A Multiple Oral Doses Study Of PF-06427878 In Healthy Adult Subjects
1. marts 2016 opdateret af: Pfizer
A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Multiple Escalating Oral Doses Of Pf-06427878 Co Administered With And Without Food In Healthy Adult Subjects
PF-06427878 is a new compound proposed for the treatment of hyperlipidemia.
The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple oral doses of PF-06427878 in healthy adult subjects.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
40
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 Clinical Research Unit
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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 17.5 to 35.4 kg/m2; and a total body weight >50 kg
- Subjects with fasting TG level of >=90 mg/dL and <=500 mg/dL following an overnight fast
- Subjects with low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL following an overnight fast
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
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Cohort 1
Single dose level of PF-06427878 at 5 mg or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
|
|
Eksperimentel: Cohort 2
Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 1 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
|
PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
|
|
Eksperimentel: Cohort 3
Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 2 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
|
PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
|
|
Eksperimentel: Cohort 4
Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 3 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
|
PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
|
|
Eksperimentel: Cohort 5
Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 4 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
|
PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
|
|
Eksperimentel: Cohort 6
Single dose level of PF-06427878 (with the same total daily dose as Cohort 5) or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
|
PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Assessment of adverse events (AEs).
Tidsramme: 0-25 days
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0-25 days
|
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Assessment of clinical laboratory tests.
Tidsramme: 0-25 days
|
0-25 days
|
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Assessment of vital signs (including blood pressure and pulse rate).
Tidsramme: 0-25 days
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0-25 days
|
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Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG).
Tidsramme: 0-25 days
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0-25 days
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Maximum Observed Plasma Concentration (Cmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1
Tidsramme: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
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Maximum Observed Plasma Concentration (Cmax) for PF-06427878during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12
Tidsramme: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
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Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 14
Tidsramme: 0, 1, 2, 3, 4, 6, 8, 12 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12 hours post dose
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1
Tidsramme: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12
Tidsramme: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Tidsramme: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
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Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1
Tidsramme: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
|
Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12
Tidsramme: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
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Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Tidsramme: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Plasma Decay Half-Life (t1/2) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Tidsramme: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
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Apparent Volume of Distribution (Vz/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Tidsramme: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Apparent Oral Clearance (CL/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Tidsramme: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
|
Minimum Observed Plasma Concentration (Cmin) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Tidsramme: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
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Peak:Trough ratio of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Tidsramme: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
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Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1
Tidsramme: 0, 1, 2, 3, 4, 6, 8, 12 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12 hours post dose
|
|
Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD
Tidsramme: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
|
Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUCtau)) for PF-06427878 on day14 relative to day 1
Tidsramme: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
|
0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Amount of PF-06427878 excreted in urine (Ae) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Tidsramme: 0- tau hours post dose
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0- tau hours post dose
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Percent of dose excreted in urine as PF-06427878 (Ae%) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Tidsramme: 0- tau hours post dose
|
0- tau hours post dose
|
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Renal clearance of PF-06427878 (CLr) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Tidsramme: 0- tau hours post dose
|
0- tau 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 2015
Primær færdiggørelse (Faktiske)
1. februar 2016
Studieafslutning (Faktiske)
1. februar 2016
Datoer for studieregistrering
Først indsendt
12. marts 2015
Først indsendt, der opfyldte QC-kriterier
12. marts 2015
Først opslået (Skøn)
18. marts 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
2. marts 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. marts 2016
Sidst verificeret
1. marts 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- B7871002
- 2015-000130-29 (EudraCT nummer)
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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