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PF-06678552

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Jul 31, 2014

PF-06678552 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Mar 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment62

FDA Designations

No designations recorded

PF-06678552 clinical trials

PF-06678552 · 2 trials · 1 indication

Phase 1 2
NCT02079922A Multiple Dose Study Of PF-06678552 In Healthy SubjectsHealthy
COMPLETED38 Analytics
NCT01992614A Single Dose Study Of PF-06678552 In Healthy SubjectsHealthy
COMPLETED24 Analytics
PHASE1COMPLETED
A Multiple Dose Study Of PF-06678552 In Healthy Subjects
HealthyUnlock trial analytics
PHASE1COMPLETED
A Single Dose Study Of PF-06678552 In Healthy Subjects
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate), and cardiac conduction intervals as assessed by 12 lead ECG.
0 to 24 days post dose
Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate) and cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG).
0 to 72 hours post dose

Secondary Endpoints

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 1
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 7
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 14
0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALSingle dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Cohort 2EXPERIMENTALSingle dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Cohort 3EXPERIMENTALSingle dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Cohort 4EXPERIMENTALSingle dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Cohort 5EXPERIMENTALSingle dose level of PF-06678552 or placebo will be provided either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Cohort 6EXPERIMENTALSingle dose level of PF-06678552 or placebo will be provided either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Interventions

NameTypeDescription
PF-06678552DRUGPF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PlaceboDRUGPF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or PlaceboDRUGPF-06678552 or placebo will be administered as an extemporaneously prepared solution once in each period.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/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 * Low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL Exclusion Criteria: * Evidence or history of clinically signi...

Countries:Belgium
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Frequently asked questions about PF-06678552

What is PF-06678552?

PF-06678552 is an investigational small molecule developed by Pfizer, Inc. It has been studied in Phase 1 clinical trials in healthy adult volunteers rather than in patients with a specific disease. No therapeutic indication for PF-06678552 has been disclosed.

Who makes PF-06678552?

PF-06678552 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored both of the Phase 1 studies conducted with this compound.

What phase is PF-06678552 in?

PF-06678552 is in Phase 1 clinical development. Both of its trials were Phase 1 studies, and both are now completed. There are no active trials of PF-06678552 listed, and the compound is investigational rather than approved.

What clinical trials is PF-06678552 in?

PF-06678552 has been evaluated in two completed Phase 1 trials: NCT02079922, a multiple dose study in healthy subjects with 38 participants, and NCT01992614, a single dose study in healthy subjects with 24 participants. Both were conducted in Belgium and together enrolled 62 healthy volunteers.

How were the PF-06678552 trials designed?

Both PF-06678552 Phase 1 trials were randomized, double blind, and controlled studies in healthy adult volunteers aged 18 years and older. NCT02079922 tested multiple doses in 38 subjects, while NCT01992614 tested a single dose in 24 subjects. Both studies were run in Belgium and are completed.