni a 45 anni (Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
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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).
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Sperimentale: 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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Sperimentale: 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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Sperimentale: 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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Sperimentale: 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.
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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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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Part 1 and 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-64179375
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
27 giugno 2017
Completamento primario (Effettivo)
25 giugno 2018
Completamento dello studio (Effettivo)
25 giugno 2018
Date di iscrizione allo studio
Primo inviato
10 marzo 2017
Primo inviato che soddisfa i criteri di controllo qualità
10 marzo 2017
Primo Inserito (Effettivo)
15 marzo 2017
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
15 ottobre 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
12 ottobre 2018
Ultimo verificato
1 ottobre 2018
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- CR108306
- 2016-004785-25 (Numero EudraCT)
- 64179375EDI1002 (Altro identificatore: Janssen Research & Development, LLC)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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