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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00875628

Enrollment

Registered

2009-04-03

Start date

2009-04-30

Completion date

2009-04-30

Last updated

2009-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Japanese Healthy volunteers HCV pharmacokinetics PF-00868554 filibuvir

Brief summary

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

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.

Interventions

DRUGPF-00868554 or Placebo

Dosage Form: Oral solution Dosage: PF-00868554 100 mg or placebo under fasting conditions Frequency: BID (twice daily) Duration: 14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026