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Completed

NCT Number: NCT02391623

A Multiple Oral Doses Study Of PF-06427878 In Healthy Adult Subjects

PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple oral doses of PF-06427878 in healthy adult subjects.

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Key information

Conditions

Healthy Subjects Dyslipidemias 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 Clinical Research Unit

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 17.5 to 35.4 kg/m2; and a total body weight >50 kg
  • Subjects with fasting TG level of >=90 mg/dL and <=500 mg/dL following an overnight fast
  • Subjects with low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL following an overnight fast

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-06427878

Drug

PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).

Placebo

Drug

Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).

Primary outcomes

  1. Assessment of adverse events (AEs).

    Time frame: 0-25 days

  2. Assessment of clinical laboratory tests.

    Time frame: 0-25 days

  3. Assessment of vital signs (including blood pressure and pulse rate).

    Time frame: 0-25 days

  4. Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG).

    Time frame: 0-25 days

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1

    Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

  2. Maximum Observed Plasma Concentration (Cmax) for PF-06427878during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12

    Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

  3. Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 14

    Time frame: 0, 1, 2, 3, 4, 6, 8, 12 hours post dose

  4. Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1

    Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

  5. Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12

    Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

  6. Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14

    Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

  7. Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1

    Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

  8. Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12

    Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

  9. Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14

    Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

  10. Plasma Decay Half-Life (t1/2) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14

    Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

  11. Apparent Volume of Distribution (Vz/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14

    Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

  12. Apparent Oral Clearance (CL/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14

    Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

  13. Minimum Observed Plasma Concentration (Cmin) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14

    Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

  14. Peak:Trough ratio of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14

    Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

  15. Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1

    Time frame: 0, 1, 2, 3, 4, 6, 8, 12 hours post dose

  16. Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD

    Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

  17. Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUCtau)) for PF-06427878 on day14 relative to day 1

    Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

  18. Amount of PF-06427878 excreted in urine (Ae) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14

    Time frame: 0- tau hours post dose

  19. Percent of dose excreted in urine as PF-06427878 (Ae%) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14

    Time frame: 0- tau hours post dose

  20. Renal clearance of PF-06427878 (CLr) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14

    Time frame: 0- tau hours post dose

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 Multiple Escalating Oral Doses Of Pf-06427878 Co Administered With And Without Food In Healthy Adult Subjects

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 18, 2015
Registry last updated
Mar 2, 2016

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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