A Phase 1 Investigator And Subject-Blind Study In Healthy Subjects To Evaluate The Pharmacodynamic Effects Of Single Doses Of PF-04995274 On Sapp-Alpha Concentrations In Cerebrospinal Fluid Using Serial Sampling Methodology
Overview
- Phase
- Phase 1
- Intervention
- PF-04995274
- Conditions
- Healthy
- Sponsor
- Pfizer
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Safety Endpoints (AE's, Vital signs, ECG, Clinical safety laboratory endpoints, Clinical examinations)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
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
Investigators
Eligibility 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.
Arms & Interventions
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
Intervention: PF-04995274
Cohort 2
Subjects will be receive single oral doses of PF-04995274 not exceeding 15mg or a placebo
Intervention: PF-04995274
Outcomes
Primary Outcomes
Safety Endpoints (AE's, Vital signs, ECG, Clinical safety laboratory endpoints, Clinical examinations)
Time Frame: duration of study
Cmax, Tmax, AUClast, AUCinf, and t1/2 of PF 04995274 and PF-05082547 in plasma, as the data permit
Time Frame: 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
Time Frame: 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
Time Frame: 8 hours post dose
Secondary Outcomes
- PK/PD model(8 hours post dose)