- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01975636
An Open-label, Single Dose Study to Determine the Metabolism and Elimination of [14C]E2609 in Healthy Male Subjects
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
A baseline (predose) fecal sample and a baseline (predose) urine sample will be obtained at the clinic prior to dosing on Day 1.
On Day 1, subjects will begin the Treatment Phase. Subjects will be released from the clinic after at least 10 days since dosing and as soon as the following conditions are met:
- greater than 90% of the administered radioactivity has been recovered, and
- less than 1% of the administered radioactive dose is recovered in two consecutive 24-hour samples each of urine and feces
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Wisconsin
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Madison, Wisconsin, États-Unis, 53704
- Covance Clinical Research Unit Inc.
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Madison, Wisconsin, États-Unis, 53704
- Covance Laboratories
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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
Subjects must meet criteria to be included in this study, including but not limited to the following:
- Healthy male 18 - 55 years, inclusive, at the time of informed consent
- Body mass index (BMI) of 18 to 32 kg/m2 at Screening
- Subjects must have had a successful vasectomy (confirmed azoospermia) or they and their female partners not be of childbearing potential or must be practicing highly effective contraception throughout the study period and for 30 days after study drug discontinuation. Sperm donation is not allowed during the study period and for 30 days after study drug discontinuation.
- Provide written informed consent
- Willing and able to comply with all aspects of the protocol
Exclusion Criteria
Subjects who meet any of the following criteria will be excluded from this study:
- Have participated in a 14C-research study within the 6 months prior to Day -2. The total exposure from this and any previous study must be within the recommended levels considered safe.
- Exposure to clinically significant radiation within 12 months prior to Day -2.
- Any laboratory abnormalities considered clinically significant by the investigator, which may require further investigations or treatment
- Clinically significant illness which required medical treatment within 8 weeks or a clinically significant infection within 4 weeks of dosing
- Any history of gastrointestinal surgery (e.g., hepatectomy, nephrotomy, digestive organ resection) that may affect PK profiles of study drugs
- Hypersensitivity to the study drugs or any of their excipients
- Known to be human immunodeficiency virus (HIV) positive
Restrictions will apply on prior and concomitant medications, food and beverages
Plan d'étude
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: E2609
Single oral 100 mg +/- 10 mg E2609 with a level of radioactive exposure consistent with the Radioactive Drug Research Committee allowance
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Single oral 100 mg +/- 10 mg E2609 with a level of radioactive exposure consistent with the Radioactive Drug Research Committee allowance
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Pharmacokinetics: Elimination of E2609: urine/feces concentration
Délai: Predose and every 24 hours postdose up to 28 days
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Total radioactivity will be analyzed in urine and feces predose and up to 28 days postdose.
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Predose and every 24 hours postdose up to 28 days
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Pharmacokinetics: Plasma concentration of E2609/metabolite
Délai: Predose andup to 648 hours postdose
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Total radioactivity will be analyzed in whole blood, plasma, and red blood cells.
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Predose andup to 648 hours postdose
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Pharmacokinetics: Metabolic profile of E2609: plasma/urine/feces concentration
Délai: Predose andup to 648 hours postdose
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Metabolite profiling in plasma, urine, and feces will be performed by liquid chromatography with radiodetection (radio-high performance liquid chromatography [HPLC]) methods.
A scintillation counter and/or AMS will be used to detect radioactivity.
If needed, plasma and feces samples will be treated with cysteine and/or other reagents before radio-HPLC analyses.
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Predose andup to 648 hours postdose
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- E2609-A001-005
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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