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 has been completed.

First Received: March 12, 2009 Last Updated: July 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

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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis C

Further study details as provided by Pfizer:

Primary Outcome Measures:

Secondary Outcome Measures:

Enrollment:	14
Study Start Date:	April 2009
Study Completion Date:	June 2009
Primary Completion Date:	June 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

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

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

Locations

Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A8121010
Study First Received:	March 12, 2009
Last Updated:	July 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 September 10, 2009