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Completed

NCT Number: NCT02855177

A Multiple Dose Safety And Pharmacokinetic (PK) Study Of PF-06427878 In Overweight-Obese, Otherwise Healthy 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 after 2 weeks of dosing of PF-06427878 in overweight-obese, otherwise healthy adult subjects.

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Key information

Conditions

Healthy Volunteers 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

California Clinical Trials Medical Group, Glendale, California, United States

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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 >=25 kg/m2; and a total body weight >50 kg
  • Subjects with liver fat >=6% and <=20%

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

Placebo

Drug

Placebo as suspension administered every 8 hours, with food

PF-06427878

Drug

500 mg suspension administered every 8 hours, with food

Primary outcomes

  1. Number of Treatment Emergent Treatment-Related Adverse Events (AEs)

    Time frame: Day -2 to Day 44

  2. Change from baseline in clinical laboratory tests

    Time frame: Day 1 to Day 22

  3. Change from baseline in vital signs

    Time frame: Day 0 to Day 22

  4. Change from baseline in cardiac conduction intervals assessed via 12-lead electrocardiogram

    Time frame: Day 0 to Day 22

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 1

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 on day 1

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose

  3. Area Under the Curve for PF-06427878 during the dosing interval (AUCtau) on day 1

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose

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

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose

  5. Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 on day 14

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose

  6. Area Under the Curve for PF-06427878 during the dosing interval (AUCtau) on day 14

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose

  7. Plasma Decay Half-Life (t1/2) for PF-06427878 on day 14

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose

  8. Apparent Volume of Distribution (Vz/F) of PF-06427878 on day 14

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose

  9. Apparent Oral Clearance (CL/F) of PF-06427878 on day 14

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose

  10. Minimum Observed Plasma Concentration (Cmin) for PF-06427878 on day 14

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose

  11. Peak:Trough ratio of PF-06427878 on day 14

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose

  12. Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUCtau)) for PF-06427878 on day 14 relative to day 1

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose

  13. Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day 14 relative to day 1

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose

  14. Amount of PF-06427878 excreted in urine (Ae) on day 14

    Time frame: 0-8 hours post dose

  15. Percent of dose excreted in urine as PF-06427878 (Ae%) on day 14

    Time frame: 0-8 hours post dose

  16. Renal clearance of PF-06427878 (CLr) on day 14

    Time frame: 0-8 hours post dose

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel-group Study To Assess The Safety, Tolerability, And Pharmacokinetics With 2-weeks Of Dosing Of Pf-06427878 In Overweight-obese, Otherwise Healthy Adult Subjects

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 4, 2016
Registry last updated
May 4, 2017

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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