A Study To Investigate The Safety And Toleration Of Multiple Oral Doses Of PF-03654764 In Combination With Fexofenadine In Healthy Subjects
Phase 1
Terminated
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT01298505
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 36
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PF-03654764 5mg plus fexofenadine 60mg PF-03654764 5mg plus fexofenadine 60mg - PF-03654764 2.5mg plus fexofenadine 60mg PF-03654764 2.5mg plus fexofenadine 60mg - placebo placebo -
- Primary Outcome Measures
Name Time Method Number of participants with adverse events as a measure of safety and tolerability. 30 days
- Secondary Outcome Measures
Name Time Method Plasma concentrations of PF-03654764 will be measured. 7 days
Trial Locations
- Locations (1)
Pfizer Clinical Research Unit
🇸🇬Singapore, Singapore