A Study To Investigate Safety, Tolerability, And Pharmacokinetics Of PF-00868554 In Japanese Healthy Adult Volunteers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase 1, Randomized, Double Blind (Sponsor-Open), Placebo Controlled, Dose Escalation, Multiple Dose Study To Investigate Safety, Tolerability, And Pharmacokinetics Of PF-00868554 In Japanese Healthy Adult Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: PF-00868554 or Placebo
* Drug: PF-00868554 or Placebo
* Drug: PF-00868554 or Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female Japanese subjects between the ages of 18 and 55 years. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs). Exclusion Criteria: Male subjects with a history of subfertility/infertility and other conditions that in the opinion of the investigator may affect fertility. Exposure within the previous three months to a drug known to have a negative effect on skeletal muscle or reproductive organs. Pregnant or nursing females; females of childbearing potential.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cohort 1<br>PF-00868554 100 mg or placebo | Drug: PF-00868554 or Placebo<br>* Dosage Form: Oral solution Dosage: PF-00868554 100 mg or placebo under fasting conditions Frequency: BID (twice daily) Duration: 14 days<br>|
| Other: Cohort 2<br>PF-00868554 300 mg or placebo | Drug: PF-00868554 or Placebo<br>* Dosage Form: Oral solution Dosage: PF-00868554 300 mg or placebo under fasting conditions Frequency: BID (twice daily) Duration: 14 days<br>|
| Other: Cohort 3<br>PF-00868554 600 mg or placebo | Drug: PF-00868554 or Placebo<br>* Dosage Form: Tablet Dosage: PF-00868554 600 mg or placebo under fed conditions Frequency: BID (twice daily) Duration: 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Japanese Healthy volunteers HCV pharmacokinetics PF-00868554 filibuvir