Study In Healthy Subjects To Evaluate The Changes In The Protein sAPP-Alpha In Cerebrospinal Fluid Following A Single Oral Dose Of PF-04995274
Study Details
Study Description
Brief Summary
The primary purpose of the study is to evaluate the effect of PF-04995274 on cerebrospinal fluid levels of soluble Amyloid precursor protein fragments and Amyloid beta fragments following single oral dose in healthy volunteers. Safety and tolerability of PF-04995274 single dose administration in healthy volunteers will also be assessed as part of the objectives.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
The purpose of the study is to evaluate the effect of PF-04995274 on CSF levels of s-APP and Abeta fragments following single oral dose in healthy volunteers
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1 Subjects will be randomized to receive single oral doses of 0.1 mg, 10 mg, 15mg/ 40 mg PF-04995274 or a placebo |
Drug: PF-04995274
Subjects will be randomized to receive single oral doses of 0.1 mg, 10 mg, 15mg/ 40 mg PF-04995274 or a placebo
|
| Experimental: Cohort 2 Subjects will be receive single oral doses of PF-04995274 not exceeding 15mg or a placebo |
Drug: PF-04995274
Doses for cohort 2 will be decided based on an Interim analysis of data from cohort 1. The highest dose to be used in Cohort 2 not to exceed 15mg
|
Outcome Measures
Primary Outcome Measures
- Safety Endpoints (AE's, Vital signs, ECG, Clinical safety laboratory endpoints, Clinical examinations) [duration of study]
- Cmax, Tmax, AUClast, AUCinf, and t1/2 of PF 04995274 and PF-05082547 in plasma, as the data permit [upto 5 days post dose]
- Cmax, Tmax, AUClast, AUCinf, and t1/2 of PF 04995274 and PF-05082547 in cerebrospinal fluid, as the data permit [upto 8 hrs post dose]
- Cmax, Tmax, AUClast, AUCinf, and t1/2 of s-APP alpha and Abeta fragments in cerebrospinal fluid, as the data permit [8 hours post dose]
Secondary Outcome Measures
- PK/PD model [8 hours post dose]
Eligibility Criteria
Criteria
Inclusion Criteria:
- For all cohorts, healthy male and/or female subjects of nonchildbearing potential between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and heart 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).
-
Pregnant or nursing women; women of childbearing potential.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | New Haven | Connecticut | United States | 06511 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- B1661004