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- Klinische proef NCT02079922
A Multiple Dose Study Of PF-06678552 In Healthy Subjects
29 juli 2014 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
38
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
-
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Brussels, België, B-1070
- Pfizer Investigational Site
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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 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)
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
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 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.
|
Experimenteel: 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.
|
Experimenteel: 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.
|
Experimenteel: 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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Experimenteel: 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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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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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.
Tijdsspanne: 0 to 24 days post dose
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0 to 24 days post dose
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 1
Tijdsspanne: 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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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 7
Tijdsspanne: 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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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 14
Tijdsspanne: 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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Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 1
Tijdsspanne: 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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Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 7
Tijdsspanne: 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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Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 14
Tijdsspanne: 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
Tijdsspanne: 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 7
Tijdsspanne: 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 14
Tijdsspanne: 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
Tijdsspanne: 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 7
Tijdsspanne: 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 14
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06644927 on day 14 relative to day 1
Tijdsspanne: 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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Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06644927 on day 7 relative to day 1
Tijdsspanne: 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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Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06644927 on day 14 relative to day 1
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 on day 7
Tijdsspanne: 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
|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 on day 14
Tijdsspanne: 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
|
|
Area Under the Curve during the dosing interval (AUCtau) for PF-06678552 on day 1
Tijdsspanne: 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
|
|
Area Under the Curve during the dosing interval (AUCtau) for PF-06678552 on day 7
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Apparent Oral Clearance (CL/F) of PF-06678552 on day 7
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
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.
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 2014
Primaire voltooiing (Werkelijk)
1 juli 2014
Studie voltooiing (Werkelijk)
1 juli 2014
Studieregistratiedata
Eerst ingediend
4 maart 2014
Eerst ingediend dat voldeed aan de QC-criteria
4 maart 2014
Eerst geplaatst (Schatting)
6 maart 2014
Updates van studierecords
Laatste update geplaatst (Schatting)
31 juli 2014
Laatste update ingediend die voldeed aan QC-criteria
29 juli 2014
Laatst geverifieerd
1 juli 2014
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- B7611002
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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