First in Human Study for PF-06667272
17. oktober 2017 oppdatert av: Pfizer
A Phase 1, Randomized, Double-blind (Sponsor-open), Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06667272 Under Fed And Fasted Conditions, In Healthy Adult Subjects
The current study is the first clinical trial proposed with PF-06667272.
It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single ascending doses of PF-06667272 under fed and fasted conditions, in healthy adult subjects.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
16
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
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Brussels, Belgia, B-1070
- Pfizer Clinical Research Unit
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 55 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Healthy males and female of non-childbearing potential;
- Body Mass Index 17.5-30.5 kg/m2;
- Body weight >50 kg;
Exclusion Criteria:
- Evidence of 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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Cohort 1_Period 1_Active
Single ascending dose of PF-06667272
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Single ascending dose of PF-06667272
|
|
Placebo komparator: Cohort 1_Period 1_Placebo
Single dose of placebo
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Single dose of placebo
|
|
Eksperimentell: Cohort 1_Period 2_Active
Single ascending dose of PF-06667272
|
Single ascending dose of PF-06667272
|
|
Placebo komparator: Cohort 1_Period 2_Placebo
Single dose of placebo
|
Single dose of placebo
|
|
Eksperimentell: Cohort 1_Period 3_Active
Single ascending dose of PF-06667272
|
Single ascending dose of PF-06667272
|
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Placebo komparator: Cohort 1_Period 3_Placebo
Single dose of placebo
|
Single dose of placebo
|
|
Eksperimentell: Cohrot 1_Period 4_Active
Single ascending dose of PF-06667272
|
Single ascending dose of PF-06667272
|
|
Placebo komparator: Cohort 1_Period 4_Placebo
Single dose of placebo
|
Single dose of placebo
|
|
Eksperimentell: Cohort 2_Period 1_Active
Single ascending dose of PF-06667272
|
Single ascending dose of PF-06667272
|
|
Placebo komparator: Cohort 2_Period 1_Placebo
Single dose of placebo
|
Single dose of placebo
|
|
Eksperimentell: Cohort 2_Period 2_Active
Single ascending dose of PF-06667272
|
Single ascending dose of PF-06667272
|
|
Placebo komparator: Cohort 2_Period 2_Placebo
Single dose of placebo
|
Single dose of placebo
|
|
Eksperimentell: Cohort 2_Period 3_Active
Single ascending dose of PF-06667272
|
Single ascending dose of PF-06667272
|
|
Placebo komparator: Cohort 2_Period 3_Placebo
Single dose of placebo
|
Single dose of placebo
|
|
Eksperimentell: Cohort 2_Period 4_Active
Single ascending dose of PF-06667272
|
Single ascending dose of PF-06667272
|
|
Placebo komparator: Cohort 2_Period 4_Placebo
Single dose of placebo
|
Single dose of placebo
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs) or other safety concerns
Tidsramme: Baseline (Day 1, hour 0) up to 28 days after last dose of study medication
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Assessment by adverse event monitoring, 12 lead ECGs, telemetry, vital signs and clinical safety laboratory measurements. Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category. |
Baseline (Day 1, hour 0) up to 28 days after last dose of study medication
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06667272 and PF-06818073
Tidsramme: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
|
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
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0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-06667272 and PF-06818073 (as permitted)
Tidsramme: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
|
AUC (0-infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-infinity).
It is obtained from AUC (0-t) plus AUC (t-infinity).
|
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
|
|
Maximum Observed Plasma Concentration (Cmax) for PF-06667272 and PF-06818073
Tidsramme: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
|
Maximum Observed Plasma Concentration (Cmax)
|
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
|
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Time to Reach Maximum Observed Concentration for PF-06667272 and PF-06818073
Tidsramme: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
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Time to Reach Maximum Observed Plasma Concentration (Tmax)
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0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
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Plasma Decay Half-Life (t1/2) for PF-06667272 and PF-06818073
Tidsramme: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
|
Plasma Decay Half-Life (t1/2)
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0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
|
|
Apparent Total Body Clearance (CL/F) for PF-06667272
Tidsramme: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 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 apparent total body 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, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
|
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Apparent Volume of Distribution (Vz/F) for PF-06667272
Tidsramme: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 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.
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0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
11. mai 2017
Primær fullføring (Faktiske)
5. september 2017
Studiet fullført (Faktiske)
5. september 2017
Datoer for studieregistrering
Først innsendt
19. april 2017
Først innsendt som oppfylte QC-kriteriene
19. april 2017
Først lagt ut (Faktiske)
24. april 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. oktober 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. oktober 2017
Sist bekreftet
1. oktober 2017
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- C0231002
- 2017-000590-36 (EudraCT-nummer)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
IPD-planbeskrivelse
Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Ja
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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