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CompletedNCT00810758Updated Dec 1, 2009

Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04878691

A Phase 1 interventional study of PF-04878691 3mg and PF-04878691 6mg in Hepatitis C Virus, sponsored by Pfizer. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-12-01.

Sponsored by Pfizer · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of PF-04878691.

02

Conditions studied

  • Hepatitis C Virus

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Keywords

  • HCV
  • Toll-like receptor 7
  • Multiple oral dose escalation study of PF-04878691
03

In context

Hepatitis C

2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.

This study's enrollment of 24 is below the median of 79 across 1,633 interventional studies indexed under Hepatitis C.

Browse Hepatitis C studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy male and/or female subjects between the ages of 18-55, inclusive.
  • Body Mass Index (BMI) of 18-30 kg/m2; total body weight >50kg (110lbs).

Exclusion criteria

Exclusion Criteria:

  • Pregnant or nursing females.
  • Females of child-bearing potential.
  • Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic or autoimmune disease or clinical findings at screening.
  • Smoking within the previous 6 months.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    PF-04878691

    Drug: PF-04878691 3mg · Drug: PF-04878691 6mg · Drug: PF-04878691 9mg

Interventions

  • DrugPF-04878691 3mg

    Oral solution, 3mg, twice weekly, 2 weeks

  • DrugPF-04878691 6mg

    Oral solution, 6mg, twice weekly, 2 weeks

  • DrugPF-04878691 9mg

    Oral solution, 9mg, twice weekly, 2 weeks

06

What researchers measure

Primary outcomes

  1. To assess the safety and toleration of multiple ascending oral doses of PF-04878691

    Time frame: 3 weeks

Secondary outcomes

  1. To assess the pharmacokinetics and pharmacodynamics with regards to specific biomarkers of immune stimulation of PF-04878691

    Time frame: 3 weeks

07

Study locations

1 site
  • Pfizer Investigational Site
    New Haven, Connecticut 06511, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00810758
Lead sponsor
Pfizer
First posted
Dec 18, 2008
Start date
Jan 2009
Primary completion
Nov 2009
Completion
Nov 2009
Last update
Dec 1, 2009

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.

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