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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: December 17, 2008
Last updated: November 30, 2009
Last verified: November 2009
To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of PF-04878691.

Condition Intervention Phase
Hepatitis C Virus Drug: PF-04878691 3mg Drug: PF-04878691 6mg Drug: PF-04878691 9mg Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To assess the safety and toleration of multiple ascending oral doses of PF-04878691 [ Time Frame: 3 weeks ]

Secondary Outcome Measures:
  • To assess the pharmacokinetics and pharmacodynamics with regards to specific biomarkers of immune stimulation of PF-04878691 [ Time Frame: 3 weeks ]

Enrollment: 24
Study Start Date: January 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-04878691 Drug: PF-04878691 3mg
Oral solution, 3mg, twice weekly, 2 weeks
Drug: PF-04878691 6mg
Oral solution, 6mg, twice weekly, 2 weeks
Drug: PF-04878691 9mg
Oral solution, 9mg, twice weekly, 2 weeks


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   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:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00810758

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00810758     History of Changes
Other Study ID Numbers: B1201002
Study First Received: December 17, 2008
Last Updated: November 30, 2009

Keywords provided by Pfizer:
Toll-like receptor 7
Multiple oral dose escalation study of PF-04878691

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Liver Diseases
Digestive System Diseases processed this record on September 21, 2017