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A Multiple Dose Study Of PF-06678552 In Healthy Subjects

NCT ID: NCT02079922

Last Updated: 2014-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-07-31

Brief Summary

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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 multiple oral doses of PF-06678552 in healthy subjects.

Detailed Description

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Conditions

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Healthy

Keywords

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Multiple Ascending Dose healthy subjects Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cohort 1

Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Group Type EXPERIMENTAL

PF-06678552

Intervention Type DRUG

PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.

Placebo

Intervention Type DRUG

PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.

Cohort 2

Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Group Type EXPERIMENTAL

PF-06678552

Intervention Type DRUG

PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.

Placebo

Intervention Type DRUG

PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.

Cohort 3

Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Group Type EXPERIMENTAL

PF-06678552

Intervention Type DRUG

PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.

Placebo

Intervention Type DRUG

PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.

Cohort 4

Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Group Type EXPERIMENTAL

PF-06678552

Intervention Type DRUG

PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.

Placebo

Intervention Type DRUG

PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.

Cohort 5

Single dose level of PF-06678552 or placebo will be provided either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Group Type EXPERIMENTAL

PF-06678552

Intervention Type DRUG

PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.

Placebo

Intervention Type DRUG

PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.

Cohort 6

Single dose level of PF-06678552 or placebo will be provided either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Group Type EXPERIMENTAL

PF-06678552

Intervention Type DRUG

PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.

Placebo

Intervention Type DRUG

PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.

Interventions

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PF-06678552

PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.

Intervention Type DRUG

Placebo

PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.

Intervention Type DRUG

PF-06678552

PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.

Intervention Type DRUG

Placebo

PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.

Intervention Type DRUG

PF-06678552

PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.

Intervention Type DRUG

Placebo

PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.

Intervention Type DRUG

PF-06678552

PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.

Intervention Type DRUG

Placebo

PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.

Intervention Type DRUG

PF-06678552

PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.

Intervention Type DRUG

Placebo

PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.

Intervention Type DRUG

PF-06678552

PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.

Intervention Type DRUG

Placebo

PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Brussels, , Belgium

Site Status

Countries

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Belgium

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7611002&StudyName=A%20Multiple%20Dose%20Study%20Of%20PF-06678552%20In%20Healthy%20Subjects

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

Other Identifiers

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B7611002

Identifier Type: -

Identifier Source: org_study_id