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A Study To Assess The Safety Of PF-05335810 In Hypercholesterolemic Subjects

30. november 2018 opdateret af: Pfizer

A Phase I, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Single, Ascending Doses Of PF-05335810 In Hypercholesterolemic Subjects, With One, Open-Label, Multiple Fixed Dosage Cohort

This study is to evaluate the safety, tolerability and immunogenicity of single, ascending or multiple fixed subcutaneous and intravenous administrations of PF 05335810 to hypercholesterolemic subjects when added on to a daily statin dose.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

133

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
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06511
        • Pfizer Investigational Site
    • Florida
      • Miami, Florida, Forenede Stater, 33169
        • Pfizer Investigational Site
      • South Miami, Florida, Forenede Stater, 33143
        • Pfizer Investigational Site
    • Kansas
      • Overland Park, Kansas, Forenede Stater, 66212
        • Pfizer Investigational Site
    • Michigan
      • Kalamazoo, Michigan, Forenede Stater, 49007
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45227
        • Pfizer Investigational Site
    • Texas
      • San Antonio, Texas, Forenede Stater, 78209
        • Pfizer Investigational Site

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:

  • On stable daily doses of a statin for 45 days prior to receiving study treatment.
  • Fasting LDL C equal or greater than 80 mg/dL at screening and visit approximately 1 week prior to randomization.

Exclusion Criteria:

  • History of a cardiovascular or cerebrovascular event or procedure within one year of randomization.
  • Poorly controlled type 1 or type 2 diabetes mellitus (defined as HbA1c >9%).

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: Enkelt gruppeopgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Kohorte 1
Biologisk: PF-05335810 Dose A
Single SC Injection
Eksperimentel: Kohorte 2
Biologisk: PF-05335810 Dose B
Single Subcutaneous Injection(s)
Biologisk: Placebo
Single Subcutaneous Injection(s)
Biologisk: PF-05335810 Dose B
Single Intravenous Infusion
Biologisk: Placebo
Single Intravenous Infusion
Biologisk: PF-04950615 Dose A
Single Subcutaneous Injection(s)
Biologisk: PF-04950615 Dose A
Single Intravenous Infusion
Eksperimentel: Kohorte 3
Biologisk: Placebo
Single Subcutaneous Injection(s)
Biologisk: Placebo
Single Intravenous Infusion
Biologisk: PF-05335810 Dose C
Single Subcutaneous Injection(s)
Biologisk: PF-05335810 Dose C
Single Intravenous Infusion
Biologisk: PF-04950615
Single Subcutaneous Injection(s)
Eksperimentel: Kohorte 4
Biologisk: Placebo
Single Subcutaneous Injection(s)
Biologisk: Placebo
Single Intravenous Infusion
Biologisk: PF-05335810 Dose D
Single Subcutaneous Injection(s)
Biologisk: PF-05335810 Dose D
Single Intravenous Infusion
Eksperimentel: Kohorte 5
Biologisk: PF-05335810 Dose E
Multiple fixed dosages administered in subcutaneous injections, monthly for 3 months.
Eksperimentel: Kohorte 6
Biologisk: Placebo
Single Subcutaneous Injection(s)
Biologisk: Placebo
Single Intravenous Infusion
Biologisk: PF-05335810 Dose D
Single Subcutaneous Injection(s)
Biologisk: PF-05335810 Dose D
Single Intravenous Infusion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: Baseline up to Day 85/169 or Early Termination (ET)
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Baseline up to Day 85/169 or Early Termination (ET)
Number of Participants With Laboratory Test Values of Potential Clinical Importance
Tidsramme: Baseline up to Day 85/169 or Early Termination (ET)
Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance.
Baseline up to Day 85/169 or Early Termination (ET)
Change From Baseline in Heart Rate
Tidsramme: Baseline, Day 1 to 85/169 or ET
Baseline, Day 1 to 85/169 or ET
Diastolic Blood Pressure
Tidsramme: Baseline, Day 1 to 85/169 or ET
Baseline, Day 1 to 85/169 or ET
Change From Baseline in Electrocardiogram (ECG) Parameters
Tidsramme: Baseline, Day 1 to 85/169 or ET
Baseline, Day 1 to 85/169 or ET
Number of Participants With Laboratory Test Values of Potential Clinical Importance
Tidsramme: Baseline, Day 1 to 85/169 or ET
Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance.
Baseline, Day 1 to 85/169 or ET

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Tidsramme: Day1 pre-dose to Day 85/169 or ET
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
Day1 pre-dose to Day 85/169 or ET
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
Tidsramme: Day1 pre-dose to Day 85/169 or ET
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Day1 pre-dose to Day 85/169 or ET
Maximum Observed Plasma Concentration (Cmax)
Tidsramme: Day1 pre-dose to Day 85/169 or ET
Day1 pre-dose to Day 85/169 or ET
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Tidsramme: Day1 pre-dose to Day 85/169 or ET
Day1 pre-dose to Day 85/169 or ET
Apparent Volume of Distribution (Vz/F)
Tidsramme: Day1 pre-dose to Day 85/169 or ET
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Day1 pre-dose to Day 85/169 or ET
Apparent Oral Clearance (CL/F)
Tidsramme: Day1 pre-dose to Day 85/169 or ET
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Day1 pre-dose to Day 85/169 or ET
Plasma Decay Half-Life (t1/2)
Tidsramme: Day1 pre-dose to Day 85/169 or ET
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Day1 pre-dose to Day 85/169 or ET
Absolute Bioavailability (%F)
Tidsramme: Day1 pre-dose to Day 85/169 or ET
Day1 pre-dose to Day 85/169 or ET

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. juli 2012

Primær færdiggørelse (Faktiske)

1. oktober 2013

Studieafslutning (Faktiske)

1. oktober 2013

Datoer for studieregistrering

Først indsendt

3. august 2012

Først indsendt, der opfyldte QC-kriterier

31. oktober 2012

Først opslået (Skøn)

2. november 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. december 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. november 2018

Sidst verificeret

1. november 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • B3091001

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 PF-05335810 Dose A

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Betingelser

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Sponsor / samarbejdspartnere

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