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The Dose Response of Prednisone on Biochemical and Clinical Makers in Adult Healthy Volunteers

6 maggio 2016 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

37

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Michigan
      • Kalamazoo, Michigan, Stati Uniti, 49007
        • Jasper Clinic, Inc.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 55 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: Sequence A
Period 1: Placebo Period 2: Prednisone 2.5 mg Period 3: Prednisone 10 mg
Droga: Prednisone
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.
Droga: Placebo
Placebo tablets similar to Prednisone 2.5 mg and 20 mg were supplied to make the trial doses.
Altro: Sequence B
Period 1: Prednisone 2.5 mg Period 2: Prednisone 5 mg Period 3: Prednisone 20 mg
Droga: Prednisone
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.
Altro: Sequence C
Period 1: Prednisone 5 mg Period 2: Prednisone 10 mg Period 3: Prednisone 40 mg
Droga: Prednisone
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.
Altro: Sequence D
Period 1: Prednisone 10 mg Period 2: Prednisone 20 mg Period 3: Prednisone 60 mg
Droga: Prednisone
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.
Altro: Sequence E
Period 1: Prednisone 20 mg Period 2: Prednisone 40 mg Period 3: Placebo
Droga: Prednisone
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.
Droga: Placebo
Placebo tablets similar to Prednisone 2.5 mg and 20 mg were supplied to make the trial doses.
Altro: Sequence F
Period 1: Prednisone 40 mg Period 2: Prednisone 60 mg Period 3: Prednisone 2.5 mg
Droga: Prednisone
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.
Altro: Sequence G
Period 1: Prednisone 60 mg Period 2: Placebo Period 3: Prednisone 5 mg
Droga: Prednisone
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.
Droga: Placebo
Placebo tablets similar to Prednisone 2.5 mg and 20 mg were supplied to make the trial doses.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on osteocalcin
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 8 days
Change from baseline in adiponectin will be assessed after 7 days of treatment on Day 8 in each treatment period
8 days

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Profile of Mood State
Lasso di tempo: 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
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Medical Outcomes: Sleep Scale (MOS-Sleep)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2005

Completamento primario (Effettivo)

1 marzo 2006

Completamento dello studio (Effettivo)

1 marzo 2006

Date di iscrizione allo studio

Primo inviato

21 aprile 2016

Primo inviato che soddisfa i criteri di controllo qualità

6 maggio 2016

Primo Inserito (Stima)

10 maggio 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

10 maggio 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 maggio 2016

Ultimo verificato

1 maggio 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • A9001309

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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