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A Phase 1, Randomized Investigator-And-Subject-Blind, Sponsor Open, Placebo Controlled Two-Part Study To Characterize The Pharmacokinetics And Pharmacodynamics Of Single Doses Of Pf-05297909 In Healthy Adult Subjects
This study is designed to observe the safety and concentrations of PF-05297909 and proteins in both blood and cerebrospinal fluid after a single dose of PF-05297909 in healthy adults.
Details
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 51 |
| Start date | 2011-09 |
| Completion | 2012-02 |
Conditions
- Healthy
Interventions
- PF-05297909 25 mg
- PF-05297909 100 mg
- PF-05297909 250 mg
- PF-05297909 525 mg
- PF-05297909 525 mg
Primary outcomes
- Plasma area under the curve last (AUClast) pharmacokinetic parameter — Day 1 to Day 3
- Plasma apparent clearance (CL/F) pharmacokinetic parameter — Day 0 to Day 3
- Clinical potency of PF 05297909 for reduction in CSF levels of Abeta40, Abeta42, and/or AbetaX via estimation of the IC50 from a population PK/PD (PPK/PD) model — Day 0 to Day 3
- Plasma area under the curve infinity (AUCinf) pharmacokinetic parameter — Day 1 to Day 3
- Plasma half-life (t1/2) pharmacokinetic parameter — Day 1 to Day 3
- Plasma apparent volume of distribution (Vz/F) pharmacokinetic parameter — Day 1 to Day 3
Countries
United States