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A Multiple Dose Study Of PF-06678552 In Healthy Subjects

29 luglio 2014 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

38

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 55 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Cohort 1
Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Droga: PF-06678552
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
Droga: Placebo
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
Droga: 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.
Droga: 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.
Sperimentale: Cohort 2
Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Droga: PF-06678552
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
Droga: Placebo
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
Droga: 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.
Droga: 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.
Sperimentale: Cohort 3
Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Droga: PF-06678552
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
Droga: Placebo
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
Droga: 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.
Droga: 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.
Sperimentale: Cohort 4
Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Droga: PF-06678552
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
Droga: Placebo
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
Droga: 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.
Droga: 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.
Sperimentale: 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.
Droga: PF-06678552
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
Droga: Placebo
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
Droga: 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.
Droga: 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.
Sperimentale: 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.
Droga: PF-06678552
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
Droga: Placebo
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
Droga: 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.
Droga: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
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.
Lasso di tempo: 0 to 24 days post dose
0 to 24 days post dose

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 1
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 0-12 hours post dose
0-12 hours post dose
Percent of dose excreted in urine as PF-06644927 (Ae%) on day 14
Lasso di tempo: 0-12 hours post dose
0-12 hours post dose
Renal clearance of PF-06644927 (CLr) on day 14
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2014

Completamento primario (Effettivo)

1 luglio 2014

Completamento dello studio (Effettivo)

1 luglio 2014

Date di iscrizione allo studio

Primo inviato

4 marzo 2014

Primo inviato che soddisfa i criteri di controllo qualità

4 marzo 2014

Primo Inserito (Stima)

6 marzo 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

31 luglio 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 luglio 2014

Ultimo verificato

1 luglio 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • B7611002

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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