Study to Investigate the Safety, Tolerability, Pharmacokinetics of PF-06305591 in Healthy Male and Female Subjects
- Registration Number
- NCT01747941
- Lead Sponsor
- Pfizer
- Brief Summary
The study is designed to test safety tolerability and PK of single oral ascending doses of PF-06305591,
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- healthy young subjects
- aged 18-55
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 the time of dosing).
- Pregnant or nursing females; females of childbearing potential.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cohort 2 Placebo Single ascending oral doses in fasted conditions Cohort 3 PF-06305591 Single ascending oral doses in fed conditions Cohort 1 PF-06305591 Single ascending oral doses in fasted conditions Cohort 1 Placebo Single ascending oral doses in fasted conditions Cohort 2 PF-06305591 Single ascending oral doses in fasted conditions Cohort 3 Placebo Single ascending oral doses in fed conditions
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) 72 hr
- Secondary Outcome Measures
Name Time Method Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] 72 hr
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇧🇪Brussels, Belgium