A Single Oral Dose Study Of PF-06409577 In Healthy Adult Subjects
16. Juli 2015 aktualisiert von: 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.
Studienübersicht
Studientyp
Interventionell
Einschreibung (Tatsächlich)
39
Phase
- Phase 1
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
-
Brussels, Belgien, B-1070
- Pfizer Clinical Research Unit
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 55 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Cohort 1: 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
|
|
Experimental: 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
|
|
Experimental: 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
|
|
Experimental: 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
|
|
Experimental: 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
|
|
Experimental: 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
|
|
Experimental: 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
|
|
Experimental: 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
|
|
Experimental: 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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Number of Participants With Adverse Events (AEs)
Zeitfenster: 0-48 hours post dose
|
0-48 hours post dose
|
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Number of Participants With Laboratory Test Values of Potential Clinical Importance
Zeitfenster: 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
Zeitfenster: 0-48 hours post dose
|
0-48 hours post dose
|
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Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance
Zeitfenster: 0-48 hours post dose
|
0-48 hours post dose
|
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Number of Participants With Echocardiogram Findings of Potential Clinical Importance
Zeitfenster: 0-48 hours post dose
|
0-48 hours post dose
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Area Under the Curve From Time Zero to Time 24 hours (AUC24) for PF-06409577
Zeitfenster: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose
|
Area under the plasma concentration time-curve from zero to time 24 hours post dose (AUC24)
|
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose
|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06409577
Zeitfenster: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
|
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
|
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
Zeitfenster: 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).
|
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
Zeitfenster: 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
Zeitfenster: 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)
|
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
Zeitfenster: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
|
Plasma Decay Half-Life (t1/2)
|
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
Zeitfenster: 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.
|
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
Zeitfenster: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 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, 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)
Zeitfenster: 0-24 hours post dose
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Total amount of unchanged drug excreted in the urine over 24 hours.
|
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)
Zeitfenster: 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.
|
0-24 hours post dose
|
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Renal clearance for PF-06409577
Zeitfenster: 0-24 hours post dose
|
Renal clearance of a drug is a measure of the rate at which a drug is excreted unchanged into urine.
|
0-24 hours post dose
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. November 2014
Primärer Abschluss (Tatsächlich)
1. Juni 2015
Studienabschluss (Tatsächlich)
1. Juni 2015
Studienanmeldedaten
Zuerst eingereicht
6. November 2014
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
6. November 2014
Zuerst gepostet (Schätzen)
10. November 2014
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
20. Juli 2015
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
16. Juli 2015
Zuletzt verifiziert
1. Juli 2015
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- B7881001
- FIH (Andere Kennung: Alias Study Number)
- 2014-004022-18 (EudraCT-Nummer)
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