MedDataX Logo

A Study In Healthy Elderly People To Evaluate Safety, Toleration, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses Of PF-06743649

NCT ID: NCT02170012

Last Updated: 2015-03-17

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-09-30

Brief Summary

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

The purpose of this study in healthy elderly people is to evaluate safety, toleration and time course of plasma concentration of multiple oral doses of PF-06743649- The pharmacodynamic activity of PF-06743649 will also be assessed.

Related Clinical Trials

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

A Phase I, Multiple Dose Study of PF-04447943 in Healthy Elderly Volunteers

NCT00736528

Healthy Elderly
TERMINATED PHASE1

A Study In Healthy People To Evaluate Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of Multiple Oral Doses Of PF-06743649

NCT02151617

Healthy
COMPLETED PHASE1

A Study to Evaluate Safety, Toleration and Time Course of Plasma Concentration of Multiple Oral Doses of PF-06372865 in Healthy Subjects of Two AgeGroups, Aged 18-55 Years (Group 1) and Aged 56-75 Years (Group 2)

NCT02070289

Healthy
COMPLETED PHASE1

Study of Single and Multiple Ascending Doses of PF-07059013 in Healthy Adult Participants

NCT04323124

Healthy
TERMINATED PHASE1

Study in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06687234

NCT02711462

Healthy
TERMINATED 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 Elderly

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.

Cohort 1-PF-06743649 or placebo

Group Type EXPERIMENTAL

PF-06743649

Intervention Type DRUG

20 mg tablet once daily dosing for 14 days

Placebo

Intervention Type DRUG

Placebo tablet once daily dosing for 14 days

Cohort 2-PF-06743649 or placebo

Group Type EXPERIMENTAL

PF-06743649

Intervention Type DRUG

To be decided dose, tablet once daily dosing for 14 days

Placebo

Intervention Type DRUG

Placebo tablet once daily dosing for 14 days

Cohort 3-PF-06743649 or placebo

Group Type EXPERIMENTAL

PF-06743649

Intervention Type DRUG

To be decided dose, tablet once daily dosing for 14 days

Placebo

Intervention Type DRUG

Placebo tablet once daily dosing for 14 days

Cohort 4-PF-06743649 or placebo

Group Type EXPERIMENTAL

PF-06743649

Intervention Type DRUG

To be decided dose, tablet once daily dosing for 14 days

Placebo

Intervention Type DRUG

Placebo tablet once daily dosing for 14 days

Cohort 5-PF-06743649 or placebo

Group Type EXPERIMENTAL

PF-06743649

Intervention Type DRUG

To be decided dose, tablet once daily dosing for 14 days

Placebo

Intervention Type DRUG

Placebo tablet once daily dosing for 14 days

Interventions

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

PF-06743649

20 mg tablet once daily dosing for 14 days

Intervention Type DRUG

Placebo

Placebo tablet once daily dosing for 14 days

Intervention Type DRUG

PF-06743649

To be decided dose, tablet once daily dosing for 14 days

Intervention Type DRUG

Placebo

Placebo tablet once daily dosing for 14 days

Intervention Type DRUG

PF-06743649

To be decided dose, tablet once daily dosing for 14 days

Intervention Type DRUG

Placebo

Placebo tablet once daily dosing for 14 days

Intervention Type DRUG

PF-06743649

To be decided dose, tablet once daily dosing for 14 days

Intervention Type DRUG

Placebo

Placebo tablet once daily dosing for 14 days

Intervention Type DRUG

PF-06743649

To be decided dose, tablet once daily dosing for 14 days

Intervention Type DRUG

Placebo

Placebo tablet once daily dosing for 14 days

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Healthy male and/or female subjects between the ages of 65 and 85 years, inclusive. Ideally at least 25% of the subjects enrolled in each cohort will be 75 years of age and above at Screening. Subjects must be healthy as determined by the investigator based on a detailed medical history, full physical examination (including blood pressure and pulse rate measurement), 12-lead ECG and clinical laboratory test results. Subjects with mild, chronic, stable disease and on stable medication may be enrolled if deemed medically prudent by the investigator.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

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).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* Evidence of gout/hyperuricemia, measured sUA \>8 mg/dL at screening.
* Experienced an episode of nephrolithiasis or ureterolithiasis.
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 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.

Miami Research Associates, Inc.

South Miami, Florida, United States

Site Status

MRA Clinical Research, LLC

South Miami, Florida, 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=B7911004&StudyName=A%20Study%20In%20Healthy%20Elderly%20People%20To%20Evaluate%20Safety%2C%20Toleration%2C%20Pharmacokinetics%20and%20Pharmacodynamics%20of%20multiple%20Oral%20Doses%20Of%20PF-0

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.

B7911004

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

A Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03049423 In Healthy Adult Volunteers And Healthy Older Volunteers
NCT01161069 COMPLETED PHASE1
Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of PF-06730512
NCT03146065 COMPLETED PHASE1
A Study to Evaluate Safety, Toleration and Time Course of Plasma Concentration of Multiple Oral Doses of PF-06273340 in Healthy Subjects of Two AgeGroups, Aged 18-55 Years (Group 1) and Aged 56-75 Years (Group 2)
NCT01934738 COMPLETED PHASE1
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PF-04958242 in Healthy Adult Volunteers
NCT01238679 TERMINATED PHASE1
Single Dose Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06291874 In Healthy Adult Subjects
NCT01794364 COMPLETED PHASE1
Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of Compound PF-06823859
NCT02766621 COMPLETED PHASE1
Safety and Tolerability Study of Multiple Doses of PF-06305591
NCT01776619 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
Study Of Single And Multiple Ascending Doses Of PF-07054894 In Healthy Adult Participants
NCT04388878 COMPLETED PHASE1
A First-In-Human Study of the Study Medicine, Called PF-07291177, in Healthy Adult Participants
NCT05434091 WITHDRAWN PHASE1
A Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-03882845 In Healthy Volunteers
NCT00971802 COMPLETED PHASE1
A Multiple Dose Study To Determine Safety, Tolerability, and Pharmacokinetics Of PF-04634817 In Healthy Adult Subjects
NCT01140672 COMPLETED PHASE1
Study To Evaluate Safety, Tolerability, And Pharmacokinetics Of PF-06473871 In Normal Healthy Adults
NCT01753791 COMPLETED PHASE1
Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04531083 In Healthy Subjects
NCT01012310 COMPLETED PHASE1
Single Dose Study of PF-06815345 in Healthy Subjects
NCT02654899 TERMINATED PHASE1
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PF-06842874 in Healthy Participants
NCT04124653 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 How Different Amounts of the Study Medicine Called PF-07314470 Are Tolerated and Act in the Body in Healthy Adults
NCT06821750 TERMINATED PHASE1
First-In-Human Study Of Single And Multiple Ascending Doses Of PF-06751979
NCT02509117 COMPLETED PHASE1
A Study To Look At Safety And Blood Concentrations After Multiple Doses Of PF-03382792 In Healthy Elderly Individuals
NCT01089738 WITHDRAWN PHASE1
Safety and Tolerability of PF-06818883 in Healthy Subjects
NCT03020784 TERMINATED PHASE1
A Single Dose Study Of PF-06291874 In Healthy Adult Subjects
NCT01499017 TERMINATED PHASE1
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Repeat Doses of PF-06372865 in Healthy Subjects
NCT03351751 COMPLETED PHASE1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07940369 Are Tolerated and Act in the Body in Healthy Adults.
NCT06532383 COMPLETED PHASE1
Evaluation of Safety, Tolerability and Pharmacokinetics of Single Dose of PF-06480605 in Japanese Healthy Participants
NCT04269538 COMPLETED PHASE1