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A Study to Evaluate the Pharmacokinetics of JNJ-56021927 in Participants With Mild or Moderate Hepatic Impairment Compared With Participants With Normal Hepatic Function

17 mai 2019 mis à jour par: Aragon Pharmaceuticals, Inc.

A Single-Dose, Open-Label Study to Evaluate the Pharmacokinetics of JNJ-56021927 in Subjects With Mild or Moderate Hepatic Impairment Compared With Subjects With Normal Hepatic Function

The purpose of this study is to characterize the pharmacokinetics of JNJ-56021927 in participants with mild and moderate hepatic impairment.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

This is an open-label (all people know the identity of the intervention), single-dose, single-center, non-randomized study of JNJ-56021927 in participants who either have hepatic impairment or qualify for the control group. The study consists of 3 Phases: Screening Phase (21 Days), open-label treatment Phase (8 Days) and follow up Phase (49 Days). The duration of participation in the study for each participant is approximately 78 Days. Primarily the pharmacokinetics of JNJ-56021927 will be measured. Participants' safety will be monitored throughout the study.

Type d'étude

Interventionnel

Inscription (Réel)

24

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

    • Tennessee
      • Knoxville, Tennessee, États-Unis
    • Texas
      • San Antonio, Texas, États-Unis

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 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Homme

La description

Inclusion Criteria:

  • Must have a clinically stable hepatic function as confirmed by the serum bilirubin and transaminase levels measured during Screening and those measured within 24 hours prior to study drug administration
  • Sign an informed consent document indicating that the participant understands the purpose of and procedures required for the study and are willing to participate in the study. Participants must not have hepatic encephalopathy greater than or equal to (>=) Grade 3 where the participant lacks the capacity to provide informed consent as judged by the investigator. Mild or moderate hepatic encephalopathy that would not impede informed consent in the investigator's judgment is permitted
  • Willing and able to adhere to the prohibitions and restrictions as specified in the protocol
  • If a man is sexually active with a woman of childbearing potential and has not had a vasectomy, he must agree to use an adequate contraception method as deemed appropriate by the Investigator, always use a condom during sexual intercourse, and agree to not donate sperm during the study and for 3 months after receiving the study drug
  • Body mass index (BMI) between 18 and 35 kilogram (kg)/meter (m)^2 (inclusive), and body weight not less than 50 kg
  • The participant must have a total Child-Pugh score of 5 to 6, inclusive (mild); or 7 to 9, inclusive (moderate); the investigator will determine hepatic impairment

Exclusion Criteria:

  • Screening thyroid-stimulating hormone (TSH) level greater than (>) Upper Limit of Normal (ULN), or participants with known history of thyroid disorders
  • Participant who is on thyroid replacement therapy
  • History of drug abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition) (DSM-IV) criteria within 2 years before Screening or positive test result(s) for drugs of abuse (that is, opiates, barbiturates, benzodiazepines, cocaine, cannabinoids, and amphetamines) at Screening or Day -1. A positive test for participants with prescriptions for drugs that may interfere with the drug screen (that is, opiates and benzodiazepines) may be allowed
  • Known allergy to the study drug or any of the excipients of the formulation
  • Intention to donate blood or blood products during the study or for 3 months after the administration of the study drug
  • A man who plans to father a child while enrolled in the study or for 3 months after receiving the study drug
  • Known history of seizure or condition that may predispose to seizure or on medication that lowers seizure threshold
  • History of stomach or intestinal surgery or resection that would potentially alter absorption or excretion of orally administered drugs
  • Gall bladder (example, cholecystitis and cholelithiasis) or biliary tract disease
  • Clinically significant renal laboratory findings including serum creatinine level greater than (>) 1.5 times ULN
  • Inability to fast for 12 hours
  • History of or current clinically significant medical illness
  • Positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies

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: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: JNJ-56021927
Participants with mild and moderate hepatic impairment and with normal hepatic function will receive JNJ-56021927 240 milligram (mg) orally once on Day 1.
Participants will receive JNJ-56021927 240 milligram (mg) orally once on Day 1.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Maximum Plasma Concentration (Cmax) of JNJ-56021927
Délai: Pre-dose up to 1344 hours post-dose
The Cmax is the maximum observed plasma concentration of JNJ-56021927.
Pre-dose up to 1344 hours post-dose
Maximum Plasma Concentration Corrected for Unbound Fraction (Cmax_unb) of JNJ-56021927
Délai: Pre-dose up to 1344 hours post-dose
The Cmax_unb is the maximum observed plasma concentration corrected for unbound fraction of JNJ-56021927.
Pre-dose up to 1344 hours post-dose
Time to Reach the Maximum Plasma Concentration (Tmax) of JNJ-56021927
Délai: Pre-dose up to 1344 hours post-dose
The Tmax is the time to reach the maximum observed plasma concentration of JNJ-56021927.
Pre-dose up to 1344 hours post-dose
Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC[0-24]) Post Dose of JNJ-56021927
Délai: Pre-dose up to 1344 hours post-dose
The AUC(0-24hrs) is the area under the plasma concentration-time curve from 0 to 24 hours post dosing.
Pre-dose up to 1344 hours post-dose
Area Under the Plasma Concentration-Time Curve From 0 to 168 Hours (AUC[0-168]) Post Dose of JNJ-56021927
Délai: Pre-dose up to 1344 hours post-dose
The AUC(0-168hrs) is the area under the plasma concentration-time curve from 0 to 168 hours post dosing.
Pre-dose up to 1344 hours post-dose
Area Under the Plasma Concentration-Time Curve From 0 to Last Quantifiable Concentration (AUC[0-last]) Post Dose of JNJ-56021927
Délai: Pre-dose up to 1344 hours post-dose
The AUC(0-last) is the area under the plasma concentration-time curve from 0 to time of the last quantifiable concentration.
Pre-dose up to 1344 hours post-dose
Area Under the Plasma Concentration-Time Curve From 0 to Last Quantifiable Concentration Corrected for Unbound Fraction (AUC[last_unb]) Post Dose of JNJ-56021927
Délai: Pre-dose up to 1344 hours post-dose
The AUC(last_unb) corrected for unbound fraction is the area under the plasma concentration-time curve from 0 to time of the last quantifiable concentration.
Pre-dose up to 1344 hours post-dose
Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time (AUC[0-infinity]) Post Dose of JNJ-56021927
Délai: Pre-dose up to 1344 hours post-dose
The AUC (0-infinity) is the area under the plasma JNJ-56021927 concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma JNJ-56021927 concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed quantifiable concentration and lambda(z) is elimination rate constant.
Pre-dose up to 1344 hours post-dose
Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time Corrected for Unbound Fraction (AUC[infinity_unb]) Post Dose of JNJ-56021927
Délai: Pre-dose up to 1344 hours post-dose
The AUC(infinity_unb) is the area under the plasma JNJ-56021927 concentration-time curve from time 0 to infinite time corrected for unbound fraction, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma JNJ-56021927 concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed quantifiable concentration and lambda(z) is elimination rate constant.
Pre-dose up to 1344 hours post-dose
Percentage of Area Under the Plasma Concentration-Time Curve Obtained by Extrapolation (%AUC[infinity,ex])
Délai: Pre-dose up to 1344 hours post-dose
The %AUC[infinity,ex] is calculated by dividing the difference of AUC(0-infinity) and AUC(0-last) by AUC(0-infinity) and then multiplying by 100, (AUC[0-infinity] - AUC[0-last])*100/AUC[0-infinity].
Pre-dose up to 1344 hours post-dose
Terminal Half-life (t[1/2]) of JNJ-56021927
Délai: Pre-dose up to 1344 hours post-dose
Elimination half-life associated with the terminal slope Lambda (z) of the semi logarithmic drug concentration-time curve, calculated as 0.693/Lambda (z).
Pre-dose up to 1344 hours post-dose
Elimination Rate Constant (Lambda [z]) of JNJ-56021927
Délai: Pre-dose up to 1344 hours post-dose
The Lambda (z) determined by first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Pre-dose up to 1344 hours post-dose
Time of Last Measurable Plasma Concentration (Tlast) of JNJ-56021927
Délai: Pre-dose up to 1344 hours post-dose
Time to last measurable plasma concentration is evaluated.
Pre-dose up to 1344 hours post-dose
Total Apparent Clearance (CL/F) of JNJ-56021927
Délai: Pre-dose up to 1344 hours post-dose
The CL/F is defined as Dose/AUC (0-infinity).
Pre-dose up to 1344 hours post-dose
Apparent Volume of Distribution (Vd/F) of JNJ-56021927
Délai: Pre-dose up to 1344 hours post-dose
The Vd/F is defined as Dose/[Lambda (z)*AUC (0-infinity)].
Pre-dose up to 1344 hours post-dose
Metabolite to Parent Drug Ratio for Maximum Observed Plasma Concentration (MPR Cmax)
Délai: Pre-dose up to 1344 hours post-dose
The (MPR Cmax) is metabolite to parent drug ratio for maximum observed plasma concentration.
Pre-dose up to 1344 hours post-dose
Metabolite to Parent Drug Ratio for Area Under the Plasma Concentration-Time Curve From Time 0 to Last Observed Quantifiable Concentration (MPR AUC[0-last])
Délai: Pre-dose up to 1344 hours post-dose
The MPR AUClast is metabolite to parent drug ratio for area under the plasma concentration-time curve from time 0 to last quantifiable concentration (AUC [0-last]).
Pre-dose up to 1344 hours post-dose
Metabolite to Parent Drug Ratio for Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (MPR AUC [0-infinity])
Délai: Pre-dose up to 1344 hours post-dose
The MPR AUC [0-infinity] is metabolite to parent drug ratio for area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUC [0-infinity]).
Pre-dose up to 1344 hours post-dose

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of Participants with Adverse Events (AEs) and Serious AEs
Délai: Screening up to follow-up (56 days after dose administration)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Screening up to follow-up (56 days after dose administration)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

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)

13 août 2015

Achèvement primaire (Réel)

9 février 2017

Achèvement de l'étude (Réel)

9 février 2017

Dates d'inscription aux études

Première soumission

13 août 2015

Première soumission répondant aux critères de contrôle qualité

13 août 2015

Première publication (Estimation)

17 août 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

21 mai 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 mai 2019

Dernière vérification

1 mai 2019

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CR107774
  • 56021927PCR1018 (Autre identifiant: Janssen Research & Development, LLC)

Informations sur les médicaments et les dispositifs, documents d'étude

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 .

Essais cliniques sur JNJ-56021927

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