A Single Oral Dose Study Of PF-06409577 In Healthy Adult Subjects
16 juli 2015 bijgewerkt door: 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.
Studie Overzicht
Studietype
Ingrijpend
Inschrijving (Werkelijk)
39
Fase
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Brussels, België, B-1070
- Pfizer Clinical Research Unit
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 55 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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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Experimenteel: Cohort 2: 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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Experimenteel: Cohort 3: 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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Experimenteel: 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
|
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Experimenteel: 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
|
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Experimenteel: 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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Experimenteel: Cohort 7: 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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Experimenteel: 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
|
|
Experimenteel: 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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Number of Participants With Adverse Events (AEs)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 0-48 hours post dose
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0-48 hours post dose
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Area Under the Curve From Time Zero to Time 24 hours (AUC24) for PF-06409577
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
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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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
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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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 november 2014
Primaire voltooiing (Werkelijk)
1 juni 2015
Studie voltooiing (Werkelijk)
1 juni 2015
Studieregistratiedata
Eerst ingediend
6 november 2014
Eerst ingediend dat voldeed aan de QC-criteria
6 november 2014
Eerst geplaatst (Schatting)
10 november 2014
Updates van studierecords
Laatste update geplaatst (Schatting)
20 juli 2015
Laatste update ingediend die voldeed aan QC-criteria
16 juli 2015
Laatst geverifieerd
1 juli 2015
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- B7881001
- FIH (Andere identificatie: Alias Study Number)
- 2014-004022-18 (EudraCT-nummer)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .