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A Study To Evaluate The Safety, Tolerability And Plasma Drug Levels Following A Single Dose Of PF-04995274 In Healthy Adult Volunteers

NCT ID: NCT01091272

Last Updated: 2010-09-20

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

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-09-30

Brief Summary

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The purpose of the study is to evaluate the safety and tolerability of PF-04995274 after administration of a single dose to healthy volunteers, and to evaluate the plasma drug concentrations after single dose in healthy volunteers.

Detailed Description

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The purpose is to evaluate the safety and pharmacokinetics of a single dose of PF-04995274 in healthy adult volunteers.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

Single dose 3 period interleaved cross-over with placebo substitution

Group Type EXPERIMENTAL

PF-04995274

Intervention Type DRUG

Planned single PO 0.15mg, 1.5mg, 15mg doses of PF-04995274 interleaved with cohort 2 such that doses escalate from 0.15 mg to 50 mg.

Cohort 2

Single dose 4 period interleaved cross-over, placebo substitution, with food effect

Group Type EXPERIMENTAL

PF-04995274

Intervention Type DRUG

Planned single PO 0.5mg, 5mg, 50mg doses of PF-04995274, interleaved with cohort 2 such that doses escalate from 0.15 mg to 50 mg interleaved with cohort 2 such that doses escalate from 0.15 mg to 50 mg.

Cohort 3

Single dose 4 period cross-over, placebo insertion, with food effect

Group Type EXPERIMENTAL

PF-04995274

Intervention Type DRUG

Planned single PO 120mg and 210mg doses of PF-04995274

Optional Cohort 4

Single dose 3 period cross-over with placebo substitution

Group Type EXPERIMENTAL

PF-04995274

Intervention Type DRUG

single PO dose of PF-04995274; dosage to be determined by safety and pharmacokinetic data

Interventions

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PF-04995274

Planned single PO 0.15mg, 1.5mg, 15mg doses of PF-04995274 interleaved with cohort 2 such that doses escalate from 0.15 mg to 50 mg.

Intervention Type DRUG

PF-04995274

Planned single PO 0.5mg, 5mg, 50mg doses of PF-04995274, interleaved with cohort 2 such that doses escalate from 0.15 mg to 50 mg interleaved with cohort 2 such that doses escalate from 0.15 mg to 50 mg.

Intervention Type DRUG

PF-04995274

Planned single PO 120mg and 210mg doses of PF-04995274

Intervention Type DRUG

PF-04995274

single PO dose of PF-04995274; dosage to be determined by safety and pharmacokinetic data

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* For all cohorts, healthy male and/or female subjects of nonchildbearing potential between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests).

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).
* Pregnant or nursing women; women of childbearing potential. Female subjects must be of non childbearing potential defined by a history of surgical sterilization (eg, hysterectomy or bilateral oophorectomy) or post menopausal status (complete absence of menses for at least two consecutive years) and elevated FSH concentration in women between 45 and 55.
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

Brussels, , Belgium

Site Status

Countries

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Belgium

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1661001&StudyName=A%20Study%20To%20Evaluate%20The%20Safety%2C%20Tolerability%20And%20Plasma%20Drug%20Levels%20Following%20A%20Single%20Dose%20Of%20PF-04995274%20In%20Healthy%20Adult%20Voluntee

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Other Identifiers

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B1661001

Identifier Type: -

Identifier Source: org_study_id