Healthy
Conditions
Keywords
Single 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 single oral doses of PF-06427878 in healthy adult subjects.
Interventions
DRUGPF-06427878
PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
DRUGPlacebo
PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
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
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). | 0-48 h post dose |
| Assessment of clinical laboratory tests. | 0-48 h post dose |
| Assessment of vital signs (including blood pressure and pulse rate). | 0-48 h post dose |
| Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG). | 0-48 h post dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apparent Oral Clearance (CL/F) for PF-06427878 | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06427878 | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) |
| Plasma Decay Half-Life (t1/2) for PF-06427878 | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
| Apparent Volume of Distribution (Vz/F) for PF-06427878 | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] for PF-06427878 | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose | AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf). |
| Maximum Observed Plasma Concentration (Cmax) for PF-06427878 | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose | — |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose | — |
Countries
United States
Outcome results
None listed