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

6. mai 2016 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

37

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Michigan
      • Kalamazoo, Michigan, Forente stater, 49007
        • Jasper Clinic, Inc.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 55 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Sequence A
Period 1: Placebo Period 2: Prednisone 2.5 mg Period 3: Prednisone 10 mg
Legemiddel: 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.
Legemiddel: Placebo
Placebo tablets similar to Prednisone 2.5 mg and 20 mg were supplied to make the trial doses.
Annen: Sequence B
Period 1: Prednisone 2.5 mg Period 2: Prednisone 5 mg Period 3: Prednisone 20 mg
Legemiddel: 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.
Annen: Sequence C
Period 1: Prednisone 5 mg Period 2: Prednisone 10 mg Period 3: Prednisone 40 mg
Legemiddel: 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.
Annen: Sequence D
Period 1: Prednisone 10 mg Period 2: Prednisone 20 mg Period 3: Prednisone 60 mg
Legemiddel: 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.
Annen: Sequence E
Period 1: Prednisone 20 mg Period 2: Prednisone 40 mg Period 3: Placebo
Legemiddel: 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.
Legemiddel: Placebo
Placebo tablets similar to Prednisone 2.5 mg and 20 mg were supplied to make the trial doses.
Annen: Sequence F
Period 1: Prednisone 40 mg Period 2: Prednisone 60 mg Period 3: Prednisone 2.5 mg
Legemiddel: 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.
Annen: Sequence G
Period 1: Prednisone 60 mg Period 2: Placebo Period 3: Prednisone 5 mg
Legemiddel: 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.
Legemiddel: Placebo
Placebo tablets similar to Prednisone 2.5 mg and 20 mg were supplied to make the trial doses.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on osteocalcin
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 8 days
Change from baseline in adiponectin will be assessed after 7 days of treatment on Day 8 in each treatment period
8 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Profile of Mood State
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pfizer

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2005

Primær fullføring (Faktiske)

1. mars 2006

Studiet fullført (Faktiske)

1. mars 2006

Datoer for studieregistrering

Først innsendt

21. april 2016

Først innsendt som oppfylte QC-kriteriene

6. mai 2016

Først lagt ut (Anslag)

10. mai 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

10. mai 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. mai 2016

Sist bekreftet

1. mai 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • A9001309

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