Healthy Volunteers
Conditions
Keywords
Hyperlipidemia
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.
Interventions
DRUGPlacebo
Placebo as suspension administered every 8 hours, with food
DRUGPF-06427878
500 mg suspension administered every 8 hours, with food
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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).
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 1 | 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 |
| Peak:Trough ratio of 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 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 |
Countries
United States
Outcome results
None listed