- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01430078
A Study to Assess the Bioavailability of ASP015K
A Phase 1, Open-Label, 4-Way Crossover Regional Drug Absorption Study to Assess the Bioavailability of ASP015K in Healthy Subjects
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Each subject will participate in four separate study periods. In each period, subjects will be admitted to the clinical unit approximately seven hours on the day prior to being given study drug. Subjects will remain at the clinical research unit for the next 24 hours after they have received study drug. Subjects will return to the clinical research unit at 36 and 48 hours after they have received study drug to give blood samples. There will be a minimum of a four day "washout" period, between each study period.
Under certain circumstances, subjects may be asked to return to the clinical research unit for an additional study period.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
-
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Nottingham
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Ruddington, Nottingham, Royaume-Uni, NG116JS
- Quotient Clinical Limited
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Subject weighing at least 45 kg and BMI of 18-32 kg/m2
- Subject must demonstrate their ability to swallow an empty size 000 capsule
- Subject agrees to sexual abstinence, is surgically sterile (with documentation provided by a healthcare professional), or is using a medically acceptable method to prevent pregnancy during the study
- Subject has a normal 12-lead ECG
- Subject is medically healthy, with no clinically significant medical history or abnormalities
Exclusion Criteria:
- Subject has ever sought advice from, or been referred to, a General Practitioner (GP) or counselor for abuse or misuse of alcohol, non medical drugs, medicinal drugs or other substance abuse e.g. solvents
- Subject is currently using or has had previous use of Class A drugs such as opiates, cocaine, ecstasy, lysergic acid diethylamide (LSD) and intravenous amphetamines
- The subject has a positive drugs of abuse test result
- The subject regularly consumes alcohol >21 units per week
- The subject is a current smoker or has smoked within the last 12 months
- The subject has clinically significant abnormal biochemistry, hematology or urinalysis
- The subject has a history of gastrointestinal surgery (with the exception of appendectomy unless it was performed within the previous 12 months)
- The subject has a history of clinically significant cardiovascular, renal, hepatic, respiratory and particularly gastrointestinal disease, especially peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's Disease or Irritable Bowel Syndrome
- The subject has had radiation exposure from clinical trials exceeding 5 mSv in the last twelve months or 10 mSv in the last five years
- The subject has a history of adverse reaction or allergy to study drug or its excipients The subject suffers from hayfever they must not have or be expecting to have symptoms during the study
- The subject has had acute diarrhoea or constipation in the 7 days before the first study day
- The subject has the presence of non-removable metal objects such as metal plates, screws, etc, in the abdominal region of the body (with the exception of sterilisation clips)
- The subject has a positive Hepatitis B virus (HBV), Hepatitis C virus (HCV) or Human Immunodeficiency virus HIV results
- The subject has had treatment with prescription drugs or complementary and alternative medicines within 14 days prior to study drug administration, or over the counter medication within 7 days prior to study drug administration
- The subject has/had a symptomatic, viral, bacterial, or fungal infection within 1 week prior to clinic check in
- The subject has been vaccinated within the last 90 days
- The subject has participated in a clinical research study involving investigational drugs or dosage forms within the previous 90 days
- The subject has had any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 90 days or donated plasma within 7 days prior to clinic admission
- The subject has a past history of tuberculosis or absence of evidence of successful TB immunization as assessed at clinical examination of the Bacille Calmette-Guérin (BCG) scar
- The subject has a past history of recurrent herpes simplex or varicella zoster infections
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Regimen A
ASP015K oral tablet
|
oral tablet
solution via oral capsule
|
Expérimental: Regimen B
ASP015K solution delivered to distal small bowel via oral capsule
|
oral tablet
solution via oral capsule
|
Expérimental: Regimen C
ASP015K solution delivered to ascending colon via oral capsule
|
oral tablet
solution via oral capsule
|
Expérimental: Regimen D
ASP015K solution delivered to distal transverse colon via oral capsule
|
oral tablet
solution via oral capsule
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Pharmacokinetic assessment of AUC through the analysis of blood samples
Délai: Up to 45 days
|
Up to 45 days
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Pharmacokinetic assessment of maximum concentration (Cmax) through the analysis of blood samples
Délai: Up to 45 days
|
Up to 45 days
|
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 015K-CL-PK15
- 2010-021160-15 (Numéro EudraCT)
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 .
Essais cliniques sur En bonne santé
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AstraZenecaParexelComplété
Essais cliniques sur ASP015K
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Astellas Pharma Global Development, Inc.ComplétéVolontaires en bonne santé | Pharmacocinétique de ASP015K | Effet alimentaireÉtats-Unis
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Astellas Pharma IncComplétéArthrite, rhumatoïdeJapon, Corée, République de, Taïwan
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