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

NCT ID: NCT01098877

Last Updated: 2010-10-13

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

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

PF-04634817 Placebo

Intervention Type DRUG

Oral solution, placebo, single dose

Cohort 1, 1mg

Group Type EXPERIMENTAL

PF-04634817

Intervention Type DRUG

Oral solution, 1mg, single dose

Cohort 1, 3mg

Group Type EXPERIMENTAL

PF-04634817

Intervention Type DRUG

Oral solution, 3mg, single dose

Cohort 1, 10mg

Group Type EXPERIMENTAL

PF-04634817

Intervention Type DRUG

Oral solution, 10mg, single dose

Cohort 2, 30mg

Group Type EXPERIMENTAL

PF-04634817

Intervention Type DRUG

Oral solution, 30mg, single dose

Cohort 2, 100mg

Group Type EXPERIMENTAL

PF-04634817

Intervention Type DRUG

Oral solution, 100mg, single dose

Cohort 2, 300mg

Group Type EXPERIMENTAL

PF-04634817

Intervention Type DRUG

Oral solution, 300mg, single dose

Cohort 3, 600mg

Group Type EXPERIMENTAL

PF-04634817

Intervention Type DRUG

Oral solution, 600mg, single dose

Cohort 3, 900mg

Group Type EXPERIMENTAL

PF-04634817

Intervention Type DRUG

Oral solution, 900mg, single dose

Cohort 3, up to 900mg (fed)

Group Type EXPERIMENTAL

PF-04634817

Intervention Type DRUG

Oral solution, up to 900mg, single dose after food

Cohort 3, placebo (fed)

Group Type PLACEBO_COMPARATOR

PF-04634817 Placebo

Intervention Type DRUG

Oral solution, placebo, single dose after food

Interventions

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PF-04634817 Placebo

Oral solution, placebo, single dose

Intervention Type DRUG

PF-04634817

Oral solution, 1mg, single dose

Intervention Type DRUG

PF-04634817

Oral solution, 3mg, single dose

Intervention Type DRUG

PF-04634817

Oral solution, 10mg, single dose

Intervention Type DRUG

PF-04634817

Oral solution, 30mg, single dose

Intervention Type DRUG

PF-04634817

Oral solution, 100mg, single dose

Intervention Type DRUG

PF-04634817

Oral solution, 300mg, single dose

Intervention Type DRUG

PF-04634817

Oral solution, 600mg, single dose

Intervention Type DRUG

PF-04634817

Oral solution, 900mg, single dose

Intervention Type DRUG

PF-04634817

Oral solution, up to 900mg, single dose after food

Intervention Type DRUG

PF-04634817 Placebo

Oral solution, placebo, single dose after food

Intervention Type DRUG

Eligibility Criteria

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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
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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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

New Haven, Connecticut, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1261002&StudyName=First%20In%20Human%20Study%20Of%20Increasing%20Oral%20Doses%20Of%20PF-04634817

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

Other Identifiers

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B1261002

Identifier Type: -

Identifier Source: org_study_id