A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04629991 in Healthy Volunteers
- Registration Number
- NCT00797342
- Lead Sponsor
- Pfizer
- Brief Summary
This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04629991 in healthy subjects. Dose exploration will proceed in a step-wise manner, beginning with low doses not expected to have significant biological effects and proceeding to doses approximating or exceeding the anticipated therapeutic level. Doses to be explored may be limited by tolerability, and will not exceed levels previously shown to be tolerable in animals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria
- Healthy non-smoking men and women
- body mass index 18-30 kg/m2
Exclusion Criteria
- Women must not be able to have children
- no current infections
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description first of three dosing cohorts PF-04629991 - second of three dosing cohorts PF-04629991 - third of three dosing cohorts PF-04629991 -
- Primary Outcome Measures
Name Time Method Pharmacokinetics e.g., maximum concentration and area under the concentration-time curve 2 weeks Safety/Tolerability e.g., reported adverse events and safety laboratory studies 2 weeks Pharmacodynamics e.g., changes in a peripheral blood biomarker 2 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇧🇪Bruxelles, Belgium