Trials / Completed
CompletedNCT00651027
Study To Assess The Impact Of Hepatic Impairment On The Safety, Tolerability And Pharmacokinetics Of Single-Dose 200 Mg Of PF-868554
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years – 62 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PF-868554 | 200 mg, Child-Pugh Class A |
| DRUG | PF-868554 | 200 mg, Child-Pugh Class B |
| DRUG | PF-868554 | 200 mg, healthy volunteers |
Timeline
- Start date
- 2008-02-01
- Primary completion
- 2008-09-01
- Completion
- 2008-09-01
- First posted
- 2008-04-02
- Last updated
- 2014-01-03
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00651027. Inclusion in this directory is not an endorsement.