A Multiple Dose Safety And Pharmacokinetic (PK) Study Of PF-06427878 In Overweight-Obese, Otherwise Healthy Subjects
- Registration Number
- NCT02855177
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo will be administered as an extemporaneously prepared suspension every 8 hours for 14 days PF-06427878 PF-06427878 PF-06427878 will be administered as an extemporaneously prepared suspension every 8 hours for 14 days
- Primary Outcome Measures
Name Time Method 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
Name Time Method Amount of PF-06427878 excreted in urine (Ae) on day 14 0-8 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 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 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
Trial Locations
- Locations (2)
California Clinical Trials Medical Group
🇺🇸Glendale, California, United States
Qps-Mra, Llc
🇺🇸South Miami, Florida, United States