A Study to Assess Bioavailability & Food Effect of Different Liquid and Capsule Formulations of TMC435.
24 juin 2013 mis à jour par: Janssen R&D Ireland
A Phase I, Open-Label, Randomized, 3-Panel, 3-way Crossover Trial in Healthy Adult Subjects to Assess the Relative Bioavailability of TMC435 Following Administration of 2 Liquid Formulations or 2 Different Capsule Concept Formulations Compared ot the Phase III 150 mg Capsule, and to Assess the Effect of Food on the Bioavailability of TMC435 Following Administration of the Liquid Formulations.
The purpose of this study is to evaluate the relative bioavailability and the short-term safety and tolerability of TMC435 following administration of 3 single oral doses of 150 mg, given as different formulations in healthy adult participants.
In addition, this study is to assess for the acceptability of the taste of both liquid formulations.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
TMC435 is being investigated for the treatment of chronic hepatitis C infection.
The current study is a Phase I, open-label (both participant and investigator know the name of the medication given at certain moment), randomized (study medication is assigned by chance) study designed to assess the relative bioavailability and food effect of 2 liquid formulations of TMC435, currently being developed for potential pediatric use, compared to the Phase III 150 mg capsule.
Also new capsule concept formulations will be investigated in comparison with the Phase III 150 mg capsule.
The study will be performed in healthy adult participants and is divided over 3 panels.
Participants will be randomized within a panel.
Each participant will receive 3 different treatments according to a classical 6-sequence, 3-period Williams design.
In Panel 1 and Panel 2, a single oral dose of 150 mg TMC435 oral suspension respectively with other strength will be compared with the capsule used in Phase III.
In Panel 3, two different capsule concept formulations will be compared with the capsule used in Phase III.
In panels containing the liquids, formulations will be compared under fasted and fed conditions to investigate the food effect.
In all treatments, the participants will receive medication on Day 1 of each treatment.
There will be a washout period of at least 7 days between subsequent treatments.
The main focus of the trial is the pharmacokinetic characteristics of all formulations (level-profile of TMC435 over time in the blood stream).
This evaluation requires multiple blood samples from Day 1 till Day 4 in each treatment.
Safety assessments (blood and urine tests, blood pressure, pulse, electrocardiogram, and physical examination) will follow a different schedule and will be evaluated from signing of the Informed Consent Form onwards until the last trial-related visit throughout the study.
Type d'étude
Interventionnel
Inscription (Réel)
72
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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Harrow, 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
18 ans à 55 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Healthy volunteers should be healthy on the basis of physical examination, medical history, laboratory tests, 12-lead electrocardiogram and vital signs, performed at screening, have a body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included and be non-smoking for at least 3 months prior to screening.
- Women must be postmenopausal for at least 2 years and/or surgically sterile or not heterosexually active for duration of the trial.
Exclusion Criteria:
- All participants with known allergies, hypersensitivity or intolerance to TMC435 or any of the excipients.
- Use of concomitant medication, including over the counter products, herbal medication and dietary supplements, except for paracetamol (acetaminophen) or ibuprofen.
- Any condition that, in the opinion of the investigator, would compromise the study or well-being of the participant or prevent the subject from meeting or performing study requirements.
- History or suspicion of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in investigator's opinion would compromise participant's safety and/or compliance with the trial procedures.
- Participation in an investigational drug trial with TMC435.
- Infected with HIV or Hepatitic A, B or C.
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 croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Treatment A
Panel 1: single oral dose of 150 mg TMC435 150 mg capsule, fed
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single oral dose of 150 mg TMC435 150 mg capsule
Autres noms:
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Expérimental: Treatment B
Panel 1: single oral dose of 150 mg TMC435 oral suspension (20 mg/mL), fasted
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single oral dose of 150 mg TMC435 oral suspension
Autres noms:
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Expérimental: Treatment C
Panel 1: single oral dose of 150 mg TMC435 oral suspension (20 mg/mL), fed
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single oral dose of 150 mg TMC435 oral suspension
Autres noms:
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Expérimental: Treatment D
Panel 2: single oral dose of 150 mg TMC435 150 mg capsule, fed
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single oral dose of 150 mg TMC435 150 mg capsule
Autres noms:
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Expérimental: Treatment E
Panel 2: single oral dose of 150 mg TMC435 oral solution (10 mg/mL), fasted
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single oral dose of 150 mg TMC435 oral solution
Autres noms:
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Expérimental: Treatment F
Panel 2: single oral dose of 150 mg TMC435 oral solution (10 mg/mL), fed
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single oral dose of 150 mg TMC435 oral solution
Autres noms:
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Expérimental: Treatment G
Panel 3: single oral dose of 150 mg TMC435 150 mg capsule, fed
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single oral dose of 150 mg TMC435 150 mg capsule
Autres noms:
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Expérimental: Treatment H
Panel 3: single oral dose of 150 mg TMC435 capsule concept K, fed
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single oral dose of 150 mg TMC435 capsule concept K
Autres noms:
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Expérimental: Treatment I
Panel 3: single oral dose of 150 mg TMC435 capsule concept L, fed
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single oral dose of 150 mg TMC435 capsule concept L
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Comparing the bioavailability of oral solution and oral suspension formulation with the capsule formulation of TMC435 (fed state)
Délai: 4 days
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Comparing the rate and extent of absorption (bioavailability) of 2 different liquid formulations (oral suspension [150 mg ie, 20 mg/mL] and oral solution [150 mg ie, 10 mg/mL]) versus capsule formulation (150 mg) of TMC435, after a high-fat breakfast (fed state)
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4 days
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Comparing the bioavailability of oral solution and oral suspension formulation of TMC435 in fed and fasted state
Délai: 4 days
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Comparing the rate and extent of absorption (bioavailability) of 2 different liquid formulations (oral suspension [150 mg ie, 20 mg/mL] and oral solution [150 mg ie, 10 mg/mL]) of TMC435 in fed state (high-fat breakfast) versus fasted state
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4 days
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Comparing the bioavailability of concept K capsule and concept L capsule formulation with the capsule formulation of TMC435 (fed state)
Délai: 4 days
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Comparing the rate and extent of absorption (bioavailability) of 2 different capsule formulations (concept K capsule [150 mg] and concept L capsule [150 mg]) versus capsule formulation (150 mg) of TMC435 after a high-fat breakfast (fed state)
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4 days
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of participants with adverse events
Délai: 18 days
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Adverse events, abnormal clinical laboratory findings, abnormalities assessed in vital signs examination, physical examination, ECG measurements were evaluated for safety and tolerability during the study
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18 days
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Acceptability of taste assessed by taste questionnaires
Délai: Day 1 of Treatment B and E
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Taste Questionnaires used to assess taste acceptability of oral suspension and solution of TMC435 under fasted conditions.
Taste Questionnaire for adults: participant had to select appropriate choice (None, Weak, Moderate, Strong) for 3 different types of tastes "Sweetness, Bitterness, Flavour" and also select appropriate choice (Bad, Amost acceptable, Acceptable and Good) for the Overall taste.
For pediatric participants: fill the visual analog scale by selecting appropriate choice (Dislike it very much, Dislike it a little, Not sure, Like it a little and Like it very much)
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Day 1 of Treatment B and E
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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
1 mars 2012
Achèvement primaire (Réel)
1 mai 2012
Achèvement de l'étude (Réel)
1 mai 2012
Dates d'inscription aux études
Première soumission
23 janvier 2012
Première soumission répondant aux critères de contrôle qualité
3 avril 2012
Première publication (Estimation)
5 avril 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
25 juin 2013
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 juin 2013
Dernière vérification
1 juin 2013
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CR100787
- TMC435HPC1002 (Autre identifiant: Janssen R&D Ireland)
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