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- Essai clinique NCT02821858
Study to Investigate the Pharmacokinetics, Safety and Tolerability of Odalasvir and AL-335 in Healthy Japanese Participants
28 mars 2018 mis à jour par: Janssen Research & Development, LLC
A Phase 1, Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of Odalasvir and AL-335 in Healthy Japanese Subjects
The purpose of this study is to investigate the pharmacokinetics (PK), safety and tolerability following single oral administration of ascending doses of odalasvir (ODV) in healthy Japanese participants (Panel 1) and to investigate the PK, safety and tolerability following single oral administration of ascending doses of AL-335 in healthy Japanese participants (Panel 2; Sequential Design).
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
40
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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Surrey, Royaume-Uni
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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
20 ans à 55 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Participant must be a Japanese participant who has resided outside Japan for no more than 5 years and whose parents and grandparents are Japanese as determined by participant's verbal report
- Participant must have a body mass index (BMI: weight in kilogram [kg] divided by the square of height in meters) of 18.0 to 30.0 kilogram per meter square (kg/m^2), extremes included and a body weight not less than 50.0 kilogram (kg)
- Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at Screening. If there are abnormalities, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the Investigator
- Participant must have a blood pressure (after the participant supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted
- Female participant must agree to not donate eggs (ova, oocytes) for the purpose of assisted reproduction during the study and for a period of 60 days (Panel 1) or 30 days (Panel 2) after study drug administration or until the last follow-up visit, whichever occurs later
Exclusion Criteria:
- Participant has a history of liver or renal insufficiency (estimated creatinine clearance below 80 milliliters per minute [mL/min]); significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the Investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic or metabolic disturbances
- Participant has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Participant with a past history of heart arrhythmias (for example, extra systolic beats or tachycardia at rest); risk factors associated with Torsade de Pointes such as hypokalemia or family history of short/long QT syndrome or sudden unexplained death (including sudden infant death syndrome) in a first-degree relative [for example, sibling, offspring, or biological parent])
- Participant with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
- Participant has known allergies, hypersensitivity, or intolerance to odalasvir (ODV) or AL-335 or its excipients
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: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Panel 1: Treatment A
Participants will receive odalasvir (ODV) 50 milligram (mg) (n=8) or placebo (n=2) on Day 1.
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Un placebo correspondant sera administré.
ODV 50 mg (1 tablet) in Treatment A, 100 mg (2 tablets of 50 mg) in Treatment B and 300 mg (6 tablets of 50 mg) in Treatment C.
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Expérimental: Panel 1: Treatment B
Participants will receive ODV 100 mg (n=8) or placebo (n=2) on Day 1.
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Un placebo correspondant sera administré.
ODV 50 mg (1 tablet) in Treatment A, 100 mg (2 tablets of 50 mg) in Treatment B and 300 mg (6 tablets of 50 mg) in Treatment C.
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Expérimental: Panel 1: Treatment C
Participants will receive ODV 300 mg (n=8) or placebo (n=2) on Day 1.
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Un placebo correspondant sera administré.
ODV 50 mg (1 tablet) in Treatment A, 100 mg (2 tablets of 50 mg) in Treatment B and 300 mg (6 tablets of 50 mg) in Treatment C.
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Expérimental: Panel 2: Treatment D
Participants will receive AL-335 400 mg (n=8) or placebo (n=2) on Day 1 of Period 1.
Each treatment period will be separated by a washout period of 7 days.
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Un placebo correspondant sera administré.
AL-335 400 mg (1 tablet) in Treatment D, 800 mg (2 tablets of 400 mg) in Treatment E and 1200 mg (3 tablets of 400 mg) in Treatment F.
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Expérimental: Panel 2: Treatment E
Participants will receive AL-335 800 mg (n=8) or placebo (n=2) on Day 1 of Period 2. Each treatment period will be separated by a washout period of 7 days.
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Un placebo correspondant sera administré.
AL-335 400 mg (1 tablet) in Treatment D, 800 mg (2 tablets of 400 mg) in Treatment E and 1200 mg (3 tablets of 400 mg) in Treatment F.
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Expérimental: Panel 2: Treatment F
Participants will receive AL-335 1,200 mg (n=8) or placebo (n=2) on Day 1 of Period 3.
Each treatment period will be separated by a washout period of 7 days.
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Un placebo correspondant sera administré.
AL-335 400 mg (1 tablet) in Treatment D, 800 mg (2 tablets of 400 mg) in Treatment E and 1200 mg (3 tablets of 400 mg) in Treatment F.
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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 Concentration (Cmax) of Odalasvir (ODV)
Délai: From Day 1 to Day 14 after intake of ODV
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The Cmax is the maximum observed analyte concentration.
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From Day 1 to Day 14 after intake of ODV
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Time to Reach Maximum Observed Concentration (Tmax) of ODV
Délai: From Day 1 to Day 14 after intake of ODV
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The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
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From Day 1 to Day 14 after intake of ODV
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Area Under the Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of ODV
Délai: From Day 1 to Day 50-55 after intake of ODV
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The (AUC [0-last]) is the area under the analyte concentration-time curve from time 0 to time of the last quantifiable concentration.
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From Day 1 to Day 50-55 after intake of ODV
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Elimination Rate Constant (Lambda[z]) of ODV
Délai: From Day 1 to Day 50-55 after intake of ODV
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Lambda(z) is first order elimination 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.
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From Day 1 to Day 50-55 after intake of ODV
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Elimination Half-Life (t1/2) of ODV
Délai: From Day 1 to Day 50-55 after intake of ODV
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Elimination half-life (t[1/2]) is associated with the terminal slope (lambda [z]) of the semi-logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
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From Day 1 to Day 50-55 after intake of ODV
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Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of ODV
Délai: From Day 1 to Day 50-55 after intake of ODV
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The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
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From Day 1 to Day 50-55 after intake of ODV
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Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability for ODV
Délai: Up to 50-55 days after intake of ODV
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Up to 50-55 days after intake of ODV
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Maximum Observed Concentration (Cmax) of AL-335
Délai: From Day 1 to Day 4 after intake of AL-335
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The Cmax is the maximum observed analyte concentration.
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From Day 1 to Day 4 after intake of AL-335
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Time to Reach Maximum Observed Concentration (Tmax) of AL-335
Délai: From Day 1 to Day 4 after intake of AL-335
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The Tmax is defined as actual sampling time to reach maximum observed concentration.
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From Day 1 to Day 4 after intake of AL-335
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Area Under the Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of AL-335
Délai: From Day 1 to Day 4 after intake of AL-335
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The (AUC [0-last]) is the area under the concentration-time curve from time 0 to time of the last quantifiable concentration.
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From Day 1 to Day 4 after intake of AL-335
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Elimination Rate Constant (Lambda[z]) of AL-335
Délai: From Day 1 to Day 4 after intake of AL-335
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Lambda(z) is first order elimination 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.
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From Day 1 to Day 4 after intake of AL-335
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Elimination Half-Life (t1/2) of AL-335
Délai: From Day 1 to Day 4 after intake of AL-335
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Elimination half-life (t[1/2]) is associated with the terminal slope (lambda [z]) of the semi-logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
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From Day 1 to Day 4 after intake of AL-335
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Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of AL-335
Délai: From Day 1 to Day 4 after intake of AL-335
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The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
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From Day 1 to Day 4 after intake of AL-335
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Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability for AL-335
Délai: Up to 30 to 35 days after last intake of AL-335
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Up to 30 to 35 days after last intake of AL-335
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Janssen Research and Developement, LLC Clinical Trial, Janssen Research and Developement, LLC
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)
14 juin 2016
Achèvement primaire (Réel)
9 septembre 2016
Achèvement de l'étude (Réel)
30 septembre 2016
Dates d'inscription aux études
Première soumission
10 juin 2016
Première soumission répondant aux critères de contrôle qualité
29 juin 2016
Première publication (Estimation)
4 juillet 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
29 mars 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
28 mars 2018
Dernière vérification
1 mars 2018
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CR108178
- 64294178HPC1005 (Autre identifiant: Janssen Research & Development, LLC)
- 2015-005639-42 (Numéro EudraCT)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique 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 .