A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-64991524 in Healthy Participants
22 janvier 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
- Médicament: JNJ-64991524 Dose Level 1
- Médicament: Placebo
- Médicament: JNJ-64991524 Dose Level 2
- Médicament: JNJ-64991524 Dose Level 3
- Médicament: JNJ-64991524 Dose Level 4
- Médicament: JNJ-64991524 Dose Level 5
- Médicament: JNJ-64991524 Dose Level 6
- Médicament: JNJ-64991524 Dose Level 7
- Médicament: JNJ-64991524 Dose Level 8
- Médicament: JNJ-64991524 Dose Level 9
Type d'étude
Interventionnel
Inscription (Réel)
86
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Antwerpen, Belgique, 2060
- SGS Clinical Pharmacology Unit (located in ZNA Stuivenberg)
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 60 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
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Participants will receive JNJ-64991524 at a Dose Level 1 in SAD Part 1 of study.
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
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Expérimental: 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.
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Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Participants will receive JNJ-64991524 at a Dose Level 2 in SAD Part 1 of study.
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Expérimental: 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.
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Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Participants will receive JNJ-64991524 at a Dose Level 3 in SAD Part 1 of study.
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Expérimental: 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.
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Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Participants will receive JNJ-64991524 at a Dose Level 4 in SAD Part 1 of study.
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Expérimental: 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.
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Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Participants will receive JNJ-64991524 at a dose of Dose Level 5 in SAD Part 1 of study.
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Expérimental: 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.
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Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Participants will receive JNJ-64991524 at a Dose Level 6 in SAD Part 1 and MAD part 2 of study.
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Expérimental: 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.
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Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Participants will receive JNJ-64991524 at a dose of Dose Level 7 in MAD Part 2 of study for 14 days.
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Expérimental: 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.
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Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Participants will receive JNJ-64991524 at a Dose Level 8 in MAD Part 2 of study for 14 days.
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Expérimental: 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.
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Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Participants will receive JNJ-64991524 at a Dose Level 9 in MAD Part 2 of study for 14 days.
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Expérimental: 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.
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Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
Participants will receive JNJ-64991524 at a Dose Level 6 in SAD Part 1 and MAD part 2 of study.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Part 1: Single Ascending Dose (SAD): Number of Participants with Treatment Emergent Adverse Events (AEs) as a Measure of Safety and Tolerability
Délai: Up to Day 20
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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.
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.
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Up to Day 20
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Part 2: Multiple Ascending Dose (MAD): Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability
Délai: Up to Day 28
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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.
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.
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Up to Day 28
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Number of Participants with Abnormalities in Vital Signs, Physical Examinations, Electrocardiogram (ECG), Cardiac Telemetry and Clinically Significant Laboratory Findings
Délai: Pre-dose, up to Day 20 (SAD) and up to Day 28 (MAD)
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Number of participants with abnormalities in vital signs, physical examinations, ECG, cardiac telemetry and clinically significant laboratory findings will be measured.
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Pre-dose, up to Day 20 (SAD) and up to Day 28 (MAD)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Plasma Concentration of JNJ-64991524
Délai: Pre-dose, up to Day 20 (SAD) and up to Day 28 (MAD)
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Plasma concentration assessment will be done to characterize the pharmacokinetics (PK) of JNJ-64991524.
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Pre-dose, up to Day 20 (SAD) and up to Day 28 (MAD)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
15 novembre 2017
Achèvement primaire (Réel)
20 novembre 2018
Achèvement de l'étude (Réel)
20 novembre 2018
Dates d'inscription aux études
Première soumission
15 novembre 2017
Première soumission répondant aux critères de contrôle qualité
15 novembre 2017
Première publication (Réel)
17 novembre 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
24 janvier 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
22 janvier 2019
Dernière vérification
1 janvier 2019
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- CR108376
- 2017-000229-11 (Numéro EudraCT)
- 64991524EDI1001 (Autre identifiant: Janssen Research & Development, LLC)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .