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Evaluation Of The Potential Effect That The Administration Of Food Or Antacid Medication May Have In The Oral Absorption Of Dacomitinib (PF-00299804)

NCT ID: NCT01702506

Last Updated: 2013-12-18

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-01-31

Brief Summary

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Evaluation of the potential effect that the administration of food or antacid medication may have in the oral absorption of dacomitinib relative to the administration of dacomitinib in absence of food or antacid medication

Detailed Description

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Conditions

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Healthy Volunteers

Keywords

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Dacomitinib PF-00299804 fed fasted antacid relative Bioavailability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Fasted

Dacomitinib administered under fasted conditions

Group Type EXPERIMENTAL

dacomitinib fasted

Intervention Type DRUG

Overnight fasted subjects will receive a single 45 mg dose of dacomitinib

Fed

Dacomitinib administered under fed conditions

Group Type EXPERIMENTAL

dacomitinib fed

Intervention Type DRUG

Subjects will receive a single 45 mg dose of dacomitinib with a high calorie high fat meal

Antacid

Dacomitinib administered under antacid treatment

Group Type EXPERIMENTAL

dacomitinib+antacid

Intervention Type DRUG

Subjects will receive a single 45 mg dose of dacomitinib when there are treated with rabeprazole

Interventions

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dacomitinib fasted

Overnight fasted subjects will receive a single 45 mg dose of dacomitinib

Intervention Type DRUG

dacomitinib fed

Subjects will receive a single 45 mg dose of dacomitinib with a high calorie high fat meal

Intervention Type DRUG

dacomitinib+antacid

Subjects will receive a single 45 mg dose of dacomitinib when there are treated with rabeprazole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects including males between the ages of 18 and 55 years. Females of non childbearing potential .
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* An informed consent document signed and dated by the subject.

Exclusion Criteria

* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement) or the appropriate time based on the elimination characteristics of the study medication.
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

References

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Ruiz-Garcia A, Masters JC, Mendes da Costa L, LaBadie RR, Liang Y, Ni G, Ellery CA, Boutros T, Goldberg Z, Bello CL. Effect of food or proton pump inhibitor treatment on the bioavailability of dacomitinib in healthy volunteers. J Clin Pharmacol. 2016 Feb;56(2):223-30. doi: 10.1002/jcph.588. Epub 2015 Oct 9.

Reference Type DERIVED
PMID: 26179237 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7471015&StudyName=Evaluation%20Of%20The%20Potential%20Effect%20That%20The%20Administration%20Of%20Food%20Or%20Antacid%20Medication%20May%20Have%20In%20The%20Oral%20Absorption%20Of%20Dacomitini

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Other Identifiers

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A7471015

Identifier Type: -

Identifier Source: org_study_id