The Dose Response of Prednisone on Biochemical and Clinical Makers in Adult Healthy Volunteers
6. Mai 2016 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
37
Phase
- Phase 1
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Michigan
-
Kalamazoo, Michigan, Vereinigte Staaten, 49007
- Jasper Clinic, Inc.
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 55 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Sonstiges: 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.
|
|
Sonstiges: 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.
|
|
Sonstiges: 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.
|
|
Sonstiges: 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.
|
|
Sonstiges: 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.
|
|
Sonstiges: 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.
|
|
Sonstiges: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on osteocalcin
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 8 days
|
Change from baseline in adiponectin will be assessed after 7 days of treatment on Day 8 in each treatment period
|
8 days
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on Profile of Mood State
Zeitfenster: 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)
Zeitfenster: 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.
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7 days
|
|
Characterize the dose-response effect of prednisone 2.5, 5, 10, 20, 40 and 60 mg on the Incidence of Adverse Events
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Oktober 2005
Primärer Abschluss (Tatsächlich)
1. März 2006
Studienabschluss (Tatsächlich)
1. März 2006
Studienanmeldedaten
Zuerst eingereicht
21. April 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
6. Mai 2016
Zuerst gepostet (Schätzen)
10. Mai 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
10. Mai 2016
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
6. Mai 2016
Zuletzt verifiziert
1. Mai 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- A9001309
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