- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02292433
A Phase 1 Study In Japanese Subjects With Type 2 Diabetes Mellitus As Monotherapy
16 février 2016 mis à jour par: Pfizer
A Phase 1, Randomized, Double-blind, Placebo-controlled, 3- Period, Crossover Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Two Dose Levels of Pf-04937319 In Japanese Subjects With Type 2 Diabetes Mellitus as Monotherapy
Study B1621018 will assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Two Dose Levels of Pf-04937319 in Japanese Subjects with Type 2 Diabetes Mellitus As Monotherapy
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
12
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
-
-
Tokyo
-
Hachioji-shi, Tokyo, Japon, 192-0071
- P-one clinic, Keikokai medical corporation
-
-
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
20 ans à 64 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Patients with type 2 diabetes, on diet/exercise therapy only or background therapy with 1 oral anti-diabetic agent (excluding Actos)
Exclusion Criteria:
- Patients with cardiovascular event
- Patients with diabetic complications
- Female subjects who are pregnant or planning to become pregnant
- Subjects with unstable medical conditions (eg, hypertension)
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: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: PF-04937319
PF-04937319 Split dose
|
tablets, 150 mg with breakfast plus 100 mg with lunch, 7 days
tablets, 50 mg with breakfast plus 50 mg with lunch, 7 days
|
Comparateur placebo: Placebo
Placebo split dose
|
tablets, breakfast plus lunch, 7 days
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Number of Participants With Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Délai: Baseline up to 14 days after the last dose of study drug (minimum 8 weeks to maximum of 17 weeks)
|
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
|
Baseline up to 14 days after the last dose of study drug (minimum 8 weeks to maximum of 17 weeks)
|
Number of Participants With Protocol Defined Hypoglycaemic Adverse Events (HAEs)
Délai: Baseline up to 14 days after the last dose of study drug (minimum 8 weeks to maximum of 17 weeks)
|
A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels.
HAE was defined as 1 of the given definitions: 1) Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; 2) Characteristic symptoms of HAE with home glucose monitoring measurement of less than or equal to (=<) 70 milligram per deciliter (mg/dL) using sponsor-provided, plasma-referenced, home glucometers (or central laboratory); 3) any glucose value =<49 mg/dL using sponsor-provided, plasma-referenced, home glucometers (or central laboratory) with or without accompanying symptoms.
|
Baseline up to 14 days after the last dose of study drug (minimum 8 weeks to maximum of 17 weeks)
|
Maximum Observed Plasma Concentration (Cmax) on Day 1 for PF-04937319
Délai: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
|
0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 for PF-04937319
Délai: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
|
0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
|
|
Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 1 for PF-04937319
Délai: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post-dose on Day 1
|
AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).
|
0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post-dose on Day 1
|
Maximum Observed Plasma Concentration (Cmax) on Day 7 for PF-04937319
Délai: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
|
0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 7 for PF-04937319
Délai: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
|
0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
|
|
Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 7 for PF-04937319
Délai: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
|
AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).
|
0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
|
Pre-dose Plasma Concentration (Ctrough) on Day 7 for PF-04937319
Délai: 0 hour (pre-dose) on Day 7
|
Ctrough is the concentration prior to study drug administration.
|
0 hour (pre-dose) on Day 7
|
Average Plasma Concentration (Cav) on Day 7 for PF-04937319
Délai: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
|
Cav is the average plasma concentration during the 0 to 24 hour time period.
|
0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
|
Apparent Oral Clearance on Day 7 for PF-04937319
Délai: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
|
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Clearance obtained after oral dose (apparent oral clearance) is influenced by the oral bioavailability.
It is calculated as the total oral daily dose divided by AUC24, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours.
|
0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
|
Terminal Half-Life (t1/2) on Day 7 for PF-04937319
Délai: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
|
Terminal half-life is the time measured for the plasma concentration to decrease by one half.
Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (*) 2/k el, where 'k el' is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Only those data points judged to describe the terminal log-linear decline were used in the regression.
|
0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
|
Apparent Volume of Distribution on Day 7 for PF-04937319
Délai: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
|
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Apparent volume of distribution after oral dose is influenced by the oral bioavailability.
It is calculated as the total oral daily dose divided by AUC24* k el, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours and terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
|
0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
|
Accumulation Ratio (Rac) on Day 7 for PF-04937319
Délai: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
|
Rac is based on AUC24.
It is the ratio of AUC24 of Day 7 and AUC24 of Day 1, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours.
|
0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Maximum Observed Plasma Concentration (Cmax) on Day 1 for PF-06455349
Délai: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
|
PF-06455349 is a metabolite of PF-04937319.
|
0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 for PF-06455349
Délai: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
|
PF-06455349 is a metabolite of PF-04937319.
|
0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
|
Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 1 for PF--06455349
Délai: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
|
AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).
PF-06455349 is a metabolite of PF-04937319.
|
0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
|
Metabolite to Parent Ratio for AUC24 (MRAUC24) on Day 1
Délai: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
|
MRAUC24 is the ratio of AUC24 of PF-06455349 (metabolite) to AUC24 of PF-04937319 (parent drug) * ratio of molecular weight of PF-04937319 to molecular weight of PF-06455349, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours.
|
0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
|
Maximum Observed Plasma Concentration (Cmax) on Day 7 for PF--06455349
Délai: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
|
PF-06455349 is a metabolite of PF-04937319.
|
0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 7 for PF-06455349
Délai: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
|
PF-06455349 is a metabolite of PF-04937319.
|
0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
|
Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 7 for PF--06455349
Délai: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
|
AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).
PF-06455349 is a metabolite of PF-04937319.
|
0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
|
Pre-dose Plasma Concentration (Ctrough) on Day 7 for PF--06455349
Délai: 0 hour (pre-dose) on Day 7
|
Ctrough is the concentration prior to study drug administration.
PF-06455349 is a metabolite of PF-04937319.
|
0 hour (pre-dose) on Day 7
|
Average Plasma Concentration (Cav) on Day 7 for PF--06455349
Délai: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
|
Cav is the average plasma concentration during the 0 to 24 hour time period.
PF-06455349 is a metabolite of PF-04937319.
|
0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
|
Terminal Half-Life (t1/2) on Day 7 for PF-06455349
Délai: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
|
Terminal half-life is the time measured for the plasma concentration to decrease by one half.
Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) * 2/k el, where 'k el' is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Only those data points judged to describe the terminal log-linear decline were used in the regression.
PF-06455349 is a metabolite of PF-04937319.
|
0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
|
Accumulation Ratio (Rac) on Day 7 for PF-06455349
Délai: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
|
Rac is based on AUC24.
It is the ratio of AUC24 of Day 7 and AUC24 of Day 1, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours.
PF-06455349 is a metabolite of PF-04937319.
|
0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
|
Metabolite to Parent Ratio for AUC24 (MRAUC24) on Day 7
Délai: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
|
MRAUC24 is the ratio of AUC24 of PF-06455349 (metabolite) to AUC24 of PF-04937319 (parent drug) * ratio of molecular weight of PF-04937319 to molecular weight of PF-06455349, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours.
PF-06455349 is a metabolite of PF-04937319.
|
0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
|
Change From Baseline in Weighted Mean Daily Glucose (WMDG) at Day 7
Délai: Pre-morning meal, 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16 and 20 hours post- morning meal on Day 0; pre-morning dose, 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20 hours post-morning dose on Day 7
|
WMDG was defined as time-weighted mean daily glucose.
WMDG was calculated by as the time-weighted mean of glucose levels at actual time points for glucose sampling, for Day 0 (Baseline) and Day 7.
|
Pre-morning meal, 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16 and 20 hours post- morning meal on Day 0; pre-morning dose, 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20 hours post-morning dose on Day 7
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Last Day of Treatment
Délai: Pre-morning meal on Day 0, pre-morning dose on Day 1, pre-morning dose on Day 7, pre-morning meal on Day 8
|
FPG was defined as plasma glucose measurements taken pre-breakfast, in the fasted state, and prior to dosing with study drug.
Baseline was defined as the average of Hour 0 measurements taken on Day 0 and Day 1 in each intervention period.
The measurement on the last day of treatment was defined as the average of Hour 0 measurements taken on Day 7 and Day 8 in each period.
|
Pre-morning meal on Day 0, pre-morning dose on Day 1, pre-morning dose on Day 7, pre-morning meal on Day 8
|
Change From Baseline in Pre-Meal Insulin at Day 7
Délai: Pre-morning meal (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) after morning meal on Day 0 (Baseline); pre-morning dose (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) post-morning dose on Day 7
|
Time-matched change from baseline in pre-meal serum insulin on Day 7 of each period was analyzed.
Pre-meal insulin levels therefore, pre-breakfast, pre-lunch, and pre-dinner were analyzed.
|
Pre-morning meal (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) after morning meal on Day 0 (Baseline); pre-morning dose (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) post-morning dose on Day 7
|
Change From Baseline in Pre-Meal C-Peptide at Day 7
Délai: Pre-morning meal (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) after morning meal on Day 0 (Baseline); pre-morning dose (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) post-morning dose on Day 7
|
Time-matched change from baseline in pre-meal serum C-peptide on Day 7 of each period was analyzed.
Pre-meal C-peptide levels therefore, pre-breakfast, pre-lunch, and pre-dinner were analyzed.
|
Pre-morning meal (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) after morning meal on Day 0 (Baseline); pre-morning dose (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) post-morning dose on Day 7
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
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.
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 janvier 2015
Achèvement primaire (Réel)
1 mars 2015
Achèvement de l'étude (Réel)
1 mars 2015
Dates d'inscription aux études
Première soumission
12 novembre 2014
Première soumission répondant aux critères de contrôle qualité
12 novembre 2014
Première publication (Estimation)
17 novembre 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
15 mars 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 février 2016
Dernière vérification
1 février 2016
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- B1621018
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 Diabète sucré de type 2
-
Bnai Zion Medical CenterInconnue
-
Jiangsu HengRui Medicine Co., Ltd.Complété
-
Asahi Kasei Pharma CorporationRecrutement
-
University of MinnesotaActif, ne recrute pasHypoglycémie | Diabète sucré de type 2États-Unis
-
University of Campania "Luigi Vanvitelli"ComplétéDiabète sucré de type 2Italie
-
University of LiverpoolAstraZeneca; Clinical Practice Research DatalinkActif, ne recrute pas
-
Regor Pharmaceuticals Inc.RésiliéDiabète sucré de type 2États-Unis
-
Charles Drew University of Medicine and ScienceNational Center for Research Resources (NCRR)Résilié
-
Population Health Research InstituteNovo Nordisk A/SComplétéDiabète sucré de type 2Canada
-
Northwell HealthPatient-Centered Outcomes Research InstituteComplétéDiabète sucré de type 2 | Diabète de type 2États-Unis
Essais cliniques sur PF-04937319 high dose
-
PfizerComplété
-
PfizerComplétéDiabète sucré, Type 2Taïwan, États-Unis, Hongrie, Canada, Slovaquie, Inde, Bulgarie
-
PfizerComplété
-
PfizerComplétéDiabète sucré de type 2États-Unis, Hongrie, Taïwan, Roumanie, Inde, Afrique du Sud, Philippines, Slovaquie
-
University of MinnesotaRecrutementGreffe d'organe solideÉtats-Unis
-
PfizerComplété
-
PfizerComplétéDiabète sucré, type 1États-Unis
-
PfizerComplétéParticipants en bonne santéÉtats-Unis, Belgique
-
Reistone Biopharma Company LimitedRésilié
-
PfizerComplétéPeladeChine, États-Unis, Espagne, Corée, République de, Taïwan, Canada, Australie, Allemagne, Tchéquie, Pologne, Hongrie, Japon, Royaume-Uni, Argentine, Chili, Colombie, Mexique, Fédération Russe