A Multiple Oral Doses Study Of PF-06427878 In Healthy Adult Subjects
1 mars 2016 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
40
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Brussels, Belgien, B-1070
- Pfizer Clinical Research Unit
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 55 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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).
|
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Experimentell: 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).
|
|
Experimentell: 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).
|
|
Experimentell: 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).
|
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Experimentell: 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).
|
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Experimentell: 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.
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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).
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Assessment of adverse events (AEs).
Tidsram: 0-25 days
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0-25 days
|
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Assessment of clinical laboratory tests.
Tidsram: 0-25 days
|
0-25 days
|
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Assessment of vital signs (including blood pressure and pulse rate).
Tidsram: 0-25 days
|
0-25 days
|
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Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG).
Tidsram: 0-25 days
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0-25 days
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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 14
Tidsram: 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
Tidsram: 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 12
Tidsram: 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
Tidsram: 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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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
Tidsram: 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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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
Tidsram: 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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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
Tidsram: 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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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
Tidsram: 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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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
Tidsram: 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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Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1
Tidsram: 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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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
Tidsram: 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 Area Under the Curve during the dosing interval (Rac(AUCtau)) for PF-06427878 on day14 relative to day 1
Tidsram: 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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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
Tidsram: 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
Tidsram: 0- tau hours post dose
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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
Tidsram: 0- tau hours post dose
|
0- tau hours post dose
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Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2015
Primärt slutförande (Faktisk)
1 februari 2016
Avslutad studie (Faktisk)
1 februari 2016
Studieregistreringsdatum
Först inskickad
12 mars 2015
Först inskickad som uppfyllde QC-kriterierna
12 mars 2015
Första postat (Uppskatta)
18 mars 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
2 mars 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 mars 2016
Senast verifierad
1 mars 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- B7871002
- 2015-000130-29 (EudraCT-nummer)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .