NCT00810758

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2008

Completed
14 days until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

December 1, 2009

Status Verified

November 1, 2009

Enrollment Period

10 months

First QC Date

December 17, 2008

Last Update Submit

November 30, 2009

Conditions

Hepatitis C Virus

Keywords

HCVToll-like receptor 7Multiple oral dose escalation study of PF-04878691

Outcome Measures

Primary Outcomes (1)

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

    3 weeks

Secondary Outcomes (1)

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

    3 weeks

Study Arms (1)

PF-04878691

EXPERIMENTAL
Drug: PF-04878691 3mgDrug: PF-04878691 6mgDrug: PF-04878691 9mg

Interventions

PF-04878691 3mgDRUG

Oral solution, 3mg, twice weekly, 2 weeks

PF-04878691
PF-04878691 6mgDRUG

Oral solution, 6mg, twice weekly, 2 weeks

PF-04878691
PF-04878691 9mgDRUG

Oral solution, 9mg, twice weekly, 2 weeks

PF-04878691

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

MeSH Terms

Conditions

Hepatitis C

Interventions

N-(4-(4-amino-2-ethyl-1H-imidazo(4,5c)quinolin-1-yl)butyl)methanesulfonamide

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 17, 2008

First Posted

December 18, 2008

Study Start

January 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

December 1, 2009

Record last verified: 2009-11

Locations

US(1)