A Single Oral Dose Study Of PF-06427878 In Healthy Adult Subjects
- Registration Number
- NCT02208284
- 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 of single oral doses of PF-06427878 in healthy adult subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- 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
- 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
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cohort 1-PF-06427878 or placebo Placebo Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK. Cohort 1-PF-06427878 or placebo PF-06427878 Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK. Cohort 2-PF-06427878 or placebo Placebo Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK. Cohort 3-PF-06427878 or placebo Placebo Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK. Cohort 3-PF-06427878 or placebo PF-06427878 Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK. Cohort 2-PF-06427878 or placebo PF-06427878 Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.
- Primary Outcome Measures
Name Time Method Assessment of clinical laboratory tests. 0-48 h post dose Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG). 0-48 h post dose Assessment of adverse events (AEs). 0-48 h post dose Assessment of vital signs (including blood pressure and pulse rate). 0-48 h post dose
- Secondary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) for PF-06427878 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose 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.
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)
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).
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 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.
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.
Trial Locations
- Locations (1)
New Haven Clinical Research Unit
🇺🇸New Haven, Connecticut, United States