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A Multiple Dose Study To Determine Safety, Tolerability, and Pharmacokinetics Of PF-04634817 In Healthy Adult Subjects

NCT ID: NCT01140672

Last Updated: 2011-06-08

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-10-31

Brief Summary

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The goals of this study are to evaluate the safety and tolerability of multiple ascending doses of PF-04634817 administered orally to healthy adult subjects. In additional, the plasma and urinary pharmacokinetics of multiple ascending doses of PF-04634817 administered orally to healthy adult subjects will be evaluated. Finally, the effect of multiple doses of PF-04634817 on circulating monocytes will be explored.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1 (N=10)

Placebo-controlled, multiple doses of PF-04634817 at 3 mg per day for 14 days. (2 placebo: 8 active)

Group Type EXPERIMENTAL

PF-04634817

Intervention Type DRUG

Oral solution of PF-04634817 at 3 mg will be given once daily for 14 days.

Cohort 2 (N=10)

Placebo-controlled, multiple doses of PF-04634817 at 3 mg per day for 14 days. (2 placebo: 8 active)

Group Type EXPERIMENTAL

PF-04634817

Intervention Type DRUG

Oral solution of PF-04634817 at 3 mg will be given once daily for 14 days.

Cohort 3 (N=10)

Placebo-controlled, multiple doses of PF-04634817 at 30 mg per day for 14 days. (2 placebo: 8 active)

Group Type EXPERIMENTAL

PF-04634817

Intervention Type DRUG

Oral solution of PF-04634817 at 30 mg will be given once daily for 14 days.

Cohort 4 (N=10)

Placebo-controlled, multiple doses of PF-04634817 at 100 mg per day for 14 days. (2 placebo: 8 active)

Group Type EXPERIMENTAL

PF-04634817

Intervention Type DRUG

Oral solution of PF-04634817 at 100 mg will be given once daily for 14 days.

Cohort 5 (N=10)

Placebo-controlled, multiple doses of PF-04634817 at 300 mg per day for 14 days. (2 placebo: 8 active)

Group Type EXPERIMENTAL

PF-04634817

Intervention Type DRUG

Oral solution of PF-04634817 at 300 mg will be given once daily for 14 days.

Cohort 6 (N=10) Optional cohort

Placebo-controlled, multiple doses of PF-04634817 up to 300 mg per day for 14 days. (2 placebo: 8 active)

Group Type EXPERIMENTAL

PF-04634817

Intervention Type DRUG

Cohort will only be dosed if necessary. Dose selected for this cohort may be a repeat of a previous cohort or intermediate dose not to exceed 300 mg.

Interventions

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PF-04634817

Oral solution of PF-04634817 at 3 mg will be given once daily for 14 days.

Intervention Type DRUG

PF-04634817

Oral solution of PF-04634817 at 3 mg will be given once daily for 14 days.

Intervention Type DRUG

PF-04634817

Oral solution of PF-04634817 at 30 mg will be given once daily for 14 days.

Intervention Type DRUG

PF-04634817

Oral solution of PF-04634817 at 100 mg will be given once daily for 14 days.

Intervention Type DRUG

PF-04634817

Oral solution of PF-04634817 at 300 mg will be given once daily for 14 days.

Intervention Type DRUG

PF-04634817

Cohort will only be dosed if necessary. Dose selected for this cohort may be a repeat of a previous cohort or intermediate dose not to exceed 300 mg.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female (of non-childbearing potential) subjects between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
* Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication;
* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day;
* Nursing females;
* Females of childbearing potential.
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=B1261003&StudyName=A%20Multiple%20Dose%20Study%20To%20Determine%20Safety%2C%20Tolerability%2C%20and%20Pharmacokinetics%20Of%20PF-04634817%20In%20Healthy%20Adult%20Subjects

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

Other Identifiers

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B1261003

Identifier Type: -

Identifier Source: org_study_id

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