MedDataX Logo

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

NCT ID: NCT01462851

Last Updated: 2012-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Single Dose Study Of PF-06291874 In Healthy Adult Subjects

NCT01499017

Healthy
TERMINATED PHASE1

A Study To Observe Safety And Blood Concentrations Of PF-04995274 During And Following the Administration of Multiple Doses Of PF-04995274 In Healthy Adult And Healthy Elderly Volunteers.

NCT01169714

Healthy
COMPLETED PHASE1

A Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Volunteers

NCT01897142

Healthy
COMPLETED PHASE1

A Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-06282999 Administered Orally In Healthy Adult Subjects

NCT01626976

Healthy
COMPLETED PHASE1

A Study To Evaluate The Safety, Tolerability And Plasma Drug Levels Following A Single Dose Of PF-04995274 In Healthy Adult Volunteers

NCT01091272

Healthy
COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dose Escalation

Ascending doses in healthy volunteers

Group Type EXPERIMENTAL

PF-05297909 25 mg

Intervention Type DRUG

Single oral (PO) dose, PF-05297909 25 mg

PF-05297909 100 mg

Intervention Type DRUG

Single oral (PO) dose, PF-05297909 100 mg

PF-05297909 250 mg

Intervention Type DRUG

Single oral (PO) dose, PF-05297909 250 mg

PF-05297909 525 mg

Intervention Type DRUG

Single oral (PO) dose, PF-05297909 525 mg

Part 2: CSF PKPD

Pharmacokinetic and pharmacodynamic cerebrospinal fluid assessment

Group Type EXPERIMENTAL

PF-05297909 525 mg

Intervention Type DRUG

Single oral (PO) dose, 525 mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PF-05297909 25 mg

Single oral (PO) dose, PF-05297909 25 mg

Intervention Type DRUG

PF-05297909 100 mg

Single oral (PO) dose, PF-05297909 100 mg

Intervention Type DRUG

PF-05297909 250 mg

Single oral (PO) dose, PF-05297909 250 mg

Intervention Type DRUG

PF-05297909 525 mg

Single oral (PO) dose, PF-05297909 525 mg

Intervention Type DRUG

PF-05297909 525 mg

Single oral (PO) dose, 525 mg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Glendale, California, United States

Site Status

Pfizer Investigational Site

New Haven, Connecticut, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3941001&StudyName=A%20Study%20To%20Observe%20Safety%20And%20Concentrations%20Of%20PF-05297909%20And%20Proteins%20In%20Both%20Blood%20And%20Cerebrospinal%20Fluid%20After%20A%20Single%20Dose%20O

To obtain contact information for a study center near you, click here.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B3941001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study To Characterize Mass Balance, Absolute Bioavailability, Fraction Absorbed And Pharmacokinetics Of 14C PF-06882961
NCT04495140 COMPLETED PHASE1
To Evaluate Safety, Tolerability, Plasma Drug Levels And Other Biological Effects In Healthy Volunteers
NCT01045863 TERMINATED PHASE1
A Study To Understand Safety And Plasma Concentrations Of PF-06669571 During And Following The Oral Administration Of Single And Multiple Doses Of PF-06669571 In Healthy Volunteers Under Fasted And Fed Conditions
NCT02184429 COMPLETED PHASE1
A Study To Observe Safety And Blood Concentrations Of PF-06649751 During And Following The Oral Administration Of Multiple Doses Of PF-06649751 In Healthy Adult Western and Japanese Volunteers
NCT02066909 COMPLETED PHASE1
A Phase 1 Study To Evaluate The Safety And Tolerability Of PF-06252616 In Healthy Subjects
NCT01616277 COMPLETED PHASE1
Study to Investigate the Mass Balance, Metabolism, and Excretion of [14C]-PF-07304814 in Healthy Participants
NCT05050682 COMPLETED PHASE1
A Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Multiple Oral Doses Of PF-04895162
NCT01691274 COMPLETED PHASE1
A Study to Learn About the Study Medicine PF-07853578 and How it Acts in the Bodies of Healthy Adults
NCT05890105 COMPLETED PHASE1
A Study To Evaluate the Safety, Tolerability, And Pharmacokinetics Of PF-06266047 In Healthy Adult Subjects
NCT02539550 COMPLETED PHASE1
A Study To Observe Safety And Blood Concentrations Of PF-06412562 During And Following The Oral Administration Of Multiple Doses Of PF-06412562 In Healthy Adult Volunteers
NCT01959594 COMPLETED PHASE1
A Study to Learn How the Study Medicine PF-07899895 Are Tolerated and Act in the Body of Healthy Adults
NCT06137729 TERMINATED PHASE1
Single Dose, Repeated Dose, and Conditional Food Effect Study of PF-05221304 in Healthy Subjects
NCT02871037 COMPLETED PHASE1
Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Doses Of PF-04958242 In Healthy Volunteers
NCT02228395 COMPLETED PHASE1
Single Dose Study of PF-05230907 in Healthy Japanese Subjects
NCT02537002 COMPLETED PHASE1
A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04629991 in Healthy Volunteers
NCT00797342 COMPLETED PHASE1
Single Dose Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06291874 In Healthy Adult Subjects
NCT01794364 COMPLETED PHASE1
First In Human, Single Escalating Oral Dose Study Of PF-06882961 In Healthy Adult Subjects
NCT03309241 COMPLETED PHASE1
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of PF-06852231 in Healthy Subjects
NCT03217604 COMPLETED PHASE1
Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Oral Pf-06650833 In Healthy Subjects
NCT02485769 COMPLETED PHASE1
Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of Compound PF-06823859
NCT02766621 COMPLETED PHASE1
A Study To Look At Safety And Blood Concentrations After Multiple Doses Of PF-03382792 In Healthy Elderly Individuals
NCT01089738 WITHDRAWN PHASE1
Single Dose Study to Assess the Safety, Tolerability and Pharmacokinetics(PK) of PF-06865571
NCT03092232 COMPLETED PHASE1
A Study to Learn About the Study Medicine (PF-07293893) at Different Dose Levels in Healthy Adults
NCT05907395 COMPLETED PHASE1
A Single Dose Crossover Study In Healthy Subjects To Evaluate Different Formulations Of PF-06882961
NCT03492697 COMPLETED PHASE1
OPEN LABEL, 2-PERIOD STUDY, TO COMPARE BIO-AVAILABILITY OF 2 DIFFERENT FORMULATIONS OF PF-05221304 IN HEALTHY ADULTS
NCT03871439 COMPLETED PHASE1