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A Multiple Dose Study Of PF-06678552 In Healthy Subjects

29. Juli 2014 aktualisiert von: Pfizer

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PF-06678552 After Administration Of Multiple Escalating Oral Doses In Healthy Adult Subjects

PF-06678552 is a new compound proposed for the treatment of hypercholesteremia. The primary purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of PF-06678552 in healthy subjects.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

38

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Belgien
      • Brussels, Belgien, B-1070
        • Pfizer Investigational Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 55 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Healthy male and/or female subjects of non-childbearing potential.
  • Body Mass Index (BMI) of 18 to 30.5 kg/m2; and a total body weight >50 kg
  • Low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Cohort 1
Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Arzneimittel: PF-06678552
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
Arzneimittel: Placebo
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
Arzneimittel: PF-06678552
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
Arzneimittel: Placebo
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
Experimental: Cohort 2
Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Arzneimittel: PF-06678552
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
Arzneimittel: Placebo
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
Arzneimittel: PF-06678552
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
Arzneimittel: Placebo
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
Experimental: Cohort 3
Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Arzneimittel: PF-06678552
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
Arzneimittel: Placebo
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
Arzneimittel: PF-06678552
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
Arzneimittel: Placebo
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
Experimental: Cohort 4
Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Arzneimittel: PF-06678552
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
Arzneimittel: Placebo
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
Arzneimittel: PF-06678552
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
Arzneimittel: Placebo
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
Experimental: Cohort 5
Single dose level of PF-06678552 or placebo will be provided either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Arzneimittel: PF-06678552
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
Arzneimittel: Placebo
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
Arzneimittel: PF-06678552
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
Arzneimittel: Placebo
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
Experimental: Cohort 6
Single dose level of PF-06678552 or placebo will be provided either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Arzneimittel: PF-06678552
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
Arzneimittel: Placebo
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
Arzneimittel: PF-06678552
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
Arzneimittel: Placebo
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate), and cardiac conduction intervals as assessed by 12 lead ECG.
Zeitfenster: 0 to 24 days post dose
0 to 24 days post dose

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 1
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 7
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 14
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 1
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 7
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 14
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 1
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 7
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 14
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 on day 1
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 on day 7
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 on day 14
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Plasma Decay Half-Life (t1/2) for PF-06644927 on day 14
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose
Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06644927 on day 7 relative to day 1
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06644927 on day 14 relative to day 1
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06644927 on day 7 relative to day 1
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06644927 on day 14 relative to day 1
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Amount of PF-06644927 excreted in urine (Ae) on day 14
Zeitfenster: 0-12 hours post dose
0-12 hours post dose
Percent of dose excreted in urine as PF-06644927 (Ae%) on day 14
Zeitfenster: 0-12 hours post dose
0-12 hours post dose
Renal clearance of PF-06644927 (CLr) on day 14
Zeitfenster: 0-12 hours post dose
0-12 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 on day 1
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 on day 7
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 on day 14
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Area Under the Curve during the dosing interval (AUCtau) for PF-06678552 on day 1
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Area Under the Curve during the dosing interval (AUCtau) for PF-06678552 on day 7
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Area Under the Curve during the dosing interval (AUCtau) for PF-06678552 on day 14
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 1
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 7
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 14
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06678552 on day 1
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06678552 on day 7
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Plasma Decay Half-Life (t1/2) for PF-06678552 on day 14
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose
Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06678552 on day 7 relative to day 1
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06678552 on day 14 relative to day 1
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06678552 on day 7 relative to day 1
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06678552 on day 14 relative to day 1
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Apparent Oral Clearance (CL/F) of PF-06678552 on day 7
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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.
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Apparent Oral Clearance (CL/F) of PF-06678552 on day 14
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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.
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Apparent Volume of Distribution (Vz/F) of PF-06678552 on day 7
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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.
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Apparent Volume of Distribution (Vz/F) of PF-06678552 on day 14
Zeitfenster: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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.
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Pfizer

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. März 2014

Primärer Abschluss (Tatsächlich)

1. Juli 2014

Studienabschluss (Tatsächlich)

1. Juli 2014

Studienanmeldedaten

Zuerst eingereicht

4. März 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. März 2014

Zuerst gepostet (Schätzen)

6. März 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

31. Juli 2014

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Juli 2014

Zuletzt verifiziert

1. Juli 2014

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • B7611002

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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