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A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-64991524 in Healthy Participants

22 januari 2019 bijgewerkt door: Janssen Research & Development, LLC

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of JNJ-64991524 in Healthy Participants

The purpose of this study is to evaluate safety and tolerability of JNJ-64991524 compared with placebo after administration of single ascending oral doses of JNJ-64991524 (Part 1) and multiple ascending oral doses of JNJ-64991524 (Part 2) in healthy participants.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

86

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • België
      • Antwerpen, België, 2060
        • SGS Clinical Pharmacology Unit (located in ZNA Stuivenberg)

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 60 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Weigh at least 50 kilogram (kg), and have a body mass index (BMI) of 18 kg/ meter (m)^2 to 30 kg/m^2, inclusive, at screening
  • Be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening and Day-1. This determination must be recorded in the participant's source documents and initialed by the investigator
  • Be otherwise healthy on the basis of clinical laboratory tests performed at screening and Day -1. If the results of the serum chemistry panel, including liver enzymes, white blood cell count and hematocrit, coagulation, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and confirmed initialed by the investigator
  • Have the platelet count pretreatment clinical laboratory values not below the normal range during Screening and Day -1
  • A woman must have a negative serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test on Day -2

Exclusion Criteria:

  • History of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
  • Known allergies, hypersensitivity, or intolerance to JNJ-64991524 or its excipients
  • History of severe allergic reaction, angioedema, or anaphylaxis to drugs or food
  • Has a history of malignancy before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered cured with minimal risk of recurrence
  • Has a history of or is infected with human immunodeficiency virus (HIV [positive serology for HIV antibody]); tests positive for hepatitis B virus (HBV) infection; has antibodies to hepatitis C virus (HCV) at screening

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Cohort 1:JNJ-64991524 Dose Level (DL) 1 or Placebo(SAD Part 1)
Participants will receive a single oral dose (Dose level 1) of either JNJ-64991524 or placebo capsules after an overnight fast (at least 10 hours) on Day 1 of Part 1.
Geneesmiddel: JNJ-64991524 Dose Level 1
Participants will receive JNJ-64991524 at a Dose Level 1 in SAD Part 1 of study.
Geneesmiddel: Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Experimenteel: Cohort 2: JNJ-64991524 DL 2 or Placebo (SAD Part 1)
Participants will receive a single oral dose (Dose level 2) of either JNJ-64991524 or placebo capsules after an overnight fast (at least 10 hours) on Day 1 of Part 1.
Geneesmiddel: Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Geneesmiddel: JNJ-64991524 Dose Level 2
Participants will receive JNJ-64991524 at a Dose Level 2 in SAD Part 1 of study.
Experimenteel: Cohort 3: JNJ-64991524 DL 3 or Placebo (SAD Part 1)
Participants will receive a single oral dose (Dose level 3) of either JNJ-64991524 or placebo capsules after an overnight fast (at least 10 hours) on Day 1 of Part 1.
Geneesmiddel: Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Geneesmiddel: JNJ-64991524 Dose Level 3
Participants will receive JNJ-64991524 at a Dose Level 3 in SAD Part 1 of study.
Experimenteel: Cohort 4:JNJ-64991524 DL 4 or Placebo (SAD Part 1:Fasted-Fed)
Participants will receive a single oral dose (Dose level 4) of either JNJ-64991524 or placebo capsules in a fasted condition on Day 1 and fed condition, on Day 7.
Geneesmiddel: Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Geneesmiddel: JNJ-64991524 Dose Level 4
Participants will receive JNJ-64991524 at a Dose Level 4 in SAD Part 1 of study.
Experimenteel: Cohort 5: JNJ-64991524 DL 5 or Placebo (SAD Part 1)
Participants will receive a single oral dose (Dose level 5) of JNJ-64991524 or placebo after an overnight fast (at least 10 hours) on Day 1 of Part 1.
Geneesmiddel: Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Geneesmiddel: JNJ-64991524 Dose Level 5
Participants will receive JNJ-64991524 at a dose of Dose Level 5 in SAD Part 1 of study.
Experimenteel: Cohort 6: JNJ-64991524 DL 6 or Placebo (SAD Part 1)
Participants will receive a single oral dose (Dose level 6) of JNJ-64991524 or placebo after an overnight fast (at least 10 hours) on Day 1 of Part 1.
Geneesmiddel: Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Geneesmiddel: JNJ-64991524 Dose Level 6
Participants will receive JNJ-64991524 at a Dose Level 6 in SAD Part 1 and MAD part 2 of study.
Experimenteel: Cohort 1: JNJ-64991524 DL 7 or Placebo (MAD Part 2)
Participants will receive an oral dose (Dose level 7) JNJ-64991524 or placebo capsules once daily for 14 days in fasted or fed condition in Part 2. Fasted/fed condition will be determined based on tolerability and pharmacokinetics (PK) from Part 1.
Geneesmiddel: Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Geneesmiddel: JNJ-64991524 Dose Level 7
Participants will receive JNJ-64991524 at a dose of Dose Level 7 in MAD Part 2 of study for 14 days.
Experimenteel: Cohort 2: JNJ-64991524 DL 8 or Placebo (MAD Part 2)
Participants will receive an oral dose (Dose level 8) JNJ-64991524 or placebo capsules once daily for 14 days in fasted or fed condition in Part 2. Fasted/fed condition will be determined based on tolerability and PK from Part 1.
Geneesmiddel: Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Geneesmiddel: JNJ-64991524 Dose Level 8
Participants will receive JNJ-64991524 at a Dose Level 8 in MAD Part 2 of study for 14 days.
Experimenteel: Cohort 3: JNJ-64991524 DL 9 or Placebo (MAD Part 2)
Participants will receive an oral dose (Dose level 9) JNJ-64991524 or placebo capsules once daily for 14 days in fasted or fed condition in Part 2. Fasted/fed condition will be determined based on tolerability and PK from Part 1.
Geneesmiddel: Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Geneesmiddel: JNJ-64991524 Dose Level 9
Participants will receive JNJ-64991524 at a Dose Level 9 in MAD Part 2 of study for 14 days.
Experimenteel: Cohort 4: JNJ-64991524 DL 6 or Placebo (MAD Part 2)
Participants will receive an oral dose (Dose level 6) of JNJ-64991524 or placebo capsules once daily for 14 days in fasted or fed condition in Part 2. Fasted/fed condition will be determined by tolerability and PK from Part 1.
Geneesmiddel: Placebo
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Geneesmiddel: JNJ-64991524 Dose Level 6
Participants will receive JNJ-64991524 at a Dose Level 6 in SAD Part 1 and MAD part 2 of study.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Part 1: Single Ascending Dose (SAD): Number of Participants with Treatment Emergent Adverse Events (AEs) as a Measure of Safety and Tolerability
Tijdsspanne: Up to Day 20
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. Treatment-emergent were events between administration of study drug and up to Day 20 that were absent before treatment or that worsened relative to pre-treatment state.
Up to Day 20
Part 2: Multiple Ascending Dose (MAD): Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability
Tijdsspanne: Up to Day 28
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. Treatment-emergent were events between administration of study drug and up to Day 28 that were absent before treatment or that worsened relative to pre-treatment state.
Up to Day 28
Number of Participants with Abnormalities in Vital Signs, Physical Examinations, Electrocardiogram (ECG), Cardiac Telemetry and Clinically Significant Laboratory Findings
Tijdsspanne: Pre-dose, up to Day 20 (SAD) and up to Day 28 (MAD)
Number of participants with abnormalities in vital signs, physical examinations, ECG, cardiac telemetry and clinically significant laboratory findings will be measured.
Pre-dose, up to Day 20 (SAD) and up to Day 28 (MAD)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Plasma Concentration of JNJ-64991524
Tijdsspanne: Pre-dose, up to Day 20 (SAD) and up to Day 28 (MAD)
Plasma concentration assessment will be done to characterize the pharmacokinetics (PK) of JNJ-64991524.
Pre-dose, up to Day 20 (SAD) and up to Day 28 (MAD)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Janssen Research & Development, LLC

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 november 2017

Primaire voltooiing (Werkelijk)

20 november 2018

Studie voltooiing (Werkelijk)

20 november 2018

Studieregistratiedata

Eerst ingediend

15 november 2017

Eerst ingediend dat voldeed aan de QC-criteria

15 november 2017

Eerst geplaatst (Werkelijk)

17 november 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 januari 2019

Laatste update ingediend die voldeed aan QC-criteria

22 januari 2019

Laatst geverifieerd

1 januari 2019

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • CR108376
  • 2017-000229-11 (EudraCT-nummer)
  • 64991524EDI1001 (Andere identificatie: Janssen Research & Development, LLC)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Gezond

Klinische onderzoeken op JNJ-64991524 Dose Level 1

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Voorwaarden

Zeldzame ziekten

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