A Study To Evaluate The Effect Of PF-04447943 On Qtc Interval In Healthy Adult Subjects
18 juni 2018 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
44
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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Connecticut
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New Haven, Connecticut, Verenigde Staten, 06511
- Pfizer New Haven 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
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
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: Crossover-opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: PF-04447943 low dose
25 mg of PF-04447943
|
Single oral dose of PF-04447943 administered as an extemporaneously prepared solution
|
|
Experimenteel: PF-04447943 high dose
100 mg of PF-04447943
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Single oral dose of PF-04447943 administered as an extemporaneously prepared solution
|
|
Placebo-vergelijker: Placebo
Matching placebo for PF-04447943
|
Single oral dose of matching placebo for PF-04447943 administered as an extemporaneously prepared solution
|
|
Actieve vergelijker: Moxifloxacin
400 mg of moxifloxacin
|
Single oral dose of moxifloxacin administered as tablet
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for Moxifloxacin and Placebo
Tijdsspanne: 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
|
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Time-Matched Mean Difference in Heart Rate for PF-04447943 and Placebo
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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.
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Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days)
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Number of Participants With Physical Examination Abnormalities
Tijdsspanne: 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.
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Baseline (Pre-dose)
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Number of Participants With Electrocardiogram (ECG) Abnormalities
Tijdsspanne: Baseline up to 24 hours post-dose
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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
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Number of Participants With Vital Sign Abnormalities
Tijdsspanne: 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
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Number of Participants With Laboratory Test Abnormalities
Tijdsspanne: 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
|
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Maximum Plasma Concentration (Cmax) of PF-04447943
Tijdsspanne: 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
|
|
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Time of Observed Maximum Plasma Concentration (Tmax) of PF-04447943
Tijdsspanne: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
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Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
|
|
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Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUClast) of PF-04447943
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
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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 (Werkelijk)
29 juni 2016
Primaire voltooiing (Werkelijk)
20 oktober 2016
Studie voltooiing (Werkelijk)
20 oktober 2016
Studieregistratiedata
Eerst ingediend
25 mei 2016
Eerst ingediend dat voldeed aan de QC-criteria
25 mei 2016
Eerst geplaatst (Schatting)
30 mei 2016
Updates van studierecords
Laatste update geplaatst (Werkelijk)
28 december 2018
Laatste update ingediend die voldeed aan QC-criteria
18 juni 2018
Laatst geverifieerd
1 juni 2018
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- B0401018
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 .
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