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See Detailed Description
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Investigation of safety, tolerability, and pharmacokinetics of PF-00868554 following multiple oral administrations of PF-00868554 in Japanese healthy adult volunteers.
Study A8121018 was prematurely discontinued due to FDA instructions stating that Study A8121018 could not be performed under US IND 78,910, which was provided by the meeting on August 13, 2009. And then the termination was decided by Pfizer on September 8, 2009 prior to subject dosing with PF-00868554. There were no safety concerns regarding the study in the decision to terminate the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Other | PF-00868554 100 mg or placebo |
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| Cohort 2 | Other | PF-00868554 300 mg or placebo |
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| Cohort 3 | Other | PF-00868554 600 mg or placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-00868554 or Placebo | Drug | Dosage Form: Oral solution Dosage: PF-00868554 100 mg or placebo under fasting conditions Frequency: BID (twice daily) Duration: 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma PF-00868554 concentrations | Day 1-Day 17 | |
| Urine PF-00868554 concentrations | Day 1 and Day 14 | |
| Adverse event monitoring and Physical examination | Day 0-Day 17 | |
| ECGs and vital signs (Blood pressure and Pulse rate) | Day 1-Day 17 | |
| Clinical safety laboratory tests | Day 0, Day 7, and Day 17 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Glendale | California | 91206 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| C550357 | filibuvir |
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| PF-00868554 or Placebo | Drug | Dosage Form: Oral solution Dosage: PF-00868554 300 mg or placebo under fasting conditions Frequency: BID (twice daily) Duration: 14 days |
|
| PF-00868554 or Placebo | Drug | Dosage Form: Tablet Dosage: PF-00868554 600 mg or placebo under fed conditions Frequency: BID (twice daily) Duration: 14 days |
|