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

A Phase 1, Randomized, Placebo Controlled, Blinded (3rd Party Open), Sequential, Multiple-Dose Escalation Study To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04878691 In Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00810758

Enrollment

Registered

2008-12-18

Start date

2009-01-31

Completion date

2009-11-30

Last updated

2009-12-01

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

Conditions

Hepatitis C Virus

Keywords

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

Brief summary

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

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

* 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.

Design outcomes

Primary

Measure	Time frame
To assess the safety and toleration of multiple ascending oral doses of PF-04878691	3 weeks

Secondary

Measure	Time frame
To assess the pharmacokinetics and pharmacodynamics with regards to specific biomarkers of immune stimulation of PF-04878691	3 weeks

Countries

United States

Outcome results

None listed

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