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A Study To Assess Absorption Of Study Drug Dacomitinib (PF-00299804), Given As An Oral Tablet Compared To An Intravenous Infusion In Healthy Volunteers

NCT ID: NCT01796327

Last Updated: 2015-10-08

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

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-06-30

Brief Summary

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This study aims to determine the proportion of study drug dacomitinib or PF-00299804, that is taken up from the digestive tract into the body when given as an oral tablet compared with that taken up by an intravenous dose.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment

Dacomitinib will be administered as a single oral dose and as an intravenous infusion

Group Type EXPERIMENTAL

dacomitinib oral

Intervention Type DRUG

Dacomitinib 45 mg oral tablet

dacomitinib intravenous

Intervention Type DRUG

Dacomitinib 20 mg solution will be given as 1 hour intravenous infusion

Interventions

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dacomitinib oral

Dacomitinib 45 mg oral tablet

Intervention Type DRUG

dacomitinib intravenous

Dacomitinib 20 mg solution will be given as 1 hour intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male or 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 (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Treatment with an investigational drug within 3 months or 5 half-lives preceding the first dose of study medication, whichever is longer.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* Any known allergies or sensitivity to drug excipients.
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

Ruddington Fields, Nottingham, United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7471046

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

Other Identifiers

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A7471046

Identifier Type: -

Identifier Source: org_study_id

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