A Study Designed to See How [14C]-CORT125134 is Taken up, Broken Down and Removed From the Body
7 août 2019 mis à jour par: Corcept Therapeutics
An Open-label, Single-dose Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Identification of Metabolite Structures for [14C]-CORT125134 in Healthy Subjects
The study was designed to evaluate how CORT125134 is taken up, broken down and removed from the body when given as an oral capsule to healthy subjects.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
The study was conducted to determine the recovery of [14C]-CORT125134 after the administration of a single oral dose of [14C]-CORT125134, to determine the routes and rate of elimination of [14C]-CORT125134 and associated radioactivity from the body, and to measure concentrations of radioactivity in the blood.
Additional objectives of the study were to determine the chemical structure of each significant metabolite in plasma, urine and feces.
Safety and tolerability were assessed.
Type d'étude
Interventionnel
Inscription (Réel)
9
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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Nottinghamshire
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Nottingham, Nottinghamshire, Royaume-Uni, NG11 6JS
- Quotient Clinical
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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
30 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Healthy males or healthy females of non-childbearing potential (surgically sterilized or postmenopausal [defined as a woman of with at least a 12 month history of amenorrhea with a follicle-stimulating hormone (FSH) >40 international units per liter (IU/L) in the absence of a reversible medical iatrogenic cause])
- Age 30 to 65 years of age
- A history of regular bowel movements (averaging ≥1 and ≤3 stools per day)
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent
- Male participants must agree to use an adequate method of contraception
- Participants are willing to abide by the study restrictions
Exclusion Criteria:
- Participation in a clinical research study within the previous 3 months
- Participants who have previously been enrolled in this study or participants who have previously been treated with CORT125134
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 milliliter (mL) of 40% spirit or a 125 mL glass of wine)
- Current smokers and those who have smoked within the last 12 months; this includes cigarettes, e-cigarettes and nicotine replacement products. A breath carbon monoxide reading of greater than 10 parts per million (ppm)
- Females of childbearing potential (female participants must have a negative urine pregnancy test)
- Male Participants with pregnant partners
- Radiation exposure exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. The measurement includes exposure from the present study, and diagnostic x rays and other medical exposures, but excludes background radiation. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999.
- Positive drugs of abuse test result
- Participants who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 grams per day paracetamol) or herbal remedies in the 14 days before study drug administration. Hormone replacement therapy is not permitted
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: Science basique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: [14C]-CORT125134
Two capsules each containing 125 milligrams (mg) [14C]-CORT125134 administered to each participant on 1 occasion
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Amount of radioactivity eliminated in urine
Délai: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
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Amount of radioactivity eliminated in feces
Délai: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
|
|
Amount of radioactivity eliminated in urine and feces
Délai: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
|
|
Cumulative amount of radioactivity eliminated in urine
Délai: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
|
|
Cumulative amount of radioactivity eliminated in feces
Délai: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
|
|
Cumulative amount of radioactivity eliminated in urine and feces
Délai: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
|
|
Pharmacokinetics (PK) of total radioactivity: lag time (tlag)
Délai: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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|
PK of total radioactivity: peak plasma concentration (Cmax)
Délai: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
|
|
PK of total radioactivity: time to reach maximum observed concentration (tmax)
Délai: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
|
|
PK of total radioactivity: area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast)
Délai: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
|
|
PK of total radioactivity: area under the plasma concentration-time curve from time zero to infinity (AUCinf)
Délai: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
|
|
PK of total radioactivity: area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCextrap)
Délai: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
|
|
PK of total radioactivity: 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 (lambda-z)
Délai: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
|
|
PK of total radioactivity: elimination half-life (t1/2)
Délai: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
|
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Metabolic profiling and structural identification in plasma, urine and feces
Délai: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Hematology
Délai: Screening, Day 1 pre-dose, Day 8
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Screening, Day 1 pre-dose, Day 8
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Clinical chemistry
Délai: Screening, Day 1 pre-dose, Day 8
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Screening, Day 1 pre-dose, Day 8
|
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Urinalysis
Délai: Screening, Day 1 pre-dose, Day 8
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Screening, Day 1 pre-dose, Day 8
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Blood pressure
Délai: Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
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Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
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Heart rate
Délai: Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
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Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
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Electrocardiogram
Délai: Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
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Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
|
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Percentage of subjects with adverse events
Délai: Screening to Day 28
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Screening to Day 28
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Physical examination
Délai: Screening and Day 8
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Screening and Day 8
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Tlag of CORT125134
Délai: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
|
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Cmax of CORT125134
Délai: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Tmax of CORT125134
Délai: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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AUClast of CORT125134
Délai: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
|
|
%AUCextrap of CORT125134
Délai: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
|
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AUCinf of CORT125134
Délai: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
|
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Lambda-z of CORT125134
Délai: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
|
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T1/2 of CORT125134
Délai: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Mean Residence Time (MRT) of CORT125134
Délai: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
|
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Apparent oral clearance (CL/F) of CORT125134
Délai: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
|
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Apparent volume of distribution (Vz/F) of CORT125134
Délai: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
|
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Number of metabolites >10% of circulating radioactivity in plasma
Délai: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
|
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Number of metabolites >10% of the dose in urine
Délai: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
|
|
Number of metabolites >10% of the dose in feces
Délai: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Pui Leung, MBChB, Quotient Clinical
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 août 2016
Achèvement primaire (Réel)
1 septembre 2016
Achèvement de l'étude (Réel)
1 septembre 2016
Dates d'inscription aux études
Première soumission
6 décembre 2016
Première soumission répondant aux critères de contrôle qualité
23 février 2017
Première publication (Réel)
1 mars 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
9 août 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
7 août 2019
Dernière vérification
1 août 2019
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- CORT125134-121
- 2016-000668-41 (Numéro EudraCT)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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 .