A Multiple Dose Study Of PF-06678552 In Healthy Subjects

July 29, 2014 updated by: Pfizer

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PF-06678552 After Administration Of Multiple Escalating Oral Doses In Healthy Adult Subjects

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.

Study Overview

Status

Completed

Conditions

Healthy

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Belgium
- - Brussels, Belgium, B-1070
    - Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.	Drug: PF-06678552 PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days. Drug: Placebo PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days. 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. 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.
Experimental: Cohort 2 Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.	Drug: PF-06678552 PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days. Drug: Placebo PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days. 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. 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.
Experimental: Cohort 3 Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.	Drug: PF-06678552 PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days. Drug: Placebo PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days. 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. 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.
Experimental: Cohort 4 Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.	Drug: PF-06678552 PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days. Drug: Placebo PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days. 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. 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.
Experimental: 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.	Drug: PF-06678552 PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days. Drug: Placebo PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days. 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. 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.
Experimental: 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.	Drug: PF-06678552 PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days. Drug: Placebo PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days. 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. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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. Time Frame: 0 to 24 days post dose	0 to 24 days post dose

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

March 4, 2014

First Submitted That Met QC Criteria

March 4, 2014

First Posted (Estimate)

March 6, 2014

Study Record Updates

Last Update Posted (Estimate)

July 31, 2014

Last Update Submitted That Met QC Criteria

July 29, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

B7611002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Outcome Measure	Measure Description	Time Frame
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 1 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		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 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		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 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		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 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		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 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		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 14 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 1 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 7 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 14 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 on day 1 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 on day 7 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 on day 14 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Plasma Decay Half-Life (t1/2) for PF-06644927 on day 14 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose		0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose
Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06644927 on day 7 relative to day 1 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06644927 on day 14 relative to day 1 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06644927 on day 7 relative to day 1 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06644927 on day 14 relative to day 1 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Amount of PF-06644927 excreted in urine (Ae) on day 14 Time Frame: 0-12 hours post dose		0-12 hours post dose
Percent of dose excreted in urine as PF-06644927 (Ae%) on day 14 Time Frame: 0-12 hours post dose		0-12 hours post dose
Renal clearance of PF-06644927 (CLr) on day 14 Time Frame: 0-12 hours post dose		0-12 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 on day 1 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		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-06678552 on day 7 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		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-06678552 on day 14 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		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-06678552 on day 1 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		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-06678552 on day 7 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		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-06678552 on day 14 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 1 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 7 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 14 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06678552 on day 1 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06678552 on day 7 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Plasma Decay Half-Life (t1/2) for PF-06678552 on day 14 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose		0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose
Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06678552 on day 7 relative to day 1 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06678552 on day 14 relative to day 1 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06678552 on day 7 relative to day 1 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06678552 on day 14 relative to day 1 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose		0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Apparent Oral Clearance (CL/F) of PF-06678552 on day 7 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose	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, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Apparent Oral Clearance (CL/F) of PF-06678552 on day 14 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose	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, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Apparent Volume of Distribution (Vz/F) of PF-06678552 on day 7 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose	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, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
Apparent Volume of Distribution (Vz/F) of PF-06678552 on day 14 Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose	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, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose

A Multiple Dose Study Of PF-06678552 In Healthy Subjects

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PF-06678552 After Administration Of Multiple Escalating Oral Doses In Healthy Adult Subjects

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Clinical Trials on Healthy

Clinical Trials on PF-06678552

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