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Safety and Tolerability Study of Multiple Doses of PF-06305591

NCT ID: NCT01776619

Last Updated: 2013-12-03

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

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-11-30

Brief Summary

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Safety, tolerability and PK of repeated doses of PF-06305591 will be evaluated in young healthy volunteers toghether with food effect on relative bioavailability of solid formulation after single dose.

Detailed Description

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Conditions

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Healthy

Keywords

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Safety tolerability PK

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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Multiple Dose: Cohort 1

Group Type EXPERIMENTAL

PF-06305591

Intervention Type DRUG

14 day repeated 20mg BID doses

Placebo

Intervention Type DRUG

14 day repeated BID doses

Multiple Dose: Cohort 2

Group Type EXPERIMENTAL

PF-06305591

Intervention Type DRUG

14 day repeated 80mg BID doses

Placebo

Intervention Type DRUG

14 day repeated BID doses

Multiple Dose: Cohort 3

Group Type EXPERIMENTAL

PF-06305591

Intervention Type DRUG

14 day repeated 40mg BID doses

Placebo

Intervention Type DRUG

14 day repeated BID doses

Multiple Dose: Cohort 4

Group Type EXPERIMENTAL

PF-06305591

Intervention Type DRUG

14 day repeated BID doses

Relative Bioavilability: Cohort 1

Group Type EXPERIMENTAL

PF-06305591

Intervention Type DRUG

relative bioavailability tablet vs. solution and food effect at 50mg dose

Interventions

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PF-06305591

14 day repeated 20mg BID doses

Intervention Type DRUG

Placebo

14 day repeated BID doses

Intervention Type DRUG

PF-06305591

14 day repeated 80mg BID doses

Intervention Type DRUG

Placebo

14 day repeated BID doses

Intervention Type DRUG

PF-06305591

14 day repeated 40mg BID doses

Intervention Type DRUG

Placebo

14 day repeated BID doses

Intervention Type DRUG

PF-06305591

14 day repeated BID doses

Intervention Type DRUG

PF-06305591

relative bioavailability tablet vs. solution and food effect at 50mg dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male or female subjects of non childbearing potential, between the ages of 21 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 pulse 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 the time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
Minimum Eligible Age

21 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=B5281002&StudyName=Safety%20and%20Tolerability%20Study%20of%20Multiple%20Doses%20of%20PF-06305591

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Other Identifiers

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B5281002

Identifier Type: -

Identifier Source: org_study_id