A Multiple Oral Doses Study Of PF-06427878 In Healthy Adult Subjects
1 mars 2016 mis à jour par: Pfizer
A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Multiple Escalating Oral Doses Of Pf-06427878 Co Administered With And Without Food In Healthy Adult Subjects
PF-06427878 is a new compound proposed for the treatment of hyperlipidemia.
The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple oral doses of PF-06427878 in healthy adult subjects.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
40
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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Brussels, Belgique, B-1070
- Pfizer Clinical Research Unit
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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
18 ans à 55 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Healthy male and/or female subjects of non childbearing potential.
- Body Mass Index (BMI) of 17.5 to 35.4 kg/m2; and a total body weight >50 kg
- Subjects with fasting TG level of >=90 mg/dL and <=500 mg/dL following an overnight fast
- Subjects with low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL following an overnight fast
Exclusion Criteria:
•Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
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
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Cohort 1
Single dose level of PF-06427878 at 5 mg or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
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Expérimental: Cohort 2
Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 1 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
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Expérimental: Cohort 3
Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 2 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
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Expérimental: Cohort 4
Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 3 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
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Expérimental: Cohort 5
Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 4 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
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Expérimental: Cohort 6
Single dose level of PF-06427878 (with the same total daily dose as Cohort 5) or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Assessment of adverse events (AEs).
Délai: 0-25 days
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0-25 days
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Assessment of clinical laboratory tests.
Délai: 0-25 days
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0-25 days
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Assessment of vital signs (including blood pressure and pulse rate).
Délai: 0-25 days
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0-25 days
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Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG).
Délai: 0-25 days
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0-25 days
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Maximum Observed Plasma Concentration (Cmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1
Délai: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Maximum Observed Plasma Concentration (Cmax) for PF-06427878during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12
Délai: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 14
Délai: 0, 1, 2, 3, 4, 6, 8, 12 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12 hours post dose
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1
Délai: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12
Délai: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Délai: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1
Délai: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12
Délai: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Délai: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Plasma Decay Half-Life (t1/2) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Délai: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Apparent Volume of Distribution (Vz/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Délai: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Apparent Oral Clearance (CL/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Délai: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Minimum Observed Plasma Concentration (Cmin) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Délai: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Peak:Trough ratio of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Délai: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1
Délai: 0, 1, 2, 3, 4, 6, 8, 12 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12 hours post dose
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Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD
Délai: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUCtau)) for PF-06427878 on day14 relative to day 1
Délai: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Amount of PF-06427878 excreted in urine (Ae) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Délai: 0- tau hours post dose
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0- tau hours post dose
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Percent of dose excreted in urine as PF-06427878 (Ae%) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Délai: 0- tau hours post dose
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0- tau hours post dose
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Renal clearance of PF-06427878 (CLr) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Délai: 0- tau hours post dose
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0- tau hours post dose
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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 mars 2015
Achèvement primaire (Réel)
1 février 2016
Achèvement de l'étude (Réel)
1 février 2016
Dates d'inscription aux études
Première soumission
12 mars 2015
Première soumission répondant aux critères de contrôle qualité
12 mars 2015
Première publication (Estimation)
18 mars 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
2 mars 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 mars 2016
Dernière vérification
1 mars 2016
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- B7871002
- 2015-000130-29 (Numéro EudraCT)
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