HealthyPhase 1NCT02785770

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

A Phase 1 study testing PF-04447943 and Moxifloxacin in people with Healthy, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: PF-04447943 and Moxifloxacin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 44 participants
Where: 1 siteUnited States
Study dates: 29 Jun 2016to 20 Oct 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: 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.

Conditions: Healthy
Being tested: PF-04447943, Placebo, Moxifloxacin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-04447943Drug
Single oral dose of PF-04447943 administered as an extemporaneously prepared solution
PlaceboDrug
Single oral dose of matching placebo for PF-04447943 administered as an extemporaneously prepared solution
MoxifloxacinDrug
Single oral dose of moxifloxacin administered as tablet

Study groups in NCT02785770
Study group	Role	What they receive
PF-04447943 low dose	Experimental	25 mg of PF-04447943 Receives: Drug: PF-04447943
PF-04447943 high dose	Experimental	100 mg of PF-04447943 Receives: Drug: PF-04447943
Placebo	Placebo comparator	Matching placebo for PF-04447943 Receives: Drug: Placebo
Moxifloxacin	Active comparator	400 mg of moxifloxacin Receives: Drug: Moxifloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 24 hours post-dose

Secondary outcomes (12)

Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for Moxifloxacin and Placebo
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
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.
Measured: Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days)
Number of Participants With Physical Examination Abnormalities
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.
Measured: Baseline (Pre-dose)
Number of Participants With Electrocardiogram (ECG) Abnormalities
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.
Measured: Baseline up to 24 hours post-dose
Number of Participants With Vital Sign Abnormalities
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.
Measured: Baseline (Pre-dose) up to 24 hours post-dose
Number of Participants With Laboratory Test Abnormalities
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.
Measured: Baseline (Pre-dose) up to 24 hours post-dose
Maximum Plasma Concentration (Cmax) of PF-04447943
Measured: 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
Measured: 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
Area under the plasma concentration-time from time zero to time of last measurable concentration. Observed using the linear/log trapezoidal method.
Measured: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jun 201620 Oct 2016

First posted30 May 2016 (estimated)
Study start29 Jun 2016
Primary completion20 Oct 2016
Study completion20 Oct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02785770
Sponsor's protocol ID: B0401018
Status last verified: Jun 2018
First submitted: 25 May 2016
Last updated: 28 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02785770
Acronym / sponsor ID: B0401018
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 29 Jun 2016 (actual)
Primary completion: 20 Oct 2016 (actual)
Study completion: 20 Oct 2016 (actual)
First posted: 30 May 2016 (estimated)
Results: Posted 28 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
PF-04447943 low dose	Experimental	Drug: PF-0444794325 mg of PF-04447943
PF-04447943 high dose	Experimental	Drug: PF-04447943100 mg of PF-04447943
Placebo	Placebo comparator	Drug: PlaceboMatching placebo for PF-04447943
Moxifloxacin	Active comparator	Drug: Moxifloxacin400 mg of moxifloxacin

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PF-04447943Single oral dose of PF-04447943 administered as an extemporaneously prepared solution	Drug	PF-04447943 high dose, PF-04447943 low dose
PlaceboSingle oral dose of matching placebo for PF-04447943 administered as an extemporaneously prepared solution	Drug	Placebo
MoxifloxacinSingle oral dose of moxifloxacin administered as tablet	Drug	Moxifloxacin

Primary outcome

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
Time frame: 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.
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 1 Hour Post-Dose
Time frame: 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.
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 2 Hours Post-Dose
Time frame: 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.
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 3 Hours Post-Dose
Time frame: 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.
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 4 Hours Post-Dose
Time frame: 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.
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 8 Hours Post-Dose
Time frame: 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.
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 12 Hours Post-Dose
Time frame: 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.
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 24 Hours Post-Dose
Time frame: 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.

12 secondary outcomes

Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for Moxifloxacin and Placebo
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days)
Number of Participants With Physical Examination Abnormalities
Time frame: Baseline (Pre-dose)
Number of Participants With Electrocardiogram (ECG) Abnormalities
Time frame: Baseline up to 24 hours post-dose
Number of Participants With Vital Sign Abnormalities
Time frame: Baseline (Pre-dose) up to 24 hours post-dose
Number of Participants With Laboratory Test Abnormalities
Time frame: Baseline (Pre-dose) up to 24 hours post-dose
Maximum Plasma Concentration (Cmax) of PF-04447943
Time frame: 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
Time frame: 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
Time frame: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose

Results and safety

Results posted to the registry on 28 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Moxifloxacin, Placebo, PF-04447943 100 mg, PF-04447943 25 mg	11	11
PF-04447943 25 mg, Moxifloxacin, Placebo, PF-04447943 100 mg	11	11
Placebo, PF-04447943 100 mg, PF-04447943 25 mg, Moxifloxacin	11	11
PF-04447943 100 mg, PF-04447943 25 mg, Moxifloxacin, Placebo	11	11

Primary outcome: 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

Time frame: 0.5 hour post-dose. Least squares mean (Standard Error). Unit: Millisecond (Msec)

Measure	PF-04447943 25 mg n = 43	PF-04447943 100 mg n = 42	Placebo n = 42
Value	404.09 (0.9544)	408.92 (0.9659)	404.38 (0.9653)

PF-04447943 25 mg vs Placebo: Least Square (LS) Mean Difference: -0.29 (90% CI -2.38 to 1.80), p = 0.8195, Repeated Measures Model
PF-04447943 100 mg vs Placebo: LS Mean Difference: 4.54 (90% CI 2.44 to 6.64), p = 0.0004, Repeated Measures Model

Population analysed: Electrocardiogram (ECG) analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.

Primary outcome: Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 1 Hour Post-Dose

Time frame: 1 hour post-dose. Least squares mean (Standard Error). Unit: Msec

Measure	PF-04447943 25 mg n = 43	PF-04447943 100 mg n = 42	Placebo n = 42
Value	404.23 (0.9544)	409.14 (0.965)	404.09 (0.9653)

PF-04447943 25 mg vs Placebo: LS mean difference: 0.14 (90% CI -1.95 to 2.22), p = 0.9146, Repeated Measures Model
PF-04447943 100 mg vs Placebo: LS mean difference: 5.04 (90% CI 2.95 to 7.14), p <0.0001, Repeated Measures Model

Population analysed: ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.

Primary outcome: Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 2 Hours Post-Dose

Time frame: 2 hours post-dose. Least squares mean (Standard Error). Unit: Msec

Measure	PF-04447943 25 mg n = 43	PF-04447943 100 mg n = 42	Placebo n = 42
Value	403.76 (0.9544)	406.78 (0.9659)	402.52 (0.9653)

PF-04447943 25 mg vs Placebo: LS mean difference: 1.24 (90% CI -0.84 to 3.33), p = 0.3272, Repeated Measures Model
PF-04447943 100 mg vs Placebo: LS mean difference: 4.26 (90% CI 2.16 to 6.36), p = 0.0009, Repeated Measures Model

Population analysed: ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.

Primary outcome: Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 3 Hours Post-Dose

Time frame: 3 hours post-dose. Least squares mean (Standard Error). Unit: Msec

Measure	PF-04447943 25 mg n = 43	PF-04447943 100 mg n = 42	Placebo n = 42
Value	403.95 (0.9544)	406.69 (0.9659)	404.43 (0.9653)

PF-04447943 25 mg vs Placebo: LS mean difference: -0.48 (90% CI -2.57 to 1.60), p = 0.7024, Repeated Measures Model
PF-04447943 100 mg vs Placebo: LS mean difference: 2.26 (90% CI 0.16 to 4.36), p = 0.0768, Repeated Measures Model

Population analysed: ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PF-04447943 25 mg	0 of 43 (0%)	7 of 43 (16.3%)	0 of 43
PF-04447943 100 mg	0 of 42 (0%)	3 of 42 (7.1%)	0 of 42
Moxifloxacin 400 mg	0 of 41 (0%)	3 of 41 (7.3%)	0 of 41
Placebo	0 of 42 (0%)	2 of 42 (4.8%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Healthy Volunteer, Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-04447943 and Moxifloxacin in people with Healthy, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 0.5 hour post-dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02785770.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2018.