A Multiple Dose Safety And Pharmacokinetic (PK) Study Of PF-06427878 In Overweight-Obese, Otherwise Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Placebo
* Drug: PF-06427878


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo will be administered as an extemporaneously prepared suspension every 8 hours for 14 days | Drug: Placebo<br>* Placebo as suspension administered every 8 hours, with food<br>|
| Experimental: PF-06427878<br>PF-06427878 will be administered as an extemporaneously prepared suspension every 8 hours for 14 days | Drug: PF-06427878<br>* 500 mg suspension administered every 8 hours, with food<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Treatment Emergent Treatment-Related Adverse Events (AEs) |  | Day -2 to Day 44 | 
| Change from baseline in clinical laboratory tests |  | Day 1 to Day 22 | 
| Change from baseline in vital signs |  | Day 0 to Day 22 | 
| Change from baseline in cardiac conduction intervals assessed via 12-lead electrocardiogram |  | Day 0 to Day 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Volume of Distribution (Vz/F) of 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperlipidemia