A Study To Observe Safety And Concentrations Of PF-05297909 And Proteins In Both Blood And Cerebrospinal Fluid After A Single Dose Of PF-05297909 In Healthy Adults

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-05297909 525 mg; Drug: PF-05297909 100 mg; Drug: PF-05297909 25 mg; Drug: PF-05297909 250 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01462851

B3941001

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• For Healthy adult volunteers: healthy male and/or female subjects of non child bearing 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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 2 patient groups

Dose Escalation

Experimental group

Description:

Ascending doses in healthy volunteers

Treatment:

Drug: PF-05297909 525 mg

Drug: PF-05297909 525 mg

Drug: PF-05297909 100 mg

Drug: PF-05297909 25 mg

Drug: PF-05297909 250 mg

Part 2: CSF PKPD

Experimental group

Description:

Pharmacokinetic and pharmacodynamic cerebrospinal fluid assessment

Treatment:

Drug: PF-05297909 525 mg

Drug: PF-05297909 525 mg