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Clinical Trials/NCT02855177
NCT02855177CompletedPhase 1

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

Pfizer2 sites in 1 country24 target enrollmentStarted: August 24, 2016Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Pfizer
Enrollment
24
Locations
2
Primary Endpoint
Change from baseline in clinical laboratory tests
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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).

Arms & Interventions

Placebo

Placebo Comparator

Placebo will be administered as an extemporaneously prepared suspension every 8 hours for 14 days

Intervention: Placebo (Drug)

PF-06427878

Experimental

PF-06427878 will be administered as an extemporaneously prepared suspension every 8 hours for 14 days

Intervention: PF-06427878 (Drug)

Outcomes

Primary Outcomes

Change from baseline in clinical laboratory tests

Time Frame: Day 1 to Day 22

Change from baseline in vital signs

Time Frame: Day 0 to Day 22

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

Time Frame: Day 0 to Day 22

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

Time Frame: Day -2 to Day 44

Secondary Outcomes

  • Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 1(0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose)
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 on day 1(0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose)
  • Area Under the Curve for PF-06427878 during the dosing interval (AUCtau) on day 1(0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose)
  • Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 14(0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose)
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 on day 14(0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose)
  • Area Under the Curve for PF-06427878 during the dosing interval (AUCtau) on day 14(0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose)
  • Plasma Decay Half-Life (t1/2) for PF-06427878 on day 14(0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose)
  • Apparent Oral Clearance (CL/F) of PF-06427878 on day 14(0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose)
  • Apparent Volume of Distribution (Vz/F) of PF-06427878 on day 14(0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose)
  • Minimum Observed Plasma Concentration (Cmin) for PF-06427878 on day 14(0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose)
  • Peak:Trough ratio of PF-06427878 on day 14(0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose)
  • Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUCtau)) for PF-06427878 on day 14 relative to day 1(0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose)
  • Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day 14 relative to day 1(0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose)
  • Amount of PF-06427878 excreted in urine (Ae) on day 14(0-8 hours post dose)
  • Percent of dose excreted in urine as PF-06427878 (Ae%) on day 14(0-8 hours post dose)
  • Renal clearance of PF-06427878 (CLr) on day 14(0-8 hours post dose)

Investigators

Sponsor
Pfizer
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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