Clinical trial NCT01992614: A Single Dose Study Of PF-06678552 In Healthy Subjects
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PF-06678552 After Fed And Fasted Administration Of Single Escalating Oral Doses In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Single Ascending Dose
healthy subjects
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 24
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-06678552 is a new compound proposed for the treatment of hypercholesteremia. The primary purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-06678552 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects of non childbearing potential.
* Body Mass Index (BMI) of 18 to 30.5 kg/m2; and a total body weight \>50 kg
* Low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL

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), clinical laboratory tests, vital signs (including blood pressure and pulse rate) and cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG).
timeFrame: 0 to 72 hours post dose
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552
timeFrame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] for PF-06678552
timeFrame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
measure: Maximum Observed Plasma Concentration (Cmax) for for PF-06678552
timeFrame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06678552
timeFrame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
measure: Plasma Decay Half-Life (t1/2) for PF-06678552
timeFrame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
measure: Apparent Oral Clearance (CL/F) for PF-06678552
timeFrame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
measure: Apparent Volume of Distribution (Vz/F) for PF-06678552
timeFrame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927
timeFrame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] for PF-06644927
timeFrame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
measure: Maximum Observed Plasma Concentration (Cmax) for PF-06644927
timeFrame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927
timeFrame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
measure: Plasma Decay Half-Life (t1/2) for PF-06644927
timeFrame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
measure: Amount of PF-06644927 excreted in the urine (Ae)
timeFrame: 0-4, 4-12, and 12-24 hours post dose
measure: Percent of PF-06678552 dose excreted in the urine as PF-06644927 (Ae%)
timeFrame: 0-4, 4-12, and 12-24 hours post dose
measure: Renal Clearance (CLr) for PF-06644927
timeFrame: 0-4, 4-12, and 12-24 hours post dose
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: