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A Study Comparing PF-05089771 TS Capsule To PF-05089771 TS Oral Dispersion In The Fasted State

NCT ID: NCT01690351

Last Updated: 2012-12-12

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-09-30

Brief Summary

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The primary purpose of this study is to estimate the relative bioavailability and food effect of a PF-05089771 capsule.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PF-05089771 Oral Dispersion fasted

Oral dispersion TS formulation- fasted

Group Type EXPERIMENTAL

PF-05089771

Intervention Type DRUG

Oral dispersion TS formulation- fasted

PF-05089771 TS formulation fasted

Capsules TS formulation- fasted

Group Type EXPERIMENTAL

PF-05089771

Intervention Type DRUG

Capsules TS formulation- fasted

Interventions

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PF-05089771

Oral dispersion TS formulation- fasted

Intervention Type DRUG

PF-05089771

Capsules TS formulation- fasted

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and/or non-childbearing potential female subjects between the ages of 18 and 55 years

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).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
* Treatment with an investigational drug within 60 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
* Screening supine blood pressure ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), on a single measurement (confirmed by a single repeat, if necessary) following at least 5 minutes of rest 7. Single 12-lead ECG demonstrating QTc \>450 msec or a QRS interval \>120 mseca at screening. If QTc exceeds 450 msec, or QRS exceeds \>120 mseca the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject's eligibility.
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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Responsibility Role SPONSOR

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=B3291015&StudyName=A%20Study%20Comparing%20PF-05089771%20TS%20Capsule%20To%20PF-05089771%20TS%20Oral%20Dispersion%20In%20The%20Fasted%20State%20

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

Other Identifiers

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B3291015

Identifier Type: -

Identifier Source: org_study_id