Study Stopped
This study was stopped due to lack of evidence for clinical efficacy.
A Study To Investigate The Safety And Toleration Of Multiple Oral Doses Of PF-03654764 In Combination With Fexofenadine In Healthy Subjects
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
1 other identifier
interventional
36
1 country
1
Brief Summary
The purpose of this study in heathy 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Jun 2010
1 active site
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
Study Start
First participant enrolled
June 4, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2010
CompletedFirst Submitted
Initial submission to the registry
February 2, 2011
CompletedFirst Posted
Study publicly available on registry
February 17, 2011
CompletedFebruary 11, 2019
February 1, 2019
Same day
February 2, 2011
February 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with adverse events as a measure of safety and tolerability.
30 days
Secondary Outcomes (1)
Plasma concentrations of PF-03654764 will be measured.
7 days
Study Arms (3)
PF-03654764 2.5mg plus fexofenadine 60mg
EXPERIMENTALPF-03654764 5mg plus fexofenadine 60mg
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
PF-03654764 2.5mg plus fexofenadine 60mg twice daily for 7 days
PF-03654764 5mg plus fexofenadine 60mg twice daily for 7 days
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Clinical Research Unit
Singapore, 188770, Singapore
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2011
First Posted
February 17, 2011
Study Start
June 4, 2010
Primary Completion
June 4, 2010
Study Completion
June 4, 2010
Last Updated
February 11, 2019
Record last verified: 2019-02