First In Human Study Of Increasing Oral Doses Of PF-04634817

October 12, 2010 updated by: Pfizer

A Double Blind, Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Pharmacokinetics (In The Fed And Fasted State), Safety And Toleration Of Single Oral Doses Of PF-04634817 In Healthy Volunteers

The study will evaluate the hypothesis that at doses and plasma concentrations which affect pharmacodynamic markers of activity at the chemokine receptors, CCR2 and CCR5, the compound is safe and well tolerated. It will also evaluate the hypothesis that the pharmacokinetic profile is robust and consistent with a once or twice a day therapeutic administration.

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

United States
- Connecticut
  - New Haven, Connecticut, United States, 06511
    - 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 or female (of non-child bearing potential) subjects between 18 and 55 years of age.
Body mass index of 17.5 to 30.5 kg/m2 and total body weight > 50kg.

Exclusion Criteria:

Evidence or history of any clinically significant disease.
Treatment with an investigational drug within 30 days of study start
Use of prescription and non-prescription medicines within 7 days of study start

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: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: PF-04634817 Placebo Oral solution, placebo, single dose Drug: PF-04634817 Placebo Oral solution, placebo, single dose after food
Experimental: Cohort 1, 1mg	Drug: PF-04634817 Oral solution, 1mg, single dose Drug: PF-04634817 Oral solution, 3mg, single dose Drug: PF-04634817 Oral solution, 10mg, single dose Drug: PF-04634817 Oral solution, 30mg, single dose Drug: PF-04634817 Oral solution, 100mg, single dose Drug: PF-04634817 Oral solution, 300mg, single dose Drug: PF-04634817 Oral solution, 600mg, single dose Drug: PF-04634817 Oral solution, 900mg, single dose Drug: PF-04634817 Oral solution, up to 900mg, single dose after food
Experimental: Cohort 1, 3mg	Drug: PF-04634817 Oral solution, 1mg, single dose Drug: PF-04634817 Oral solution, 3mg, single dose Drug: PF-04634817 Oral solution, 10mg, single dose Drug: PF-04634817 Oral solution, 30mg, single dose Drug: PF-04634817 Oral solution, 100mg, single dose Drug: PF-04634817 Oral solution, 300mg, single dose Drug: PF-04634817 Oral solution, 600mg, single dose Drug: PF-04634817 Oral solution, 900mg, single dose Drug: PF-04634817 Oral solution, up to 900mg, single dose after food
Experimental: Cohort 1, 10mg	Drug: PF-04634817 Oral solution, 1mg, single dose Drug: PF-04634817 Oral solution, 3mg, single dose Drug: PF-04634817 Oral solution, 10mg, single dose Drug: PF-04634817 Oral solution, 30mg, single dose Drug: PF-04634817 Oral solution, 100mg, single dose Drug: PF-04634817 Oral solution, 300mg, single dose Drug: PF-04634817 Oral solution, 600mg, single dose Drug: PF-04634817 Oral solution, 900mg, single dose Drug: PF-04634817 Oral solution, up to 900mg, single dose after food
Experimental: Cohort 2, 30mg	Drug: PF-04634817 Oral solution, 1mg, single dose Drug: PF-04634817 Oral solution, 3mg, single dose Drug: PF-04634817 Oral solution, 10mg, single dose Drug: PF-04634817 Oral solution, 30mg, single dose Drug: PF-04634817 Oral solution, 100mg, single dose Drug: PF-04634817 Oral solution, 300mg, single dose Drug: PF-04634817 Oral solution, 600mg, single dose Drug: PF-04634817 Oral solution, 900mg, single dose Drug: PF-04634817 Oral solution, up to 900mg, single dose after food
Experimental: Cohort 2, 100mg	Drug: PF-04634817 Oral solution, 1mg, single dose Drug: PF-04634817 Oral solution, 3mg, single dose Drug: PF-04634817 Oral solution, 10mg, single dose Drug: PF-04634817 Oral solution, 30mg, single dose Drug: PF-04634817 Oral solution, 100mg, single dose Drug: PF-04634817 Oral solution, 300mg, single dose Drug: PF-04634817 Oral solution, 600mg, single dose Drug: PF-04634817 Oral solution, 900mg, single dose Drug: PF-04634817 Oral solution, up to 900mg, single dose after food
Experimental: Cohort 2, 300mg	Drug: PF-04634817 Oral solution, 1mg, single dose Drug: PF-04634817 Oral solution, 3mg, single dose Drug: PF-04634817 Oral solution, 10mg, single dose Drug: PF-04634817 Oral solution, 30mg, single dose Drug: PF-04634817 Oral solution, 100mg, single dose Drug: PF-04634817 Oral solution, 300mg, single dose Drug: PF-04634817 Oral solution, 600mg, single dose Drug: PF-04634817 Oral solution, 900mg, single dose Drug: PF-04634817 Oral solution, up to 900mg, single dose after food
Experimental: Cohort 3, 600mg	Drug: PF-04634817 Oral solution, 1mg, single dose Drug: PF-04634817 Oral solution, 3mg, single dose Drug: PF-04634817 Oral solution, 10mg, single dose Drug: PF-04634817 Oral solution, 30mg, single dose Drug: PF-04634817 Oral solution, 100mg, single dose Drug: PF-04634817 Oral solution, 300mg, single dose Drug: PF-04634817 Oral solution, 600mg, single dose Drug: PF-04634817 Oral solution, 900mg, single dose Drug: PF-04634817 Oral solution, up to 900mg, single dose after food
Experimental: Cohort 3, 900mg	Drug: PF-04634817 Oral solution, 1mg, single dose Drug: PF-04634817 Oral solution, 3mg, single dose Drug: PF-04634817 Oral solution, 10mg, single dose Drug: PF-04634817 Oral solution, 30mg, single dose Drug: PF-04634817 Oral solution, 100mg, single dose Drug: PF-04634817 Oral solution, 300mg, single dose Drug: PF-04634817 Oral solution, 600mg, single dose Drug: PF-04634817 Oral solution, 900mg, single dose Drug: PF-04634817 Oral solution, up to 900mg, single dose after food
Experimental: Cohort 3, up to 900mg (fed)	Drug: PF-04634817 Oral solution, 1mg, single dose Drug: PF-04634817 Oral solution, 3mg, single dose Drug: PF-04634817 Oral solution, 10mg, single dose Drug: PF-04634817 Oral solution, 30mg, single dose Drug: PF-04634817 Oral solution, 100mg, single dose Drug: PF-04634817 Oral solution, 300mg, single dose Drug: PF-04634817 Oral solution, 600mg, single dose Drug: PF-04634817 Oral solution, 900mg, single dose Drug: PF-04634817 Oral solution, up to 900mg, single dose after food
Placebo Comparator: Cohort 3, placebo (fed)	Drug: PF-04634817 Placebo Oral solution, placebo, single dose Drug: PF-04634817 Placebo Oral solution, placebo, single dose after food

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and toleration: adverse events, supine and standing vital sign measurements, telemetry, 12-lead ECGs, blood and urine tests Time Frame: 0-3 days	0-3 days
Plasma pharmacokinetics: Cmax, Tmax, AUClast, AUCinf, AUC0-24, CL/F, Vz/F and T1/2 Time Frame: 0-4 days	0-4 days
Urinary pharmacokinetics: Aet (mount excreted in urine), Aet% and CLr Time Frame: 0-2 days	0-2 days
p-ERK inhibition in human monocytes Time Frame: 0-3 days	0-3 days
Change in circulating monocytes Time Frame: 0-3 days	0-3 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in plasma MCP-1 Time Frame: 0-3 days	0-3 days
MIP 1B stimulated CCR5 receptor internalization Time Frame: 0-3 days	0-3 days
MCP-1 stimulated CCR5 receptor internalization Time Frame: 0-3 days	0-3 days

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

April 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

March 26, 2010

First Submitted That Met QC Criteria

April 1, 2010

First Posted (Estimate)

April 5, 2010

Study Record Updates

Last Update Posted (Estimate)

October 13, 2010

Last Update Submitted That Met QC Criteria

October 12, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

B1261002

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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First In Human Study Of Increasing Oral Doses Of PF-04634817

A Double Blind, Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Pharmacokinetics (In The Fed And Fasted State), Safety And Toleration Of Single Oral Doses Of PF-04634817 In Healthy Volunteers

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

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-04634817 Placebo

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