Clinical trial NCT02208284: A Single Oral Dose Study Of PF-06427878 In Healthy Adult Subjects
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06427878 Co-administered With Meal In Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Single Ascending Dose
healthy subjects
Hyperlipidemia
Lipid Metabolism Disorders
Metabolic Diseases
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-08-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Assessment of adverse events (AEs).
timeFrame: 0-48 h post dose
measure: Assessment of clinical laboratory tests.
timeFrame: 0-48 h post dose
measure: Assessment of vital signs (including blood pressure and pulse rate).
timeFrame: 0-48 h post dose
measure: Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG).
timeFrame: 0-48 h post dose
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06427878
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] for PF-06427878
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
measure: Maximum Observed Plasma Concentration (Cmax) for PF-06427878
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
measure: Apparent Oral Clearance (CL/F) for PF-06427878
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
measure: Apparent Volume of Distribution (Vz/F) for PF-06427878
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
measure: Plasma Decay Half-Life (t1/2) for PF-06427878
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
Other outcomes:
Locations:
city: New Haven
country: United States
facility: New Haven Clinical Research Unit
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: