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

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

Investigation of safety, tolerability, and pharmacokinetics of PF-00868554 following multiple oral administrations of PF-00868554 in Japanese healthy adult volunteers.

Study Overview

• Status: Terminated
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: PF-00868554 or Placebo; Drug: PF-00868554 or Placebo; Drug: PF-00868554 or Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: April 1, 2009
• First Submitted That Met QC Criteria: April 2, 2009
• First Posted (Estimate): April 3, 2009

Study Record Updates

• Last Update Posted (Estimate): October 22, 2009
• Last Update Submitted That Met QC Criteria: October 21, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: Japanese Healthy volunteers HCV pharmacokinetics PF-00868554 filibuvir
• Other Study ID Numbers: A8121018