A Multiple Dose Study Of PF-06678552 In Healthy Subjects
29 lipca 2014 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
38
Faza
- Faza 1
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Brussels, Belgia, B-1070
- Pfizer Investigational Site
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat do 55 lat (Dorosły)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Opis
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)
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Cohort 1
Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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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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Eksperymentalny: 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.
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Eksperymentalny: Cohort 3
Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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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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Eksperymentalny: 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.
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Eksperymentalny: 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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Eksperymentalny: 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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
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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.
Ramy czasowe: 0 to 24 days post dose
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0 to 24 days post dose
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 1
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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 14
Ramy czasowe: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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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
Ramy czasowe: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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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
Ramy czasowe: 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
Ramy czasowe: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
|
|
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Plasma Decay Half-Life (t1/2) for PF-06644927 on day 14
Ramy czasowe: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose
|
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Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06644927 on day 7 relative to day 1
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06644927 on day 14 relative to day 1
Ramy czasowe: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 0-12 hours post dose
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0-12 hours post dose
|
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 on day 1
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
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Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 marca 2014
Zakończenie podstawowe (Rzeczywisty)
1 lipca 2014
Ukończenie studiów (Rzeczywisty)
1 lipca 2014
Daty rejestracji na studia
Pierwszy przesłany
4 marca 2014
Pierwszy przesłany, który spełnia kryteria kontroli jakości
4 marca 2014
Pierwszy wysłany (Oszacować)
6 marca 2014
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
31 lipca 2014
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
29 lipca 2014
Ostatnia weryfikacja
1 lipca 2014
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- B7611002
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .