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A Multiple Oral Doses Study Of PF-06427878 In Healthy Adult Subjects

1 maart 2016 bijgewerkt door: Pfizer

A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Multiple Escalating Oral Doses Of Pf-06427878 Co Administered With And Without Food In Healthy Adult Subjects

PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple oral doses of PF-06427878 in healthy adult subjects.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

40

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • België
      • Brussels, België, B-1070
        • Pfizer Clinical Research Unit

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 55 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Healthy male and/or female subjects of non childbearing potential.
  • Body Mass Index (BMI) of 17.5 to 35.4 kg/m2; and a total body weight >50 kg
  • Subjects with fasting TG level of >=90 mg/dL and <=500 mg/dL following an overnight fast
  • Subjects with low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL following an overnight fast

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 time of dosing).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Cohort 1
Single dose level of PF-06427878 at 5 mg or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Geneesmiddel: PF-06427878
PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Geneesmiddel: Placebo
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
Geneesmiddel: PF-06427878
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Geneesmiddel: Placebo
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
Experimenteel: Cohort 2
Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 1 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Geneesmiddel: PF-06427878
PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Geneesmiddel: Placebo
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
Geneesmiddel: PF-06427878
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Geneesmiddel: Placebo
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
Experimenteel: Cohort 3
Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 2 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Geneesmiddel: PF-06427878
PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Geneesmiddel: Placebo
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
Geneesmiddel: PF-06427878
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Geneesmiddel: Placebo
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
Experimenteel: Cohort 4
Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 3 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Geneesmiddel: PF-06427878
PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Geneesmiddel: Placebo
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
Geneesmiddel: PF-06427878
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Geneesmiddel: Placebo
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
Experimenteel: Cohort 5
Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 4 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Geneesmiddel: PF-06427878
PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Geneesmiddel: Placebo
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
Geneesmiddel: PF-06427878
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Geneesmiddel: Placebo
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
Experimenteel: Cohort 6
Single dose level of PF-06427878 (with the same total daily dose as Cohort 5) or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Geneesmiddel: PF-06427878
PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Geneesmiddel: Placebo
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
Geneesmiddel: PF-06427878
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Geneesmiddel: Placebo
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Assessment of adverse events (AEs).
Tijdsspanne: 0-25 days
0-25 days
Assessment of clinical laboratory tests.
Tijdsspanne: 0-25 days
0-25 days
Assessment of vital signs (including blood pressure and pulse rate).
Tijdsspanne: 0-25 days
0-25 days
Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG).
Tijdsspanne: 0-25 days
0-25 days

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Maximum Observed Plasma Concentration (Cmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1
Tijdsspanne: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06427878during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12
Tijdsspanne: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 14
Tijdsspanne: 0, 1, 2, 3, 4, 6, 8, 12 hours post dose
0, 1, 2, 3, 4, 6, 8, 12 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1
Tijdsspanne: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12
Tijdsspanne: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Tijdsspanne: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1
Tijdsspanne: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12
Tijdsspanne: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Tijdsspanne: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Plasma Decay Half-Life (t1/2) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Tijdsspanne: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Apparent Volume of Distribution (Vz/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Tijdsspanne: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Apparent Oral Clearance (CL/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Tijdsspanne: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Minimum Observed Plasma Concentration (Cmin) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Tijdsspanne: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Peak:Trough ratio of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Tijdsspanne: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1
Tijdsspanne: 0, 1, 2, 3, 4, 6, 8, 12 hours post dose
0, 1, 2, 3, 4, 6, 8, 12 hours post dose
Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD
Tijdsspanne: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUCtau)) for PF-06427878 on day14 relative to day 1
Tijdsspanne: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Amount of PF-06427878 excreted in urine (Ae) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Tijdsspanne: 0- tau hours post dose
0- tau hours post dose
Percent of dose excreted in urine as PF-06427878 (Ae%) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Tijdsspanne: 0- tau hours post dose
0- tau hours post dose
Renal clearance of PF-06427878 (CLr) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Tijdsspanne: 0- tau hours post dose
0- tau hours post dose

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Pfizer

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 maart 2015

Primaire voltooiing (Werkelijk)

1 februari 2016

Studie voltooiing (Werkelijk)

1 februari 2016

Studieregistratiedata

Eerst ingediend

12 maart 2015

Eerst ingediend dat voldeed aan de QC-criteria

12 maart 2015

Eerst geplaatst (Schatting)

18 maart 2015

Updates van studierecords

Laatste update geplaatst (Schatting)

2 maart 2016

Laatste update ingediend die voldeed aan QC-criteria

1 maart 2016

Laatst geverifieerd

1 maart 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • B7871002
  • 2015-000130-29 (EudraCT-nummer)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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