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A Study to Investigate the Potential Interaction Between Telaprevir and Methadone, at Steady-State

30 novembre 2012 mis à jour par: Tibotec BVBA

A Phase I, Open-Label, Single-Sequence Drug-Drug Interaction Trial in Subjects on Stable Methadone Maintenance Therapy, to Investigate the Potential Interaction Between Telaprevir 750 mg q8h and Methadone, at Steady-State

The purpose of this study is to evaluate the effect of steady-state (constant concentration of medication in the blood) telaprevir 750 mg every 8 hours on the steady-state pharmacokinetics (how the drug concentrations change over time) of R- and S-methadone.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

This is a Phase 1, open-label (all people know the identity of the intervention), single-sequence study to evaluate the potential interaction of steady-state telaprevir on the steady-state pharmacokinetics of methadone. The study consists of 3 phases: the screening phase (within 21 days prior to the start of supervised methadone intake on Day -14), treatment phase, and follow-up phase. Participants on stable methadone maintenance therapy will be enrolled in this study and their methadone doses will not be changed starting at Day -14. During the treatment phase, telaprevir will be added for 7 days (from Day 1 to Day 7) to participants' current methadone therapy. The methadone dosage will not to be changed from Day -14 until Day 7. All the intakes of methadone and telaprevir will be supervised and pharmacokinetic parameters will be measured during the study. Safety evaluations for adverse events, clinical laboratory tests, alcohol breath test, cardiovascular safety, and other evaluations (physical examination, and pharmacodynamic assessments) will be performed throughout the study. The total duration of the study for each participant is approximately 60 days.

Type d'étude

Interventionnel

Inscription (Réel)

18

Phase

  • La phase 1

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:

  • Must receive once daily oral methadone maintenance therapy at a stable individualized dose of 30 to 130 mg for at least 2 weeks prior to screening, formulated as commercially available tablets or solution
  • Must agree not to change the current methadone dose from screening until Day 7 included to have a daily observed and documented methadone intake from Day -14 until Day 8 and a daily observed and documented telaprevir intake from Day 1 until Day 7
  • Participants have to obtain approval for participation from his/her addiction physician, and the addiction physician has to agree to provide medical care for the participant after discharge from study center
  • General medical condition must not interfere with the assessments and the completion of the study
  • Health assessments will be done on the basis of physical examination, medical history, electrocardiogram, vital signs and the results of blood biochemistry, blood coagulation and hematology tests and a urinalysis carried out at screening

Exclusion Criteria:

  • History of any illness that could confound the results of the study or pose an additional risk in administering study medication to the participant, for eg, history of relevant medication or food allergies, history of cardiovascular or central nervous system disease, history or presence of clinically significant pathology or history of mental disease
  • Consumption of herbal medications or dietary supplements, vitamins, and grapefruit or grapefruit juice, apple juice or orange juice within 14 days before Day -1
  • Current alcohol use, which, in the assessment of the investigator, could compromise participant's safety or compliance with the study protocol procedures
  • Test positive for drugs of abuse such as cocaine, amphetamines, barbiturates, benzodiazepines, or opiates on Day -2 unless explained by allowed concomitant medications
  • Participation in a clinical study involving administration of an investigational medication within 60 days or 5 half-lives (whichever was longer) prior to the screening visit

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: Telaprevir + Methadone
Patients will receive telaprevir 750 mg orally, every 8 hours from Day 1 to Day 7, along with methadone 30 to 130 mg, once daily.
Médicament: Telaprevir
Telaprevir 750 mg will be administered orally, every 8 hours from Day 1 to Day 7, along with methadone, once daily.
Médicament: Methadone
Methadone 30 to 130 mg will be administered as a stable oral therapy from Day -14 to Day -1, in combination with telaprevir from Day 1 to Day 7, and then alone as a continued intake dose for an additional 30 to 32 days.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Maximum plasma concentration (Cmax) of telaprevir
Délai: On Day 7
Pharmacokinetic parameter Cmax of telaprevir is measured when telaprevir will be administered at 750 mg every 8 hours for 7 days added to stable methadone maintenance therapy.
On Day 7
Minimum plasma concentration (Cmin) of telaprevir
Délai: On Day 7
Pharmacokinetic parameter Cmin of telaprevir is measured when telaprevir will be administered every 8 hours for 7 days added to stable methadone maintenance therapy.
On Day 7
Area under the plasma concentration-time curve (AUC) of telaprevir
Délai: On Day 7
Pharmacokinetic parameter AUC of telaprevir is measured when telaprevir will be administered every 8 hours for 7 days added to stable methadone maintenance therapy.
On Day 7
Cmax of R-methadone
Délai: Day -1 and Day 7
Pharmacokinetic parameter Cmax of R-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir at 750 mg every 8 hours.
Day -1 and Day 7
Cmin of R-methadone
Délai: Day -1 and Day 7
Pharmacokinetic parameter Cmin of R-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir every 8 hours.
Day -1 and Day 7
AUC of R-methadone
Délai: Day -1 and Day 7
Pharmacokinetic parameter AUC of R-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir every 8 hours.
Day -1 and Day 7
Cmax of S-methadone
Délai: Day -1 and Day 7
Pharmacokinetic parameter Cmax of S-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir at 750 mg every 8 hours.
Day -1 and Day 7
Cmin of S-methadone
Délai: Day -1 and Day 7
Pharmacokinetic parameter Cmin of S-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir every 8 hours.
Day -1 and Day 7
AUC of S-methadone
Délai: Day -1 and Day 7
Pharmacokinetic parameter AUC of S-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir every 8 hours.
Day -1 and Day 7

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Short Opiate Withdrawal Scale [SOWS]
Délai: Day -7, and Day -2 to Day 7
Pharmacodynamic assessments of methadone withdrawal are performed by means of SOWS.
Day -7, and Day -2 to Day 7
Desires for Drugs Questionnaire [DDQ]
Délai: Day -7, and Day -2 to Day 7
Pharmacodynamic assessments of methadone withdrawal are performed by means of DDQ.
Day -7, and Day -2 to Day 7
Pupillometry
Délai: Day -1, Day 2, Day 4, and Day 7
Pharmacodynamic assessments of methadone withdrawal are performed by means of pupillometry.
Day -1, Day 2, Day 4, and Day 7
Number of participants with adverse events
Délai: Up to 60 days
Up to 60 days

Collaborateurs et enquêteurs

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

Parrainer

Tibotec BVBA

Collaborateurs

Vertex Pharmaceuticals Incorporated

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.

Publications générales

Liens utiles

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 juillet 2009

Achèvement primaire (Réel)

1 novembre 2009

Achèvement de l'étude (Réel)

1 décembre 2009

Dates d'inscription aux études

Première soumission

2 juillet 2009

Première soumission répondant aux critères de contrôle qualité

2 juillet 2009

Première publication (Estimation)

7 juillet 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

3 décembre 2012

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 novembre 2012

Dernière vérification

1 novembre 2012

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CR015931
  • VX-950-TiDP24-C135 (Autre identifiant: Tibotec-Virco Virology BVBA)

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 .

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