You are here

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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bruxelles, , B-1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01702506
Pfizer
Completed
Evaluation Of The Potential Effect That The Administration Of Food Or Antacid Medication May Have In The Oral Absorption Of Dacomitinib (PF-00299804)

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

ClinicalTr[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
Evaluation Of The Potential Effect That The Administration Of Food Or Antacid Medication May Have In The Oral Absorption Of Dacomitinib (PF-00299804)
Phase 1 Three Period Crossover Study To Evaluate The Effect Of Food And Antacids On The Pharmacokinetics, Safety & Tolerability Of PF-299,804 In Healthy Volunteers Who Have Received PF-299,804
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
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy Volunteers
  • Drug: dacomitinib fasted
    Overnight fasted subjects will receive a single 45 mg dose of dacomitinib
  • Drug: dacomitinib fed
    Subjects will receive a single 45 mg dose of dacomitinib with a high calorie high fat meal
  • Drug: dacomitinib+antacid
    Subjects will receive a single 45 mg dose of dacomitinib when there are treated with rabeprazole
  • Experimental: Fasted
    Dacomitinib administered under fasted conditions
    Intervention: Drug: dacomitinib fasted
  • Experimental: Fed
    Dacomitinib administered under fed conditions
    Intervention: Drug: dacomitinib fed
  • Experimental: Antacid
    Dacomitinib administered under antacid treatment
    Intervention: Drug: dacomitinib+antacid
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
January 2013
January 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01702506
A7471015
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now