- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04474210
A Study to Evaluate the Effect of Renal Impairment on JNJ-56136379 in Adult Participants
An Open-Label, Single-Dose Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-56136379 in Adult Participants
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Florida
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Orlando, Florida, États-Unis, 32809
- Orlando Clinical Research Center
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Texas
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San Antonio, Texas, États-Unis, 78215
- The Texas Liver Institute
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Body mass index (BMI) (kilograms [kg]/height [m]^2) between 18.0 and 38.0 kilogram/meter^2 (kg/m2) (inclusive), and body weight not less than (<) 50 kg
Participants with normal renal function:
- Have normal renal function defined as estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 90 milliliter/minute computed with the online calculator on the CKD-EPI website by use of the Chronic Kidney Disease Epidemiology Collaboration creatinine clearance (CKD-EPIcr) result
- Must have stable renal function as defined as: (a) for participants with impaired renal function: <20 percent (%) change in serum creatinine concentrations between screening and Day -1; (b) for healthy participants: a change in serum creatinine concentration <0.2 milligram per deciliter (mg/dL) between screening and Day -1
Participants with renal impairment:
- Have an impaired renal function based on eGFR as(eGFR computed with the online calculator on the CKD-EPI website providing eGFR (in mL/min units) by use of the CKD-EPIcr result: (a) eGFR <90 to 60 mL/minute for participants in Group 3 (mild renal impairment cohort); (b) eGFR 30 to 59 mL/minute for participants in Group 4 (moderate renal impairment cohort); (c) eGFR <30 mL/minute but not yet on hemodialysis, for participants in Group 1 (severe renal impairment and/or kidney failure); (d) eGFR <15 mL/minute and on hemodialysis, for participants in Group 5 (kidney failure)
- Concomitant medications to treat underlying disease states or medical conditions related to renal impairment are allowed. Participants must be on a stable dose of medication and/or treatment regimen for at least 2 months (3 months for thyroid hormone replacement therapy [HRT]) before dosing as well as during the study
Exclusion Criteria:
- Individuals who take creatine supplements, have a non-standard muscle mass such as amputation, malnutrition, or muscle wasting; because these factors are not accounted for in the prediction equations for GFR chronic kidney disease epidemiology collaboration (CKD EPI)
Participants with normal renal function:
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or Day -1, as deemed appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs, body temperature, or 12 lead ECG at screening or Day -1, as deemed appropriate by the investigator
Participants with renal impairment:
- Evidence of clinically apparent concurrent disease based upon complete clinical laboratory testing, full physical examination, or medical history, except for controlled hypertension and those problems directly associated with the primary diagnosis of renal impairment
- Any clinically significant laboratory abnormality except abnormalities that may be caused by renal impairment
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Part A: Group 1
Participants with severe renal impairment and/or kidney failure (estimated glomerular filtration rate [eGFR] less than [<] 30 milliliter[mL]/minute but not yet on hemodialysis) will receive a single oral dose of JNJ-56136379.
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Participants will receive JNJ-56136379 tablets orally.
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Comparateur actif: Part A: Group 2
Healthy participants with normal renal function (eGFR greater than or equal to [>=] 90 mL/minute), will receive a single oral dose of JNJ-56136379.
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Participants will receive JNJ-56136379 tablets orally.
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Expérimental: Part B: Group 3 (Optional)
Participants with mild renal impairment (eGFR: 60 to 89 mL/minute) will receive a single oral dose of JNJ-56136379.
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Participants will receive JNJ-56136379 tablets orally.
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Expérimental: Part B: Group 4 (Optional)
Participants with moderate renal impairment (eGFR: 30 to 59 mL/minute) will receive a single oral dose of JNJ-56136379.
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Participants will receive JNJ-56136379 tablets orally.
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Expérimental: Part B: Group 5 (Optional)
Participants with kidney failure (eGFR: <15 mL/minute and on hemodialysis; pharmacokinetic [PK] to be evaluated during non-dialysis days) will receive a single oral dose of JNJ-56136379.
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Participants will receive JNJ-56136379 tablets orally.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Maximum Observed Plasma Analyte Concentration (Cmax)
Délai: Up to Day 29
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Cmax is defined as the maximum observed plasma analyte concentration.
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Up to Day 29
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Time to Reach the Maximum Observed Plasma Analyte Concentration (Tmax)
Délai: Up to Day 29
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Tmax is defined as the actual sampling time to reach the maximum observed plasma analyte concentration.
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Up to Day 29
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Area Under the Analyte Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC [0-24])
Délai: Up to 24 hours postdose
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AUC (0-24) is defined as area under the analyte concentration-time curve (AUC) from time 0 to 24 hours postdose, calculated by linear-linear trapezoidal summation.
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Up to 24 hours postdose
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Area Under the Analyte Concentration-time Curve From Time Zero to 144 Hours Postdose (AUC [0-144])
Délai: Up to 144 hours postdose
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AUC (0-144) is defined as AUC from time 0 to 144 hours postdose, calculated by linear-linear trapezoidal summation.
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Up to 144 hours postdose
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Area Under the Analyte Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC [0-last])
Délai: Up to Day 29
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AUC (0-last) is defined as AUC from time 0 to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation.
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Up to Day 29
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Area Under the Analyte Concentration-time Curve From Time Zero to Infinity (AUC [0-infinity])
Délai: Up to Day 29
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AUC (0-infinity) is defined as AUC from time 0 to infinity, calculated as the sum of AUC (0-last) and C(last)/lambda(z); where C(last) is the last observed measurable (non-BQL) concentration; and lambda(z) is apparent terminal elimination rate constant.
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Up to Day 29
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Total Apparent Oral Clearance (CL/F)
Délai: Up to Day 29
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CL/F is defined as total apparent oral clearance, calculated as dose/AUC (0-infinity).
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Up to Day 29
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Apparent Volume of Distribution (Vd/F)
Délai: Up to Day 29
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Vd/F is defined as apparent volume of distribution, calculated as dose/[lambda (z)*AUC (0-infinity)].
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Up to Day 29
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Apparent Terminal Elimination Rate Constant (Lambda[z])
Délai: Up to Day 29
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Lambda(z) is defined as apparent terminal elimination rate constant, estimated by linear regression using the terminal log-linear phase of the log-transformed concentration vs time curve.
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Up to Day 29
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Apparent Terminal Elimination Half-life (t1/2)
Délai: Up to Day 29
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t1/2 is defined as apparent terminal elimination half-life, calculated as 0.693/lambda(z).
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Up to Day 29
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Percentage of JNJ-56136379 Excreted in Urine (Ae,%Dose)
Délai: Up to Day 7
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Ae,%Dose is defined as cumulative urinary recovery represented as a percentage of dose, calculated as 100*(Aetotal/Dose).
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Up to Day 7
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Renal Clearance (CLr)
Délai: Up to 144 hours postdose
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CLr is defined as renal clearance, calculated as Ae(0-144h)/AUC(144h).
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Up to 144 hours postdose
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Nombre de participants avec des événements indésirables comme mesure de sécurité et de tolérabilité
Délai: Jusqu'à 8 semaines
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Un EI est tout événement médical indésirable qui survient chez un participant auquel un produit expérimental a été administré, et il n'indique pas nécessairement uniquement des événements ayant une relation causale claire avec le produit expérimental concerné.
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Jusqu'à 8 semaines
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CR108802
- 56136379HPB1010 (Autre identifiant: Janssen Research & Development, LLC)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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-56136379
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Janssen Sciences Ireland UCComplétéHépatite B chroniqueBelgique, États-Unis, Japon, Corée, République de, France, Hong Kong, Canada, Italie, Thaïlande, Allemagne, Malaisie, Espagne, Fédération Russe, Turquie, Royaume-Uni, Pologne, Brésil, Tchéquie, Chine
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Janssen Research & Development, LLCComplétéEn bonne santéÉtats-Unis
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Janssen Sciences Ireland UCComplétéHépatite BÉtats-Unis, Corée, République de, France, Belgique, Italie, Taïwan, Royaume-Uni, Thaïlande, Malaisie, Chine, Espagne, Canada, Allemagne, Japon, Fédération Russe, Turquie, Ukraine, Pologne, Hong Kong
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Janssen Sciences Ireland UCComplétéEn bonne santé | Hépatite chroniqueFrance, Taïwan, Espagne, Belgique, Bulgarie, Malaisie, Roumanie, Allemagne, Géorgie, Moldavie, République de
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Janssen Research & Development, LLCComplété
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Janssen Sciences Ireland UCComplétéInsuffisance hépatiqueAllemagne
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Janssen Sciences Ireland UCComplétéHépatite B chroniqueBelgique, Royaume-Uni, France, Italie, Allemagne, Espagne, Pologne
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Janssen Research & Development, LLCComplétéHépatite B chroniqueFrance, Taïwan, Canada, États-Unis, Allemagne, Espagne, Japon, Fédération Russe, Turquie, Royaume-Uni
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Ottawa Hospital Research InstituteInconnueDysfonctionnement des glandes de Meibomius | BléphariteCanada
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Janssen Research & Development, LLCComplétéHépatite BFrance, États-Unis, Belgique, Royaume-Uni, Pologne, Nouvelle-Zélande, Allemagne, Italie, Canada