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
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 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
Study Sites (2)
Loading locations...
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