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A Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-06282999 Administered Orally In Healthy Adult Subjects

12. marts 2013 opdateret af: Pfizer

A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo Controlled, Single Dose Escalating Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-06282999 Administered Orally In Healthy Adult Subjects

This is the first-in-human study for an oral investigational compound, PF-06282999, in order to assess its safety, tolerability and pharmacokinetics in humans across a wide range of dose levels.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

42

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Belgien
      • Bruxelles, Belgien, B-1070
        • 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 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 between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
  • Women must be of non-childbearing potential.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of ≤1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Kohorte 1
Medicin: PF-06282999
Solution, doses range from 20 to 200 mg, single dose
Medicin: Placebo
Solution, single dose
Medicin: PF-06282999
Methylcellulose suspension, doses range 125 to 500 mg, single dose
Medicin: Placebo
suspension, single dose
Medicin: PF-06282999
Methylcellulose or simethicone suspension, doses range 200 to 500 mg, single dose
Medicin: PF-06282999
Methylcellulose or simethicone suspension, 500 mg dose, single dose
Medicin: PF-06282999
Simethicone or methylcellulose suspension, up to 1500 mg, single dose
Eksperimentel: Kohorte 2
Medicin: PF-06282999
Solution, doses range from 20 to 200 mg, single dose
Medicin: Placebo
Solution, single dose
Medicin: PF-06282999
Methylcellulose suspension, doses range 125 to 500 mg, single dose
Medicin: Placebo
suspension, single dose
Medicin: PF-06282999
Methylcellulose or simethicone suspension, doses range 200 to 500 mg, single dose
Medicin: PF-06282999
Methylcellulose or simethicone suspension, 500 mg dose, single dose
Medicin: PF-06282999
Simethicone or methylcellulose suspension, up to 1500 mg, single dose
Eksperimentel: Kohorte 3
Medicin: PF-06282999
Solution, doses range from 20 to 200 mg, single dose
Medicin: Placebo
Solution, single dose
Medicin: PF-06282999
Methylcellulose suspension, doses range 125 to 500 mg, single dose
Medicin: Placebo
suspension, single dose
Medicin: PF-06282999
Methylcellulose or simethicone suspension, doses range 200 to 500 mg, single dose
Medicin: PF-06282999
Methylcellulose or simethicone suspension, 500 mg dose, single dose
Medicin: PF-06282999
Simethicone or methylcellulose suspension, up to 1500 mg, single dose
Eksperimentel: Kohorte 4
Medicin: PF-06282999
Solution, doses range from 20 to 200 mg, single dose
Medicin: Placebo
Solution, single dose
Medicin: PF-06282999
Methylcellulose suspension, doses range 125 to 500 mg, single dose
Medicin: Placebo
suspension, single dose
Medicin: PF-06282999
Methylcellulose or simethicone suspension, doses range 200 to 500 mg, single dose
Medicin: PF-06282999
Methylcellulose or simethicone suspension, 500 mg dose, single dose
Medicin: PF-06282999
Simethicone or methylcellulose suspension, up to 1500 mg, single dose
Eksperimentel: Kohorte 5
Medicin: PF-06282999
Solution, doses range from 20 to 200 mg, single dose
Medicin: Placebo
Solution, single dose
Medicin: PF-06282999
Methylcellulose suspension, doses range 125 to 500 mg, single dose
Medicin: Placebo
suspension, single dose
Medicin: PF-06282999
Methylcellulose or simethicone suspension, doses range 200 to 500 mg, single dose
Medicin: PF-06282999
Methylcellulose or simethicone suspension, 500 mg dose, single dose
Medicin: PF-06282999
Simethicone or methylcellulose suspension, up to 1500 mg, single dose

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]
Tidsramme: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Tidsramme: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
Area Under the Curve From Time Zero to 24 hour [AUC24]
Tidsramme: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose
Maximum Observed Plasma Concentration (Cmax)
Tidsramme: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Tidsramme: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
Apparent Oral Clearance (CL/F)
Tidsramme: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
Plasma Decay Half-Life (t1/2)
Tidsramme: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
Apparent Volume of Distribution (Vz/F)
Tidsramme: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
Amount of Unchanged Drug Excretion in Urine from Zero to 24 hours (Ae24)
Tidsramme: 0 to 24 hours post-dose
0 to 24 hours post-dose
Percent of Dose Excreted in Urine as Unchanged Drug from Zero to 24 hours (Ae24%)
Tidsramme: 0 to 24 hours post-dose
0 to 24 hours post-dose
Renal Clearance (CLr)
Tidsramme: 0 to 24 hours post-dose
0 to 24 hours post-dose
Oral temperature
Tidsramme: 0, 1, 2, 4, 8, 12,16, 24, 48 hours post-dose
0, 1, 2, 4, 8, 12,16, 24, 48 hours post-dose

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. juni 2012

Primær færdiggørelse (Faktiske)

1. marts 2013

Studieafslutning (Faktiske)

1. marts 2013

Datoer for studieregistrering

Først indsendt

30. maj 2012

Først indsendt, der opfyldte QC-kriterier

20. juni 2012

Først opslået (Skøn)

25. juni 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. marts 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. marts 2013

Sidst verificeret

1. marts 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • B5211001

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-06282999

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Portugal

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner