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A Study To Investigate The Safety And Toleration Of Multiple Oral Doses Of PF-03654764 In Combination With Fexofenadine In Healthy Subjects

This study has been terminated.
(This study was stopped due to lack of evidence for clinical efficacy.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01298505
First Posted: February 17, 2011
Last Update Posted: February 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
The purpose of this study in healthy people is to investigate the safety, toleration and time course of PF-03654764 in the blood, following multiple doses given by mouth together with fexofenadine.

Condition Intervention Phase
Healthy Drug: PF-03654764 2.5mg plus fexofenadine 60mg Drug: PF-03654764 5mg plus fexofenadine 60mg Drug: placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase 1 Double-Blind (3rd Party Open), Randomized, Placebo-Controlled Study To Investigate The Safety And Toleration Of Multiple Oral Doses Of PF-03654764 In Combination With Fexofenadine In Healthy Subjects.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of participants with adverse events as a measure of safety and tolerability. [ Time Frame: 30 days ]
    Blood and urine safety tests and physical examinations will be used to assess the adverse events.


Secondary Outcome Measures:
  • Plasma concentrations of PF-03654764 will be measured. [ Time Frame: 7 days ]

Enrollment: 0
Study Start Date: June 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-03654764 2.5mg plus fexofenadine 60mg Drug: PF-03654764 2.5mg plus fexofenadine 60mg
PF-03654764 2.5mg plus fexofenadine 60mg twice daily for 7 days
Experimental: PF-03654764 5mg plus fexofenadine 60mg Drug: PF-03654764 5mg plus fexofenadine 60mg
PF-03654764 5mg plus fexofenadine 60mg twice daily for 7 days
Placebo Comparator: placebo Drug: placebo
placebo given twice daily for 7 days

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • A positive urine drug screen.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01298505


Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01298505     History of Changes
Other Study ID Numbers: B0711006
First Submitted: February 2, 2011
First Posted: February 17, 2011
Last Update Posted: February 17, 2011
Last Verified: February 2011

Keywords provided by Pfizer:
Phase 1 multiple dose safety toleration fexofenadine

Additional relevant MeSH terms:
Fexofenadine
Terfenadine
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs