Status:

COMPLETED

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

Lead Sponsor:

Pfizer

Conditions:

Healthy Volunteers

Eligibility:

All Genders

18-55 years

Phase:

PHASE1

Brief Summary

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 b...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

April 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2013

Estimated Enrollment :

14 Patients enrolled

Trial Details

Trial ID

NCT01796327

Start Date

April 1 2013

End Date

June 1 2013

Last Update

October 8 2015

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Pfizer Investigational Site

Ruddington Fields, Nottingham, United Kingdom, NG11 6JS