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Study to Investigate the Safety, Tolerability, Pharmacokinetics of PF-06305591 in Healthy Male and Female Subjects

NCT ID: NCT01747941

Last Updated: 2013-05-23

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-05-31

Brief Summary

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The study is designed to test safety tolerability and PK of single oral ascending doses of PF-06305591,

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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

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

Single ascending oral doses in fasted conditions

Group Type EXPERIMENTAL

PF-06305591

Intervention Type DRUG

single dose, solution

Placebo

Intervention Type DRUG

matching placebo

Cohort 2

Single ascending oral doses in fasted conditions

Group Type EXPERIMENTAL

PF-06305591

Intervention Type DRUG

single dose, solution

Placebo

Intervention Type DRUG

matching placebo

Cohort 3

Single ascending oral doses in fed conditions

Group Type EXPERIMENTAL

PF-06305591

Intervention Type DRUG

single dose, solution

Placebo

Intervention Type DRUG

matching placebo

Interventions

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PF-06305591

single dose, solution

Intervention Type DRUG

Placebo

matching placebo

Intervention Type DRUG

PF-06305591

single dose, solution

Intervention Type DRUG

Placebo

matching placebo

Intervention Type DRUG

PF-06305591

single dose, solution

Intervention Type DRUG

Placebo

matching placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy young subjects
* aged 18-55

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 the time of dosing).
* Pregnant or 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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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=B5281001&StudyName=Study%20to%20Investigate%20the%20Safety%2C%20Tolerability%2C%20Pharmacokinetics%20of%20PF-06305591%20in%20Healthy%20Male%20and%20Female%20Subjects%20

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

Other Identifiers

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B5281001

Identifier Type: -

Identifier Source: org_study_id

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