NCT02079922

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 multiple oral doses of PF-06678552 in healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Mar 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

Study Start

First participant enrolled

March 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 31, 2014

Status Verified

July 1, 2014

Enrollment Period

4 months

First QC Date

March 4, 2014

Last Update Submit

July 29, 2014

Conditions

Healthy

Keywords

Multiple Ascending Dosehealthy subjectsHypercholesterolemiaHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic Diseases

Outcome Measures

Primary Outcomes (1)

  • Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate), and cardiac conduction intervals as assessed by 12 lead ECG.

    0 to 24 days post dose

Secondary Outcomes (40)

  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 1

    0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 7

    0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 14

    0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  • Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 1

    0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  • Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 7

    0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

  • +35 more secondary outcomes

Study Arms (6)

Cohort 1

EXPERIMENTAL

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

Drug: PF-06678552Drug: Placebo

Cohort 2

EXPERIMENTAL

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

Drug: PF-06678552Drug: Placebo

Cohort 3

EXPERIMENTAL

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

Drug: PF-06678552Drug: Placebo

Cohort 4

EXPERIMENTAL

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

Drug: PF-06678552Drug: Placebo

Cohort 5

EXPERIMENTAL

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.

Drug: PF-06678552Drug: Placebo

Cohort 6

EXPERIMENTAL

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.

Drug: PF-06678552Drug: Placebo

Interventions

PF-06678552DRUG

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

Cohort 1
PlaceboDRUG

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

Cohort 1

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 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

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)

Pfizer Investigational Site

Brussels, B-1070, Belgium

Location

Related Links

MeSH Terms

Conditions

HypercholesterolemiaHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional 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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 6, 2014

Study Start

March 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

July 31, 2014

Record last verified: 2014-07

Locations

BE(1)