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Study To Compare Single Dose Of Three Modified Release Formulations Of PF-04937319 With Immediate Release Material-Sparing-Tablet (IR MST) Formulation Previously Studied In Adults With Type 2 Diabetes Mellitus.

4. februar 2016 opdateret af: Pfizer

A Phase 1, Randomized, Open-label, Cross-over, Single-day Study Of Pf-04937319 To Characterize Relative Bioavailability, Tolerability, And Pharmacodynamics Of Four Oral Formulations In Adults With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin

Study B1621015 will characterize bioavailability, tolerability and pharmacodynamics of three modified release formulations of PF-04937319 compared with the immediate release material-sparing-tablet (IR MST) formulation in adults with type 2 diabetes.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

39

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • North Carolina
      • High Point, North Carolina, Forenede Stater, 27265
        • High Point Clinical Trials Center
    • Texas
      • San Antonio, Texas, Forenede Stater, 78229
        • Clinical Trials of Texas, Inc.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Adults with type 2 diabetes, on stable background metformin therapy either alone or in combination with another oral anti-diabetic agent (OAD) excluding thiazolidinediones (TZDs)

Exclusion Criteria:

  • Patients with cardiovascular event within 6 months of screening
  • Patients with diabetic complications
  • Female subjects who are pregnant or planning to become pregnant
  • Subjects with unstable medical conditions (eg, hypertension)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: PF-04937319 IR MST
Reference formulation
Medicin: PF-04937319 IR MST
Immediate release material sparing tablet (IR MST) administered as 150 mg with morning meal and 100 mg with lunch
Eksperimentel: PF-04937319 MR 1
Test MR #1
Medicin: PF-04937319 MR 1
Modified release formulation #1 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
Eksperimentel: PF-04937319 MR 2
Test MR #2
Medicin: PF-04937319 MR 2
Modified release formulation #2 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
Eksperimentel: PF-04937319 MR 3
Test MR #3
Medicin: PF-04937319 MR 3
Modified release formulation #3 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]
Tidsramme: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
AUCinf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.
0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
Change From Reference in Weighted-Mean-Daily-Glucose (WMDG) on Day 1
Tidsramme: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, and 24 hours post-dose
MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed.
0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, and 24 hours post-dose

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum Observed PF-04937319 Plasma Concentration (Cmax)
Tidsramme: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
PF-04937319 Plasma Concentration at 5 Hours After Morning Dose (C5)
Tidsramme: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
PF-04937319 Plasma Concentration at 16 Hours After Morning Dose (C16)
Tidsramme: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
PF-04937319 Plasma Concentration at 24 Hours After Morning Dose (C24)
Tidsramme: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
Ratio of Maximum to Approximate Trough PF-04937319 Concentration (Cmax/C24)
Tidsramme: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
Cmax/C24 is the ratio of maximum to approximate trough concentration, where Cmax is the overall maximum observed plasma concentration and C24 is the plasma concentration at 24 hours after the morning dose.
0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
Time to Reach Maximum Observed PF-04937319 Plasma Concentration (Tmax)
Tidsramme: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable PF-04937319 Concentration (AUClast)
Tidsramme: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
Terminal Elimination Half-Life (t1/2)
Tidsramme: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
t1/2 is the time measured for the plasma concentration to decrease by one half.
0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Tidsramme: Baseline up to 28 days after last study drug administration in Period 4
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
Baseline up to 28 days after last study drug administration in Period 4

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2014

Primær færdiggørelse (Faktiske)

1. januar 2015

Studieafslutning (Faktiske)

1. januar 2015

Datoer for studieregistrering

Først indsendt

30. juli 2014

Først indsendt, der opfyldte QC-kriterier

30. juli 2014

Først opslået (Skøn)

1. august 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. marts 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. februar 2016

Sidst verificeret

1. februar 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • B1621015

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Type 2 diabetes mellitus

Kliniske forsøg med PF-04937319 IR MST

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Denmark

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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