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

This study has been terminated.
(See Detailed Description)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00875628
First received: April 1, 2009
Last updated: October 21, 2009
Last verified: October 2009
  Purpose

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


Condition Intervention Phase
Healthy Volunteers
Drug: PF-00868554 or Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Plasma PF-00868554 concentrations [ Time Frame: Day 1-Day 17 ] [ Designated as safety issue: Yes ]
  • Urine PF-00868554 concentrations [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: Yes ]
  • Adverse event monitoring and Physical examination [ Time Frame: Day 0-Day 17 ] [ Designated as safety issue: No ]
  • ECGs and vital signs (Blood pressure and Pulse rate) [ Time Frame: Day 1-Day 17 ] [ Designated as safety issue: Yes ]
  • Clinical safety laboratory tests [ Time Frame: Day 0, Day 7, and Day 17 ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: April 2009
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Cohort 2
PF-00868554 300 mg or placebo
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
Cohort 3
PF-00868554 600 mg or placebo
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00875628

Locations
United States, California
Pfizer Investigational Site
Glendale, California, United States, 91206
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00875628     History of Changes
Other Study ID Numbers: A8121018
Study First Received: April 1, 2009
Last Updated: October 21, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Japanese Healthy volunteers HCV pharmacokinetics PF-00868554 filibuvir

ClinicalTrials.gov processed this record on April 14, 2014