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A Study To Evaluate The Effect Of PF-04447943 On Qtc Interval In Healthy Adult Subjects

18. Juni 2018 aktualisiert von: Pfizer

A Phase 1, Single-dose, Randomized, 4-treatment, 4-period Crossover, Placebo- And Positive-controlled, Double-blind (Open-label For Positive Control), Sponsor-open Study To Determine The Effect Of PF-04447943 On Qtc Interval In Healthy Adult Subjects

This is a study designed to ascertain the effect of PF-04447943 on QT interval in healthy adult subjects. This is conducted as part of standard drug development.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

44

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

  • Vereinigte Staaten
    • Connecticut
      • New Haven, Connecticut, Vereinigte Staaten, 06511
        • Pfizer New Haven 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

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Healthy female subjects of non childbearing potential and/or healthy male subjects, between the ages of 18 and 55 years.
  • Body Mass Index (BMI) of 17.5 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 the time of dosing).
  • History of cerebrovascular accident, transient ischemic attack (TIA), or traumatic brain injury.
  • History of seizures or history or physical examination findings (eg localizing signs on neurologic examination) suggestive of structural central nervous system (CNS) abnormalities which may place patient at increased risk of seizures.
  • History of orthostatic blood pressure changes or clinically significant orthostatic symptoms.
  • Self reported history or risk factors for QT prolongation or torsades de pointes (eg, organic heart disease, congestive heart failure, hypokalemia, hypomagnesaemia, congenital long QT syndrome, myocardial ischemia or infarction), congenital deafness, family history of sudden death, and family history of long QT syndrome.

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: Crossover-Aufgabe
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: PF-04447943 low dose
25 mg of PF-04447943
Arzneimittel: PF-04447943
Single oral dose of PF-04447943 administered as an extemporaneously prepared solution
Experimental: PF-04447943 high dose
100 mg of PF-04447943
Arzneimittel: PF-04447943
Single oral dose of PF-04447943 administered as an extemporaneously prepared solution
Placebo-Komparator: Placebo
Matching placebo for PF-04447943
Arzneimittel: Placebo
Single oral dose of matching placebo for PF-04447943 administered as an extemporaneously prepared solution
Aktiver Komparator: Moxifloxacin
400 mg of moxifloxacin
Arzneimittel: Moxifloxacin
Single oral dose of moxifloxacin administered as tablet

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 0.5 Hour Post-Dose
Zeitfenster: 0.5 hour post-dose
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
0.5 hour post-dose
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 1 Hour Post-Dose
Zeitfenster: 1 hour post-dose
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
1 hour post-dose
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 2 Hours Post-Dose
Zeitfenster: 2 hours post-dose
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
2 hours post-dose
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 3 Hours Post-Dose
Zeitfenster: 3 hours post-dose
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
3 hours post-dose
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 4 Hours Post-Dose
Zeitfenster: 4 hours post-dose
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
4 hours post-dose
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 8 Hours Post-Dose
Zeitfenster: 8 hours post-dose
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
8 hours post-dose
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 12 Hours Post-Dose
Zeitfenster: 12 hours post-dose
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
12 hours post-dose
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 24 Hours Post-Dose
Zeitfenster: 24 hours post-dose
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
24 hours post-dose

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for Moxifloxacin and Placebo
Zeitfenster: 0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across Moxifloxacin and placebo is reported in statistical analysis.
0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose
Time-Matched Mean Difference in Heart Rate for PF-04447943 and Placebo
Zeitfenster: 0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose
Least square mean of heart rate measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose
Time-Matched Mean Difference in PR Interval for PF-04447943 and Placebo
Zeitfenster: 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
Least square mean of PR interval measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
Time-Matched Mean Difference in QRS Interval for PF-04447943 and Placebo
Zeitfenster: 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
Least square mean of QRS interval measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Zeitfenster: Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state.
Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days)
Number of Participants With Physical Examination Abnormalities
Zeitfenster: Baseline (Pre-dose)
Full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. Physical examination abnormalities were judged by the investigator.
Baseline (Pre-dose)
Number of Participants With Electrocardiogram (ECG) Abnormalities
Zeitfenster: Baseline up to 24 hours post-dose
Criteria for ECG abnormalities: maximum QTc corrected for heart rate using Bazett's formula (QTcB) and QTcF interval (450 to less than [<] 480 msec, 480 to <500 msec, greater than or equal to [>=] 500 msec; increase from baseline [IFB] >=30 msec and <60 msec, IFB >=60 msec). Baseline was defined as the average of the means obtained from the 3 sets of triplicate measurements taken at -1, -0.5 and 0 hours pre-dose on Day 1 within each intervention period.
Baseline up to 24 hours post-dose
Number of Participants With Vital Sign Abnormalities
Zeitfenster: Baseline (Pre-dose) up to 24 hours post-dose
Criteria for vital sign abnormalities: supine and standing pulse rate <40 bpm or greater than (>) 120 bpm, supine and standing systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine and standing diastolic blood pressure (DBP) <50 mmHg, maximum (max.) increase from baseline (IFB) and decrease from baseline (DFB) in supine and standing SBP of >=30 mmHg, maximum IFB and DFB in supine and Standing DBP of >=20 mmHg.
Baseline (Pre-dose) up to 24 hours post-dose
Number of Participants With Laboratory Test Abnormalities
Zeitfenster: Baseline (Pre-dose) up to 24 hours post-dose
Hemoglobin(Hgb), hematocrit, red blood cell(RBC)<0.8*lower limit of normal(LLN), mean corpuscular(MC) Hgb, MC volume <0.9*LLN, >1.1*upper limit of normal(ULN), platelet<0.5*LLN,>1.75*ULN, lymphocyte, neutrophil<0.8*LLN, >1.2*ULN, basophil, eosinophil, monocyte>1.2*ULN, white blood cell(WBC)<0.6*LLN,>1.5*ULN, reticulocytes<0.5*LLN,>1.5*ULN; bilirubin>1.5*ULN, aspartate aminotransferase(AT), alanine AT, alkaline phosphatase>3.0*ULN, protein, albumin<0.8*LLN,>1.2*ULN; blood urea nitrogen, creatinine>1.3*ULN, uric acid>1.2*ULN; sodium<0.95*LLN,>1.05*ULN, potassium, chloride, calcium, bicarbonate<0.9*LLN,>1.1*ULN; glucose<0.6*LLN, >1.5*ULN, HbA1c>1.3*ULN, creatinine kinase>2*ULN; urine-specific gravity<1.003,>1.030, pH<4.5,>8, WBC, RBC>=20, bacteria>20, urobilinogen, glucose, ketone, protein, Hgb, nitrite, leukocyte esterase, bilirubin>=1; thyroid stimulating hormone<0.8*LLN,>1.2*ULN; cholesterol, triglycerides>1.3*ULN, high density lipoprotein cholesterol(DL-C) <0.8*LLN, low DL-C>1.2*ULN.
Baseline (Pre-dose) up to 24 hours post-dose
Maximum Plasma Concentration (Cmax) of PF-04447943
Zeitfenster: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
Time of Observed Maximum Plasma Concentration (Tmax) of PF-04447943
Zeitfenster: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUClast) of PF-04447943
Zeitfenster: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
Area under the plasma concentration-time from time zero to time of last measurable concentration. Observed using the linear/log trapezoidal method.
Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Pfizer

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

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 (Tatsächlich)

29. Juni 2016

Primärer Abschluss (Tatsächlich)

20. Oktober 2016

Studienabschluss (Tatsächlich)

20. Oktober 2016

Studienanmeldedaten

Zuerst eingereicht

25. Mai 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. Mai 2016

Zuerst gepostet (Schätzen)

30. Mai 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. Dezember 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. Juni 2018

Zuletzt verifiziert

1. Juni 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • B0401018

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