Healthy Subjects
Conditions
Keywords
Multiple Ascending Dose, Healthy Subjects, Hyperlipidemia, Lipid Metabolism Disorders, Metabolic Diseases
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 of multiple oral doses of PF-06427878 in healthy adult subjects.
Interventions
DRUGPF-06427878
PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
DRUGPlacebo
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, 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 17.5 to 35.4 kg/m2; and a total body weight \>50 kg * Subjects with fasting TG level of \>=90 mg/dL and \<=500 mg/dL following an overnight fast * Subjects with low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL following an overnight fast
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 |
|---|---|
| Assessment of adverse events (AEs). | 0-25 days |
| Assessment of clinical laboratory tests. | 0-25 days |
| Assessment of vital signs (including blood pressure and pulse rate). | 0-25 days |
| Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG). | 0-25 days |
Secondary
| Measure | Time frame |
|---|---|
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1 | 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12 | 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 | 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose |
| Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1 | 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose |
| Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12 | 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose |
| Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 | 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose |
| Plasma Decay Half-Life (t1/2) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 | 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose |
| Apparent Volume of Distribution (Vz/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 | 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose |
| Amount of PF-06427878 excreted in urine (Ae) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 | 0- tau hours post dose |
| Minimum Observed Plasma Concentration (Cmin) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 | 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose |
| Peak:Trough ratio of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 | 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose |
| Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1 | 0, 1, 2, 3, 4, 6, 8, 12 hours post dose |
| Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD | 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose |
| Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUCtau)) for PF-06427878 on day14 relative to day 1 | 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose |
| Percent of dose excreted in urine as PF-06427878 (Ae%) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 | 0- tau hours post dose |
| Renal clearance of PF-06427878 (CLr) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 | 0- tau hours post dose |
| Apparent Oral Clearance (CL/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 | 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose |
| Maximum Observed Plasma Concentration (Cmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1 | 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose |
| Maximum Observed Plasma Concentration (Cmax) for PF-06427878during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12 | 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose |
| Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 14 | 0, 1, 2, 3, 4, 6, 8, 12 hours post dose |
Countries
Belgium
Outcome results
None listed