Bioavailability Study Of PF-00868554 Administered As 3x250mg Oral Tablets (Wet Granulate, 3x250mg Oral Tablets (Dry Granulate) And 750mg Solution Under Fed State

This study is currently recruiting participants.

Verified by Pfizer, May 2009

First Received: March 12, 2009 Last Updated: May 6, 2009 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00861458

Purpose

This study will test two different formulations. The results will be used to select formulation for phase 3.

Condition	Intervention	Phase
Hepatitis C Virus	Drug: Pharmacokinetics	Phase I

MedlinePlus related topics: Hepatitis Hepatitis C

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Open Label, Single Group Assignment, Bio-availability Study
Official Title:	A Phase 1, Open-Label, Randomized, 3-Way Crossover Study In Healthy Subjects To Estimate The Pharmacokinetics Of PF-00868554 Administered As 3x250mg Oral Tablets (Wet Granulate, 3x250mg Oral Tablets (Dry Granulate) And 750mg Solution Under Fed State

Further study details as provided by Pfizer:

Primary Outcome Measures:

AUC inf, Cmax [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	April 2009
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PF-00868554: Experimental	Drug: Pharmacokinetics Single dose of 750 mg PF-00868554 as a solution and tablets.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy volunteers.

Exclusion Criteria:

Standard for healthy volunteers.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00861458

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

Belgium
Pfizer Investigational Site	Recruiting
Bruxelles, Belgium, 1070

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A8121010
Study First Received:	March 12, 2009
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00861458 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases

Malnutrition
Hepatitis, Viral, Human
Healthy
Hepatitis C

Additional relevant MeSH terms:

Virus Diseases
Hepatitis
RNA Virus Infections
Liver Diseases

Digestive System Diseases
Flaviviridae Infections
Hepatitis, Viral, Human
Hepatitis C

ClinicalTrials.gov processed this record on May 07, 2009