A Single Oral Dose Study Of PF-06409577 In Healthy Adult Subjects
16. juli 2015 oppdatert av: Pfizer
A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Ascending Oral Doses Of Pf-06409577 In Healthy Adult Subjects
PF-06409577 is a new compound proposed for the treatment of diabetic nephropathy.
The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single oral doses of PF-06409577 in healthy adult subjects.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
39
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 male, 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
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
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: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Cohort 1: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
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PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
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Eksperimentell: Cohort 2: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
|
PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
|
|
Eksperimentell: Cohort 3: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
|
PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
|
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Eksperimentell: Cohort 4: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
|
PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
|
|
Eksperimentell: Cohort 5: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
|
PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
|
|
Eksperimentell: Cohort 6: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
|
PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
|
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Eksperimentell: Cohort 7: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
|
PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
|
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Eksperimentell: Cohort 8: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
|
PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
|
|
Eksperimentell: Cohort 9: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
|
PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Number of Participants With Adverse Events (AEs)
Tidsramme: 0-48 hours post dose
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0-48 hours post dose
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Number of Participants With Laboratory Test Values of Potential Clinical Importance
Tidsramme: 0-48 hours post dose
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0-48 hours post dose
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Number of Participants With Vital Signs Findings (Including Bood Pressure and Pulse Rate) of Potential Clinical Importance
Tidsramme: 0-48 hours post dose
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0-48 hours post dose
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Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance
Tidsramme: 0-48 hours post dose
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0-48 hours post dose
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Number of Participants With Echocardiogram Findings of Potential Clinical Importance
Tidsramme: 0-48 hours post dose
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0-48 hours post dose
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Area Under the Curve From Time Zero to Time 24 hours (AUC24) for PF-06409577
Tidsramme: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose
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Area under the plasma concentration time-curve from zero to time 24 hours post dose (AUC24)
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0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06409577
Tidsramme: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
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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, 12, 16, 24, 36, 48 hours post dose
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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] for PF-06409577
Tidsramme: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 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).
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0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
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Maximum Observed Plasma Concentration (Cmax) for PF-06409577
Tidsramme: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
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Maximum Observed Plasma Concentration (Cmax)
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0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06409577
Tidsramme: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 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, 12, 16, 24, 36, 48 hours post dose
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Plasma Decay Half-Life (t1/2) for PF-06409577
Tidsramme: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
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Plasma Decay Half-Life (t1/2)
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0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
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Apparent Oral Clearance (CL/F) for PF-06409577
Tidsramme: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 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 oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
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0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
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Apparent Volume of Distribution (Vz/F) for PF-06409577
Tidsramme: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
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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, 12, 16, 24, 36, 48 hours post dose
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Total amount of PF-06409577 excreted in the urine over 24 hours (Ae24)
Tidsramme: 0-24 hours post dose
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Total amount of unchanged drug excreted in the urine over 24 hours.
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0-24 hours post dose
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Total amount of PF-06409577 excreted in the urine over 24 hours, expressed as percent of dose (%Ae24)
Tidsramme: 0-24 hours post dose
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Total amount of unchanged drug excreted in the urine over 24 hours, expressed as percent of dose.
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0-24 hours post dose
|
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Renal clearance for PF-06409577
Tidsramme: 0-24 hours post dose
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Renal clearance of a drug is a measure of the rate at which a drug is excreted unchanged into urine.
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0-24 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
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
1. november 2014
Primær fullføring (Faktiske)
1. juni 2015
Studiet fullført (Faktiske)
1. juni 2015
Datoer for studieregistrering
Først innsendt
6. november 2014
Først innsendt som oppfylte QC-kriteriene
6. november 2014
Først lagt ut (Anslag)
10. november 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
20. juli 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. juli 2015
Sist bekreftet
1. juli 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- B7881001
- FIH (Annen identifikator: Alias Study Number)
- 2014-004022-18 (EudraCT-nummer)
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. .