The Dose Response of Prednisone on Biochemical and Clinical Makers in Adult Healthy Volunteers
6 mai 2016 mis à jour par: Pfizer
A Randomized, Single-blind, Placebo-controlled, Crossover Studyto Assess The Dose Response Of Prednisone On Biochemical Andclinical Markers Of Efficacy And Safety In Adult Healthyvolunteers
The purpose of this study is to further access the utility of biochemical and clinical biomarkers for glucocorticoid-mediated anti-inflammatory effects and safety endpoints against which dissociated agonists of the glucocorticoid receptor (DAGR) will be evaluated in adult healthy volunteers.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
37
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
-
-
Michigan
-
Kalamazoo, Michigan, États-Unis, 49007
- Jasper Clinic, Inc.
-
-
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 or females willing to be confined and comply with scheduled visits
- Women are to be surgically sterile.
Exclusion Criteria:
- History of febrile illness within 5 days prior to the first dose
- Positive urine drug screen
- Treatment with an investigational product within 30 days prior to the first dose of study medication
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
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Sequence A
Period 1: Placebo Period 2: Prednisone 2.5 mg Period 3: Prednisone 10 mg
|
Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized.
Subjects are to be dosed each morning for 7 days.
A 14 day washout period is required between each period.
Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
Placebo tablets similar to Prednisone 2.5 mg and 20 mg were supplied to make the trial doses.
|
|
Autre: Sequence B
Period 1: Prednisone 2.5 mg Period 2: Prednisone 5 mg Period 3: Prednisone 20 mg
|
Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized.
Subjects are to be dosed each morning for 7 days.
A 14 day washout period is required between each period.
Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
|
|
Autre: Sequence C
Period 1: Prednisone 5 mg Period 2: Prednisone 10 mg Period 3: Prednisone 40 mg
|
Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized.
Subjects are to be dosed each morning for 7 days.
A 14 day washout period is required between each period.
Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
|
|
Autre: Sequence D
Period 1: Prednisone 10 mg Period 2: Prednisone 20 mg Period 3: Prednisone 60 mg
|
Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized.
Subjects are to be dosed each morning for 7 days.
A 14 day washout period is required between each period.
Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
|
|
Autre: Sequence E
Period 1: Prednisone 20 mg Period 2: Prednisone 40 mg Period 3: Placebo
|
Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized.
Subjects are to be dosed each morning for 7 days.
A 14 day washout period is required between each period.
Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
Placebo tablets similar to Prednisone 2.5 mg and 20 mg were supplied to make the trial doses.
|
|
Autre: Sequence F
Period 1: Prednisone 40 mg Period 2: Prednisone 60 mg Period 3: Prednisone 2.5 mg
|
Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized.
Subjects are to be dosed each morning for 7 days.
A 14 day washout period is required between each period.
Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
|
|
Autre: Sequence G
Period 1: Prednisone 60 mg Period 2: Placebo Period 3: Prednisone 5 mg
|
Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized.
Subjects are to be dosed each morning for 7 days.
A 14 day washout period is required between each period.
Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
Placebo tablets similar to Prednisone 2.5 mg and 20 mg were supplied to make the trial doses.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on osteocalcin
Délai: 8 days
|
The change in serum osteocalcin from baseline after treatment on Day 1 and Day 8 will be assessed in each treatment period
|
8 days
|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Cortisol Suppression
Délai: 8 days
|
Change from baseline in serum cortisol after treatment on Day 1 and Day 8 in each treatment period
|
8 days
|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on HPA Axis Suppression
Délai: 14 days after the last study visit in Period 3, if repeat testing required will be done 28 days after first test
|
Serum cortisol in response to low-dose ACTH Stimulation Test will be completed at the end of Period 3 for each subject
|
14 days after the last study visit in Period 3, if repeat testing required will be done 28 days after first test
|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on White Blood Cell Counts
Délai: 8 days
|
Change from baseline in blood leukocytes (neutrophils, lymphocytes and eosinophils) in each treatment period
|
8 days
|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Procollagen type 1-N-Propeptide (P1NP)
Délai: 8 days
|
The change from baseline in serum P1NP after treatment on Day 1 and Day 8 will be assessed in each treatment period
|
8 days
|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Urinary N-terminal cross-linked telopeptide of type 1 collagen (uNTX-1)
Délai: 8 days
|
Change from baseline in uNTX-1 will be assessed on Day 1 and Day 8 after treatment in each treatment period
|
8 days
|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Fasting glucose and insulin
Délai: 8 days
|
Glucose and insulin will be assessed for the change from baseline after 7 days of treatment on Day 8 in each treatment period
|
8 days
|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on an Oral Glucose Tolerance Test
Délai: Day 6
|
On Day 6 of each period, subjects will undergo an oral glucose tolerance test.
After ingesting 75 g of a glucose solution within 5 minutes of receiving their daily dose of prednisone, blood samples for glucose were obtained at 0.5, 1 and 2 hours.
|
Day 6
|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Triglycerides
Délai: 8 days
|
Change from baseline in triglycerides will be assessed after 7 days of treatment on Day 8 in each treatment period
|
8 days
|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Urinary Cortisol Suppression
Délai: 7 days
|
Change from baseline in 24-hour urinary cortisol on Day 7 in each treatment period
|
7 days
|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Adiponectin
Délai: 8 days
|
Change from baseline in adiponectin will be assessed after 7 days of treatment on Day 8 in each treatment period
|
8 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Profile of Mood State
Délai: 7 days
|
Change from baseline after 7 days of treatment in each treatment period.
The POMS is a copyrighted questionnaire that measures 6 dimensions of mood.
The subject will assess how 65 descriptors apply to him/her on a 5-point scale of 0 (not at all) to 4 (extremely).
|
7 days
|
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Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Medical Outcomes: Sleep Scale (MOS-Sleep)
Délai: 7 days
|
Change from baseline in sleep after 7 days of treatment will be assessed in each treatment period.
The patient-reported questionnaire consists of 12 items that assesses the key constructs of sleep.
Scores can range from 12-71 with higher number indicating more problems with sleep.
|
7 days
|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on the Incidence of Adverse Events
Délai: 28 days after last dose of study medication in Period 3
|
Subjects were monitored throughout the study and queried for adverse events
|
28 days after last dose of study medication in Period 3
|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Blood Pressure
Délai: 8 days
|
Blood pressure will be assessed for change from baseline after 7 days of treatment on Day 8 in each treatment period
|
8 days
|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Weight
Délai: 8 days
|
A post-void weight will be collected on the morning of Day 1 and Day 8 to assess change from baseline during each treatment period.
|
8 days
|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on pulse rate
Délai: 8 days
|
Pulse rate will be assessed for change from baseline after 7 days of treatment on Day 8 in each treatment period
|
8 days
|
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 octobre 2005
Achèvement primaire (Réel)
1 mars 2006
Achèvement de l'étude (Réel)
1 mars 2006
Dates d'inscription aux études
Première soumission
21 avril 2016
Première soumission répondant aux critères de contrôle qualité
6 mai 2016
Première publication (Estimation)
10 mai 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
10 mai 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 mai 2016
Dernière vérification
1 mai 2016
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- A9001309
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