A Single Oral Dose Study Of PF-06427878 In Healthy Adult Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PF-06427878; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • New Haven Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1-PF-06427878 or placebo; Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.	Drug: PF-06427878; PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.; Drug: Placebo; PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
Experimental: Cohort 2-PF-06427878 or placebo; Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.	Drug: PF-06427878; PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.; Drug: Placebo; PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
Experimental: Cohort 3-PF-06427878 or placebo; Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.	Drug: PF-06427878; PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.; Drug: Placebo; PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06427878	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)	0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] for PF-06427878	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).	0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
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
Apparent Oral Clearance (CL/F) for PF-06427878	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.	0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
Apparent Volume of Distribution (Vz/F) for PF-06427878	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.	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	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: July 30, 2014
• First Submitted That Met QC Criteria: August 1, 2014
• First Posted (Estimate): August 5, 2014

Study Record Updates

• Last Update Posted (Estimate): March 4, 2015
• Last Update Submitted That Met QC Criteria: March 3, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: healthy subjects; Hyperlipidemia; Lipid Metabolism Disorders; Metabolic Diseases; Single Ascending Dose
• Other Study ID Numbers: B7871001