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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01298505
First received: February 2, 2011
Last updated: February 16, 2011
Last verified: February 2011
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01298505     History of Changes
Other Study ID Numbers: B0711006
Study First Received: February 2, 2011
Last Updated: February 16, 2011
Health Authority: Singapore: Health Sciences Authority

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

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

ClinicalTrials.gov processed this record on September 18, 2014