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CompletedNCT02079922Updated Jul 31, 2014

A Multiple Dose Study Of PF-06678552 In Healthy Subjects

A Phase 1 interventional study of PF-06678552 and Placebo in Healthy, sponsored by Pfizer. Completed at 1 site in Belgium. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-31.

Sponsored by Pfizer · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

PF-06678552 is a new compound proposed for the treatment of hypercholesteremia. The primary purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of PF-06678552 in healthy subjects.

02

Conditions studied

  • Healthy

Keywords

  • Multiple Ascending Dose
  • healthy subjects
  • Hypercholesterolemia
  • Hyperlipidemias
  • Dyslipidemias
  • Lipid Metabolism Disorders
  • Metabolic Diseases
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Cohort 1

    Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

    Drug: PF-06678552 · Drug: Placebo

  • Experimental
    Cohort 2

    Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

    Drug: PF-06678552 · Drug: Placebo

  • Experimental
    Cohort 3

    Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

    Drug: PF-06678552 · Drug: Placebo

  • Experimental
    Cohort 4

    Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

    Drug: PF-06678552 · Drug: Placebo

  • Experimental
    Cohort 5

    Single 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.

    Drug: PF-06678552 · Drug: Placebo

  • Experimental
    Cohort 6

    Single 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.

    Drug: PF-06678552 · Drug: Placebo

Interventions

  • DrugPF-06678552

    PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.

  • DrugPlacebo

    PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.

  • DrugPF-06678552

    PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.

  • DrugPlacebo

    PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.

  • DrugPF-06678552

    PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.

  • DrugPlacebo

    PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.

  • DrugPF-06678552

    PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.

  • DrugPlacebo

    PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.

  • DrugPF-06678552

    PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.

  • DrugPlacebo

    PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.

  • DrugPF-06678552

    PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.

  • DrugPlacebo

    PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 0 to 24 days post dose

Secondary outcomes

  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 1

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  2. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 7

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  3. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 14

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  4. Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 1

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  5. Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 7

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  6. Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 14

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  7. Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 1

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  8. Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 7

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  9. Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 14

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  10. Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 on day 1

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  11. Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 on day 7

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  12. Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 on day 14

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  13. Plasma Decay Half-Life (t1/2) for PF-06644927 on day 14

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose

  14. Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06644927 on day 7 relative to day 1

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  15. Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06644927 on day 14 relative to day 1

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  16. Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06644927 on day 7 relative to day 1

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  17. Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06644927 on day 14 relative to day 1

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  18. Amount of PF-06644927 excreted in urine (Ae) on day 14

    Time frame: 0-12 hours post dose

  19. Percent of dose excreted in urine as PF-06644927 (Ae%) on day 14

    Time frame: 0-12 hours post dose

  20. Renal clearance of PF-06644927 (CLr) on day 14

    Time frame: 0-12 hours post dose

  21. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 on day 1

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  22. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 on day 7

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  23. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 on day 14

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  24. Area Under the Curve during the dosing interval (AUCtau) for PF-06678552 on day 1

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  25. Area Under the Curve during the dosing interval (AUCtau) for PF-06678552 on day 7

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  26. Area Under the Curve during the dosing interval (AUCtau) for PF-06678552 on day 14

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  27. Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 1

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  28. Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 7

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  29. Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 14

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  30. Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06678552 on day 1

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  31. Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06678552 on day 7

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  32. Plasma Decay Half-Life (t1/2) for PF-06678552 on day 14

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose

  33. Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06678552 on day 7 relative to day 1

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  34. Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06678552 on day 14 relative to day 1

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  35. Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06678552 on day 7 relative to day 1

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  36. Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06678552 on day 14 relative to day 1

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  37. Apparent Oral Clearance (CL/F) of PF-06678552 on day 7

    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. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  38. Apparent Oral Clearance (CL/F) of PF-06678552 on day 14

    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. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  39. Apparent Volume of Distribution (Vz/F) of PF-06678552 on day 7

    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.

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  40. Apparent Volume of Distribution (Vz/F) of PF-06678552 on day 14

    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.

    Time frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

07

Study locations

1 site
  • Pfizer Investigational Site
    Brussels, B-1070, Belgium
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02079922
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Mar 6, 2014
Start date
Mar 2014
Primary completion
Jul 2014
Completion
Jul 2014
Last update
Jul 31, 2014

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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