A Phase 1 Multiple-Dose Escalation and Single Dose (Tablet) Study of PF-04171327 in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT00812825
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics (how the drug effects certain target sites of activity in the body) of escalating doses of oral PF-04171327 in healthy volunteers for 14 days (Part 1). Part 2 will evaluate the pharmacokinetics of a single 10 mg dose of the PF-04171327 tablet in healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
Inclusion Criteria
- Healthy males between 18 and 55 years, inclusive.
- Healthy females between 18 and 44 years, inclusive.
Exclusion Criteria
- Evidence or history of clinically significant disease;
- Post-menopausal women;
- History of intolerance or significant adverse effects with glucocorticoids. therapy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prednisolone Prednisolone - Placebo Placebo - Solution Placebo Placebo Solution - PF-04171327 Tablet PF-04171327 Tablet - PF-04173127 PF-04171327 -
- Primary Outcome Measures
Name Time Method Safety and tolerability of multiple doses of PF-04171327 14 days Determination of pharmacokinetic parameters of PF-04171327 after multiple doses 14 days Assessment of the pharmacodynamic effects of PF-04171327 on chemical and metabolic biomarkers 14 days Evaluation of the pharmacokinetic parameters of a single 10 mg dose of PF-04171327 tablet 1 day
- Secondary Outcome Measures
Name Time Method To characterize the pharmacodynamic effects of prednisolone 14 days
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇧🇪Bruxelles, Belgium