- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT03080987
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Japanese Participants
perjantai 12. lokakuuta 2018 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
40
Vaihe
- Vaihe 1
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
-
-
-
Fukuoka, Japani, 812-0025
- Souseikai Hakata Clinic
-
-
-
-
-
London, Yhdistynyt kuningaskunta, NW10 7EW
- Hammersmith Medicines Research Ltd
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
20 vuotta - 45 vuotta (Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Joo
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Kokeellinen: 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).
|
Kokeellinen: 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.
|
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).
|
Kokeellinen: 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.
|
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.
|
Kokeellinen: 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.
|
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).
|
Kokeellinen: 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).
|
Kokeellinen: 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.
|
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).
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Aikaikkuna: Up to Day 113
|
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.
|
Up to Day 113
|
Part 2: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Aikaikkuna: Up to Day 113
|
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.
|
Up to Day 113
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Part 1 and 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-64179375
Aikaikkuna: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
|
Cmax is the maximum observed plasma concentration.
|
Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
|
Part 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of JNJ-64179375
Aikaikkuna: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
|
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
|
Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
|
Part 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-64179375
Aikaikkuna: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
|
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time.
|
Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
|
Part 1: Total Systemic Clearance (CL) of JNJ-64179375
Aikaikkuna: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
|
CL is defined as total systemic clearance after intravenous administration of JNJ-64179375.
|
Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
|
Part 1: Apparent Volume of Distribution at Terminal Phase After Intravenous Administration (Vz) of JNJ-64179375
Aikaikkuna: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
|
Vz is defined as the Apparent volume of distribution at terminal phase after intravenous administration.
|
Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
|
Part 1 and 2: Terminal Half-Life (t1/2) of JNJ-64179375
Aikaikkuna: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
|
Half-life is the time measured for the plasma concentration of drug to decrease by one half.
|
Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
|
Part 2: Total Systemic Clearance Over Bioavailability After Subcutaneous (SC) Administration (CL/F) of JNJ-64179375 post-dose
Aikaikkuna: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
|
CL/F is defined as total systemic clearance over bioavailability after SC administration.
|
Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
|
Part 2: Apparent Volume of Distribution at Terminal Phase Over Bioavailability After Subcutaneous Administration (Vz/F) of JNJ-64179375
Aikaikkuna: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
|
(Vz/F) is defined as Apparent Volume of distribution at terminal phase over bioavailability after SC administration of JNJ-64179375.
|
Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
|
Part 2: Absolute Bioavailability (F) After Subcutaneous Administration of JNJ-64179375
Aikaikkuna: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
|
F is defined as absolute bioavailability after SC administration of JNJ-64179375.
|
Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
|
Part 1 and 2: Immunogenicity of JNJ-64179375
Aikaikkuna: Predose, Day 7, 14, 29, 57, 85 and 113 post-dose
|
Plasma samples will be collected and screened for antibodies binding to JNJ-64179375 and the titer of confirmed positive samples will be reported.
|
Predose, Day 7, 14, 29, 57, 85 and 113 post-dose
|
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Thrombin Time (TT)
Aikaikkuna: Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
|
The pharmacodynamic effect of JNJ-64179375 on coagulation parameters will be assessed by measuring the change in thrombin time (TT).
|
Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
|
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Prothrombin Time (PT)
Aikaikkuna: Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
|
The pharmacodynamic effect of JNJ-64179375 on coagulation parameters will be assessed by measuring the change in prothrombin time (PT).
|
Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
|
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Activated Partial Thromboplastin time (aPTT)
Aikaikkuna: Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
|
The pharmacodynamic effect of JNJ-64179375 on coagulation parameters will be assessed by measuring the change in activated partial thromboplastin time (aPTT).
|
Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
|
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Ecarin Clotting time (ECT)
Aikaikkuna: Predose, Day 1, 2, 4, and 14 post-dose
|
The pharmacodynamic effect of JNJ-64179375 on coagulation parameters will be assessed by measuring the change in Ecarin Clotting time (ECT).
|
Predose, Day 1, 2, 4, and 14 post-dose
|
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 on Platelet Function
Aikaikkuna: Predose, Days 1 and 14 post-dose
|
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.
|
Predose, Days 1 and 14 post-dose
|
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Thrombin Generation Assay (TGA)
Aikaikkuna: Predose, Day 1 and 14 post-dose
|
The TGA is based on the premise that measurements of thrombin generation are indicative of the overall coagulating capacity of the individual.
|
Predose, Day 1 and 14 post-dose
|
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by D-dimer
Aikaikkuna: Predose, Day 1 and 14 post-dose
|
The D-dimer assay is an enzyme immunoassay procedure for the quantitative determination of D-dimer.
|
Predose, Day 1 and 14 post-dose
|
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in International Normalized Ratio (INR)
Aikaikkuna: Predose, Day 1, 2,4, 7, 14, 29, 57 and 113 post-dose
|
The pharmacodynamic effect of JNJ-64179375 on coagulation parameters will be assessed by measuring the change in international normalized ratio (INR).
|
Predose, Day 1, 2,4, 7, 14, 29, 57 and 113 post-dose
|
Part 2: Time to Maximum Observed Plasma Concentration (Tmax) After Subcutaneous Administration of JNJ-64179375
Aikaikkuna: Predose, Day 1, 2,4, 7, 10, 14, 22, 29,43, 57, 85 and 113 post-dose
|
The Tmax is defined as actual sampling time to reach maximum observed plasma concentration.
|
Predose, Day 1, 2,4, 7, 10, 14, 22, 29,43, 57, 85 and 113 post-dose
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Tiistai 27. kesäkuuta 2017
Ensisijainen valmistuminen (Todellinen)
Maanantai 25. kesäkuuta 2018
Opintojen valmistuminen (Todellinen)
Maanantai 25. kesäkuuta 2018
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Perjantai 10. maaliskuuta 2017
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Perjantai 10. maaliskuuta 2017
Ensimmäinen Lähetetty (Todellinen)
Keskiviikko 15. maaliskuuta 2017
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Maanantai 15. lokakuuta 2018
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Perjantai 12. lokakuuta 2018
Viimeksi vahvistettu
Maanantai 1. lokakuuta 2018
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muut tutkimustunnusnumerot
- CR108306
- 2016-004785-25 (EudraCT-numero)
- 64179375EDI1002 (Muu tunniste: Janssen Research & Development, LLC)
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Ei
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
Yhdysvalloissa valmistettu ja sieltä viety tuote
Ei
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
Kliiniset tutkimukset JNJ-64179375 0.3 mg/kg
-
Janssen Research & Development, LLCValmisVTE-profylaksia antikoagulaatiolla täydellisen polven tekonivelleikkauksen jälkeenBelgia, Italia, Malesia, Latvia, Espanja, Turkki, Bulgaria, Yhdysvallat, Liettua, Venäjän federaatio, Ukraina, Japani, Argentiina, Brasilia, Kanada, Puola
-
Janssen Research & Development, LLCValmisHengitysteiden synsytialiset viruksetTaiwan, Belgia, Yhdistynyt kuningaskunta, Argentiina, Panama
-
Janssen Research & Development, LLCLopetettuHengitysteiden infektiotBelgia, Tšekki, Taiwan, Japani, Unkari, Thaimaa, Yhdysvallat, Saksa, Korean tasavalta, Turkki, Kiina, Espanja, Brasilia, Bulgaria, Malesia, Viro, Argentiina, Puola, Israel, Italia, Latvia, Meksiko, Panama, Slovakia, Ruotsi, Ukraina
-
Janssen Research & Development, LLCValmis
-
Janssen Research & Development, LLCValmis
-
Johnson & Johnson Pharmaceutical Research & Development...ValmisSydämen vajaatoimintaBelgia, Saksa, Puola, Romania
-
Janssen-Cilag International NVValmis
-
Janssen Research & Development, LLCValmis
-
Janssen Pharmaceutical K.K.Valmis
-
Janssen Research & Development, LLCLopetettuAlzheimerin tautiRanska, Espanja, Alankomaat, Belgia, Saksa, Ruotsi