A Multiple Dose Study Of PF-06678552 In Healthy Subjects
29. juli 2014 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
38
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Brussels, Belgien, B-1070
- Pfizer Investigational Site
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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.
- 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)
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: Cohort 1
Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
|
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
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.
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.
|
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Eksperimentel: Cohort 2
Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
|
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
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.
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.
|
|
Eksperimentel: Cohort 3
Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
|
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
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.
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.
|
|
Eksperimentel: Cohort 4
Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
|
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
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.
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.
|
|
Eksperimentel: 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.
|
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
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.
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.
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|
Eksperimentel: 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.
|
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
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.
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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.
Tidsramme: 0 to 24 days post dose
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0 to 24 days post dose
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 1
Tidsramme: 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
|
|
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 7
Tidsramme: 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
|
|
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 14
Tidsramme: 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
|
|
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Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 1
Tidsramme: 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
|
|
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Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 7
Tidsramme: 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
Tidsramme: 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
|
|
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Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 1
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
|
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 on day 1
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
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Amount of PF-06644927 excreted in urine (Ae) on day 14
Tidsramme: 0-12 hours post dose
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0-12 hours post dose
|
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Percent of dose excreted in urine as PF-06644927 (Ae%) on day 14
Tidsramme: 0-12 hours post dose
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0-12 hours post dose
|
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Renal clearance of PF-06644927 (CLr) on day 14
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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.
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. marts 2014
Primær færdiggørelse (Faktiske)
1. juli 2014
Studieafslutning (Faktiske)
1. juli 2014
Datoer for studieregistrering
Først indsendt
4. marts 2014
Først indsendt, der opfyldte QC-kriterier
4. marts 2014
Først opslået (Skøn)
6. marts 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
31. juli 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. juli 2014
Sidst verificeret
1. juli 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- B7611002
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 .
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