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Completed

NCT Number: NCT02079922

A Multiple Dose Study Of PF-06678552 In Healthy Subjects

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.

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Key information

Conditions

Healthy Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Brussels, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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)

Treatment and study plan

PF-06678552

Drug

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

Placebo

Drug

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

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PF-06678552 After Administration Of Multiple Escalating Oral Doses In Healthy Adult Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 6, 2014
Registry last updated
Jul 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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