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A Study to Evaluate the Pharmacodynamic Effects of Single Oral Doses of PF-06648671 on β-Amyloid (Aβ) Concentrations in Cerebrospinal Fluid (CSF)

21. marts 2016 opdateret af: Pfizer

A Phase 1 Investigator-and-subject Blind, Randomized, Placebo Controlled, Parallel Study In Healthy Subjects To Evaluate The Pharmacodynamic Effects Of Single Oral Doses Of Pf-06648671 On Aβ Concentrations In Cerebrospinal Fluid Using Serial Sampling Methodology

This is phase 1 investigator-and-subject blind, sponsor open, randomized, placebo controlled, parallel study in healthy subjects to evaluate the pharmacodynamics effect of single oral doses of PF-06648671 on CSF Aβ concentrations using serial CSF sampling methodology.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study is investigator-and-subject blind, sponsor open, randomized, placebo-controlled, parallel study in healthy subjects to evaluate central (CSF) and peripheral (plasma) pharmacodynamics effects (Abeta) over 36 hours post single doses of PF-06648671. Two cohorts will be run in sequential. the first cohort is to evaluate the Abeta effect at top dose of 300 mg PF-06648671 and second cohort is to evaluate the Abeta effect at top dose (if more subjects are required) and/or 1-2 lower doses

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

22

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
    • California
      • Glendale, California, Forenede Stater, 91206
        • Glendale Adventist Medical Center
      • Glendale, California, Forenede Stater, 91206
        • California Clinical Trials Medical Group, 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 55 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Healthy male and/or female subjects of non childbearing potential
  • BMI of 17.5 to 30.5 kg/m2 and a total body weight >50 kg (110 lbs)
  • Evidence of a personally signed and dated informed consent document indicating that subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated asymptomatic, seasonal allergies at the time of dosing)
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study medication (whichever is longer)
  • Subjects with a history of significant active bleeding, coagulation disorder or clinically significant finding on prothrombin time/ partial thromboplastin time/International Normalized Ratio (PT/PTT/INR) at Screening
  • Subjects with lower spinal malformations (on physical examination), local spinal infection, or other abnormalities that would exclude puncture (LP)
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study

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: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: PF-06648671 High dose group
subjects receive a single oral dose of PF-06648671 at 300 mg
Medicin: PF-06648671
Experimental Pfizer compound which will be dosed as oral suspension, single dose at 300 mg and/or 1-2 lower doses
Eksperimentel: PF-06648671 Low dose group
Subjects receive a single oral dose of PF-06648671 lower than 300 mg dose
Medicin: PF-06648671
Experimental Pfizer compound which will be dosed as oral suspension, single dose at 300 mg and/or 1-2 lower doses
Placebo komparator: Placebo group
Subjects receive matching placebo
Medicin: Placebo
Placebo which will be dosed as oral suspension, single doses to match PF-06648671
Eksperimentel: PF-06648671 Low dose group (2)
Optional arm. Subjects receive a single oral dose of PF-06648671 at second lower dose if 300 mg dose is not repeated in cohort 2
Medicin: PF-06648671
Experimental Pfizer compound which will be dosed as oral suspension, single dose at 300 mg and/or 1-2 lower doses

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
CSF Aβ40 and Aβ42 concentration at maximum change from baseline
Tidsramme: 0-36 hours postdose
0-36 hours postdose

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of participants with AEs and SAEs
Tidsramme: 0-2 weeks
Counts of participants who have TEAEs, defined as newly occuring or worsening after first dose. Relatedness to PF-06648671 will be assessed by the investigator (Yes/No). Participants with multiple occurrence of an AE within a category will be counted once within the category
0-2 weeks
supine vital sign
Tidsramme: 0-2 weeks
Measurement of supine vital signs
0-2 weeks
Electrocardiogram (ECG)
Tidsramme: 0-2 weeks
Measurement of standard 12-lead ECG (single)
0-2 weeks
Maximum Observed Plasma Concentration (Cmax)
Tidsramme: 0-72 hours postdose
0-72 hours postdose
Area Under the Curve from Time Zero to Last Quantifiable Plasma Concentration (AUClast)
Tidsramme: 0-72 hours postdose
0-72 hours postdose
Area Under the Curve From Time Zero to Extrapolated Infinite Time in Plasma (AUCinf)
Tidsramme: 0-72 hours postdose
0-72 hours postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Tidsramme: 0-72 hours postdose
0-72 hours postdose
Plasma Decay Half-life (t1/2)
Tidsramme: 0-72 hours postdose
0-72 hours postdose
Apparent Oral Clearance (CL/F)
Tidsramme: 0-72 hours postdose
0-72 hours postdose
Apparent Volume of Distribution (Vz/F))
Tidsramme: 0-72 hours postdose
0-72 hours postdose
Maximum Observed CSF Concentration (CSF Cmax)
Tidsramme: 0-36 hours postdose
0-36 hours postdose
Area Under the Curve from Time Zero to Last Quantifiable Concentration in CSF (CSF AUClast)
Tidsramme: 0-36 hours postdose
0-36 hours postdose
Area Under the Curve From Time Zero to Extrapolated Infinite Time in CSF (CSF AUCinf)
Tidsramme: 0-36 hours postdose
0-36 hours postdose
CSF Decay Half-life (CSF t1/2)
Tidsramme: 0-36 hours postdose
0-36 hours postdose
Plasma Aβ40, Aβ42 and Aβtotal
Tidsramme: 0-72 hours postdose
Plasma Aβ40, Aβ42 and Aβtotal if possible
0-72 hours postdose
CSF Aβ37, Aβ38 and Aβtotal Concentration
Tidsramme: 0-36 hours postdose
0-36 hours postdose
Number of participants with lab test values of potential clinical importance
Tidsramme: 0-2 weeks
Pre-defined criteria were established for each lab test to identify potential clinical importance
0-2 weeks

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.

Generelle publikationer

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. oktober 2015

Primær færdiggørelse (Faktiske)

1. marts 2016

Studieafslutning (Faktiske)

1. marts 2016

Datoer for studieregistrering

Først indsendt

25. marts 2015

Først indsendt, der opfyldte QC-kriterier

30. marts 2015

Først opslået (Skøn)

2. april 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

22. marts 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. marts 2016

Sidst verificeret

1. marts 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • B7991003

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-06648671

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Lebanon

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner