NCT02208284

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 4, 2015

Status Verified

March 1, 2015

Enrollment Period

4 months

First QC Date

July 30, 2014

Last Update Submit

March 3, 2015

Conditions

Healthy

Keywords

Single Ascending Dosehealthy subjectsHyperlipidemiaLipid Metabolism DisordersMetabolic Diseases

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (7)

  • 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 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

  • 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

    0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose

  • +2 more secondary outcomes

Study Arms (3)

Cohort 1-PF-06427878 or placebo

EXPERIMENTAL

Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.

Drug: PF-06427878Drug: Placebo

Cohort 2-PF-06427878 or placebo

EXPERIMENTAL

Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.

Drug: PF-06427878Drug: Placebo

Cohort 3-PF-06427878 or placebo

EXPERIMENTAL

Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.

Drug: PF-06427878Drug: Placebo

Interventions

PF-06427878DRUG

PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.

Cohort 1-PF-06427878 or placebo
PlaceboDRUG

PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.

Cohort 1-PF-06427878 or placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Links

MeSH Terms

Conditions

HyperlipidemiasLipid Metabolism DisordersMetabolic Diseases

Condition Hierarchy (Ancestors)

DyslipidemiasNutritional and Metabolic Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2014

First Posted

August 5, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 4, 2015

Record last verified: 2015-03

Locations

US(1)