A Study in Normal Healthy People, Testing Different Versions of a Pill That Will be Used to Treat Rheumatoid Arthritis.
10. oktober 2009 opdateret af: Pfizer
An Open-Label Two-Part Randomized, Crossover Study Of The Pharmacokinetics Of CE-224,535 Administered As Controlled And Immediate Release Formulations In Healthy Volunteers
The study will try, in 2 separate parts, each using 12 research subjects, to see how a new form of the pill CE 224,535 gets released into the bloodstream and whether that is affected by food.
In each part, subjects will switch among 4 treatment periods to take either different forms of the pill(s) or the same form either after fasting or eating a meal.
The second part will only happen depending on whether the sponsor believes it is needed and will use separate subject than the first part.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
11
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Connecticut
-
New Haven, Connecticut, Forenede Stater, 06511
- Pfizer Investigational Site
-
-
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:
- aged 18-55 and healthy
Exclusion Criteria:
- severe chronic or uncontrolled medical or psychiatric conditions, including drug abuse
- pregnant or wanting to become pregnant
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Part1; controlled release formulation 4; 250 mg
one 250 mg controlled release tablet, once in the morning, in fasted state
|
one 250mg tablet, once in the morning in fasted state
Andre navne:
2x250 mg tablets, once in the morning, in fasted state
Andre navne:
4x250mg tablets, once in the morning, in fasted state
Andre navne:
2x250mg tab, once in the morning, after being fed a high fat meal
Andre navne:
4x125 mg tabs, once in the morning, in the fasted state.
This arm will only occur as part of Part 2, if needed, pending results of Part 1.
Andre navne:
4x125 mg IR once in the morning after being fed a high fat meal
Andre navne:
|
|
Eksperimentel: Part1; controlled release formulation 4; 500 mg
2x250 mg, once in the morning, in fasted state
|
one 250mg tablet, once in the morning in fasted state
Andre navne:
2x250 mg tablets, once in the morning, in fasted state
Andre navne:
4x250mg tablets, once in the morning, in fasted state
Andre navne:
2x250mg tab, once in the morning, after being fed a high fat meal
Andre navne:
4x125 mg tabs, once in the morning, in the fasted state.
This arm will only occur as part of Part 2, if needed, pending results of Part 1.
Andre navne:
4x125 mg IR once in the morning after being fed a high fat meal
Andre navne:
|
|
Eksperimentel: Part 1; controlled release formula 4; 1000 mg
4x250 mg tabs, once in the morning, in fasted state
|
one 250mg tablet, once in the morning in fasted state
Andre navne:
2x250 mg tablets, once in the morning, in fasted state
Andre navne:
4x250mg tablets, once in the morning, in fasted state
Andre navne:
2x250mg tab, once in the morning, after being fed a high fat meal
Andre navne:
4x125 mg tabs, once in the morning, in the fasted state.
This arm will only occur as part of Part 2, if needed, pending results of Part 1.
Andre navne:
4x125 mg IR once in the morning after being fed a high fat meal
Andre navne:
|
|
Eksperimentel: Part 1; controlled release formulation 4; 500 mg FED
2x250 mg, once in the morning , in fed state
|
one 250mg tablet, once in the morning in fasted state
Andre navne:
2x250 mg tablets, once in the morning, in fasted state
Andre navne:
4x250mg tablets, once in the morning, in fasted state
Andre navne:
2x250mg tab, once in the morning, after being fed a high fat meal
Andre navne:
4x125 mg tabs, once in the morning, in the fasted state.
This arm will only occur as part of Part 2, if needed, pending results of Part 1.
Andre navne:
4x125 mg IR once in the morning after being fed a high fat meal
Andre navne:
|
|
Eksperimentel: Part 2; IR formulation 500mg
4x125 mg tab of current formulation , once in the morning in the fasted state.
This arm will occur as Part 2, only as needed, pending results of Part 1
|
one 250mg tablet, once in the morning in fasted state
Andre navne:
2x250 mg tablets, once in the morning, in fasted state
Andre navne:
4x250mg tablets, once in the morning, in fasted state
Andre navne:
2x250mg tab, once in the morning, after being fed a high fat meal
Andre navne:
4x125 mg tabs, once in the morning, in the fasted state.
This arm will only occur as part of Part 2, if needed, pending results of Part 1.
Andre navne:
4x125 mg IR once in the morning after being fed a high fat meal
Andre navne:
|
|
Eksperimentel: Part 2; IR formulation, 500 mg FED
4x125 mg once in the morning in the fed state.
This arm will occur as part of Part 2,only as needed, pending results of Part 1.
|
one 250mg tablet, once in the morning in fasted state
Andre navne:
2x250 mg tablets, once in the morning, in fasted state
Andre navne:
4x250mg tablets, once in the morning, in fasted state
Andre navne:
2x250mg tab, once in the morning, after being fed a high fat meal
Andre navne:
4x125 mg tabs, once in the morning, in the fasted state.
This arm will only occur as part of Part 2, if needed, pending results of Part 1.
Andre navne:
4x125 mg IR once in the morning after being fed a high fat meal
Andre navne:
|
|
Eksperimentel: Part 2; controlled release formulation 5;500 mg, FASTED
2x250 controlled release formulation 5 tabs once in the morning in the fasted state.
This arm will only occur as part of Part 2, pending results of Part 1.
|
2x250 mg controlled release formulation 5 tabs once in the morning in the fasted state
Andre navne:
2x250 mg controlled release formulation 5 once in the morning after being fed a high fat meal
Andre navne:
|
|
Eksperimentel: Part 2; controlled release formulation 5;500 mg, FED
2x250 mg controlled release formulation 5 tabs once in the morning in the fed state.
This arm will only occur as part of Part 2 pending results of Part 1
|
2x250 mg controlled release formulation 5 tabs once in the morning in the fasted state
Andre navne:
2x250 mg controlled release formulation 5 once in the morning after being fed a high fat meal
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
pharmacokinetic parameters: Tmax, Cmax, AUClast, AUC(0-00), C24, t1/2
Tidsramme: 48 hrs
|
48 hrs
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
safety parameters including: renal and liver function, blood counts, electrolytes, ECG, and pregnancy testing
Tidsramme: 48 hrs
|
48 hrs
|
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. januar 2009
Primær færdiggørelse (Faktiske)
1. marts 2009
Studieafslutning (Faktiske)
1. marts 2009
Datoer for studieregistrering
Først indsendt
2. februar 2009
Først indsendt, der opfyldte QC-kriterier
5. februar 2009
Først opslået (Skøn)
6. februar 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
14. oktober 2009
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. oktober 2009
Sidst verificeret
1. oktober 2009
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- A6341012
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 .