A Study To Evaluate Whether Food Affects The Plasma Drug Levels Of A 35 mg Single Dose Of PF-04447943 Taken Orally In Healthy Adult Participants

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00886093
First received: April 21, 2009
Last updated: June 29, 2009
Last verified: June 2009
  Purpose

The purpose of the study is to compare the plasma drug levels of PF-04447943 when taken as a 35 mg tablet after a high fat meal compared to when taken after fasting. Healthy adult volunteers will receive a single dose of the drug once when fasted and again when fed. The safety and tolerability of the drug will be monitored.


Condition Intervention Phase
Healthy
Drug: PF-04447943
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Phase 1, Open Label, Randomized, Single Dose, Cross-Over Study To Evaluate The Effect Of Food On PF-04447943 Pharmacokinetics In Healthy Adult Subjects

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Pharmacokinetic endpoints include plasma PF-04447943 area under the curve (AUC), maximum plasma concentration (Cmax) and time of maximum plasma concentration (Tmax). [ Time Frame: Up to 96 hours after drug administration ] [ Designated as safety issue: No ]
  • Safety endpoints include vital signs, ECGs, clinical laboratory tests, clinical evaluations and examinations, and adverse events. [ Time Frame: Up to 96 hours after drug administration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • No secondary outcomes [ Time Frame: No secondary outcomes ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: April 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1 Drug: PF-04447943
35 mg tablet of PF-04447943 taken in the fed state in Period 1 followed a week later by administration of the same tablet and dose taken in the fasted state in Period 2
Experimental: Sequence 2 Drug: PF-04447943
35 mg tablet of PF-04447943 taken in the fasted state in Period 1 followed a week later by administration of the same tablet and dose in the fed state in Period 2.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and/or female subjects, not of child bearing potential.
  • Age 18-55 inclusive
  • Total body weight >50 kg.

Exclusion Criteria:

  • Evidence or history of clinical significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic diseases
  • History of orthostatic blood pressure changes or orthostatic symptoms
  • Greater than 7 drinks of alcohol per week for women and greater than 14 drinks per week for men
  • Smoking more than 5 cigarettes per day
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886093

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00886093     History of Changes
Other Study ID Numbers: B0401006
Study First Received: April 21, 2009
Last Updated: June 29, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
pharmacokinetics, single dose, crossover, fed vs fasted state

ClinicalTrials.gov processed this record on September 18, 2014