Study To Assess The Impact Of Hepatic Impairment On The Safety, Tolerability And Pharmacokinetics Of Single-Dose 200 Mg Of PF-868554

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00651027
• Collaborator: (none)
• Enrollment: 24
• Locations: 3
• Arms: 3
• Duration (Months): 7
• Patients Per Site: 8
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

The metabolism of PF-00868554 is primarily mediated by CYP3A, and it is anticipated that hepatic impairment will modify PF-00868554 plasma concentrations. Hence, it is important to determine the impact of varying degrees of hepatic impairment on the pharmacokinetics, safety and toleration of 200 mg PF-00868554 administered as a single-dose.

Condition or Disease	Intervention/Treatment	Phase
HEPATITIS C (HCV)	Drug: PF-868554; Drug: PF-868554; Drug: PF-868554	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Label Study, To Evaluate The Pharmacokinetics, Safety And Toleration Of A Single Oral Dose Of Pf-00868554 In Subjects With Hepatic Impairment To Subjects With Normal Hepatic Function
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Drug: PF-868554; 200 mg, Child-Pugh Class A
Experimental: B	Drug: PF-868554; 200 mg, Child-Pugh Class B
Experimental: C 200 mg	Drug: PF-868554; 200 mg, healthy volunteers

Outcome Measures

Primary Outcome Measures

1. PK parameters [8 day]

Secondary Outcome Measures

1. safety and tolerability [8days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 62 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male or females subjects of non-childbearing potential between the ages of 18 and 62 years of age, inclusive;

• Body Mass Index (BMI) of approximately 18 to 35 kg/m2; and a total body weigh >50 kg (110 lbs);

Exclusion Criteria:

• Subjects with Class C classification (Severe - Child-Pugh Scores greater than 10);

• Severe ascites and/or pleural effusion;

• Had a transplanted kidney, heart or liver;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Anaheim	California	United States	92801
2	Pfizer Investigational Site	Anaheim	California	United States	92804
3	Pfizer Investigational Site	Miami	Florida	United States	33169

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00651027
• Other Study ID Numbers: A8121004
• First Posted: Apr 2, 2008
• Last Update Posted: Jan 3, 2014
• Last Verified: Jan 1, 2014

• Additional relevant MeSH terms: Hepatitis C

Study Results

No Results Posted as of Jan 3, 2014