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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

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

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
Expérimental: Panel 1: Treatment A
Participants will receive odalasvir (ODV) 50 milligram (mg) (n=8) or placebo (n=2) on Day 1.
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.
Expérimental: Panel 1: Treatment B
Participants will receive ODV 100 mg (n=8) or placebo (n=2) on Day 1.
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.
Expérimental: Panel 1: Treatment C
Participants will receive ODV 300 mg (n=8) or placebo (n=2) on Day 1.
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.
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.
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.
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.
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.
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.
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Maximum Observed Concentration (Cmax) of Odalasvir (ODV)
Délai: From Day 1 to Day 14 after intake of ODV
The Cmax is the maximum observed analyte concentration.
From Day 1 to Day 14 after intake of ODV
Time to Reach Maximum Observed Concentration (Tmax) of ODV
Délai: From Day 1 to Day 14 after intake of ODV
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
From Day 1 to Day 14 after intake of ODV
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
The (AUC [0-last]) is the area under the analyte concentration-time curve from time 0 to time of the last quantifiable concentration.
From Day 1 to Day 50-55 after intake of ODV
Elimination Rate Constant (Lambda[z]) of ODV
Délai: From Day 1 to Day 50-55 after intake of ODV
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.
From Day 1 to Day 50-55 after intake of ODV
Elimination Half-Life (t1/2) of ODV
Délai: From Day 1 to Day 50-55 after intake of ODV
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).
From Day 1 to Day 50-55 after intake of ODV
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
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.
From Day 1 to Day 50-55 after intake of ODV
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
Up to 50-55 days after intake of ODV
Maximum Observed Concentration (Cmax) of AL-335
Délai: From Day 1 to Day 4 after intake of AL-335
The Cmax is the maximum observed analyte concentration.
From Day 1 to Day 4 after intake of AL-335
Time to Reach Maximum Observed Concentration (Tmax) of AL-335
Délai: From Day 1 to Day 4 after intake of AL-335
The Tmax is defined as actual sampling time to reach maximum observed concentration.
From Day 1 to Day 4 after intake of AL-335
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
The (AUC [0-last]) is the area under the concentration-time curve from time 0 to time of the last quantifiable concentration.
From Day 1 to Day 4 after intake of AL-335
Elimination Rate Constant (Lambda[z]) of AL-335
Délai: From Day 1 to Day 4 after intake of AL-335
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.
From Day 1 to Day 4 after intake of AL-335
Elimination Half-Life (t1/2) of AL-335
Délai: From Day 1 to Day 4 after intake of AL-335
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).
From Day 1 to Day 4 after intake of AL-335
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
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.
From Day 1 to Day 4 after intake of AL-335
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
Up to 30 to 35 days after last intake of AL-335

Collaborateurs et enquêteurs

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

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

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