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NCT01298505 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01298505
Other study ID # B0711006
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date June 4, 2010
Est. completion date June 4, 2010

Study information
Verified date February 2019
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 36
Est. completion date June 4, 2010
Est. primary completion date June 4, 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 55 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• PF-03654764 2.5mg plus fexofenadine 60mg
PF-03654764 2.5mg plus fexofenadine 60mg twice daily for 7 days
• PF-03654764 5mg plus fexofenadine 60mg
PF-03654764 5mg plus fexofenadine 60mg twice daily for 7 days
• placebo
placebo given twice daily for 7 days

Locations
Country Name City State
Singapore Pfizer Clinical Research Unit Singapore

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with adverse events as a measure of safety and tolerability. 30 days
Secondary Plasma concentrations of PF-03654764 will be measured. 7 days
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