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
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 April 17, 2014