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)

NCT ID: NCT01934738

Last Updated: 2014-03-11

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

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-03-31

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 is to investigate safety, toleration and time course of plasma concentration of multiple oral doses of PF-06273340 for 14 days in healthy subjects of two age groups, aged 18-55 years (Group 1) and aged 56-75 years (Group 2)

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.

Group 1: Cohort 1

Group Type EXPERIMENTAL

PF-06273340

Intervention Type DRUG

Tablets, 100 mg TID, 14 days

Placebo

Intervention Type DRUG

Tablets, TID, 14 days

Group 1: Cohort 2

Group Type EXPERIMENTAL

PF-06273340

Intervention Type DRUG

Tablets, to be decided dose, TID or titration, 14 days

Placebo

Intervention Type DRUG

Tablets, TID or titration, 14 days

Group 1: Cohort 3

Group Type EXPERIMENTAL

PF-06273340

Intervention Type DRUG

Tablets, to be decided dose, TID or titration, 14 days

Placebo

Intervention Type DRUG

Tablets, TID or titration, 14 days

Group 2: Cohort 4

Group Type EXPERIMENTAL

PF-06273340

Intervention Type DRUG

Tablets, to be decided dose, TID or titration, 14 days

Placebo

Intervention Type DRUG

Tablets, TID or titration, 14 days

Group 1: Cohort 5

Group Type EXPERIMENTAL

PF-06273340

Intervention Type DRUG

Tablets, to be decided dose, TID or titration, 14 days

Placebo

Intervention Type DRUG

Tablets, TID or titration, 14 days

Group 2: Cohort 6

Group Type EXPERIMENTAL

PF-06273340

Intervention Type DRUG

Tablets, to be decided dose, TID or titration, 14 days

Placebo

Intervention Type DRUG

Tablets, TID or titration, 14 days

Interventions

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

PF-06273340

Tablets, 100 mg TID, 14 days

Intervention Type DRUG

Placebo

Tablets, TID, 14 days

Intervention Type DRUG

PF-06273340

Tablets, to be decided dose, TID or titration, 14 days

Intervention Type DRUG

Placebo

Tablets, TID or titration, 14 days

Intervention Type DRUG

PF-06273340

Tablets, to be decided dose, TID or titration, 14 days

Intervention Type DRUG

Placebo

Tablets, TID or titration, 14 days

Intervention Type DRUG

PF-06273340

Tablets, to be decided dose, TID or titration, 14 days

Intervention Type DRUG

Placebo

Tablets, TID or titration, 14 days

Intervention Type DRUG

PF-06273340

Tablets, to be decided dose, TID or titration, 14 days

Intervention Type DRUG

Placebo

Tablets, TID or titration, 14 days

Intervention Type DRUG

PF-06273340

Tablets, to be decided dose, TID or titration, 14 days

Intervention Type DRUG

Placebo

Tablets, TID or titration, 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

* For Group 1 specific: Healthy male and/or female subjects of non-childbearing 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 pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* For Group 2 specific: Healthy male and/or female subjects of non-childbearing potential between the ages of 56 and 75 years, inclusive. Subjects must be in reasonably good health 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 tests. Subjects with mild, chronic, stable disease (eg, osteoarthritis) may be enrolled if deemed medically prudent by the investigator. In order to ensure an age range relevant to the osteoarthritis (OA) population, at least 50% of the subjects enrolled in these cohorts must be 60 years of age and above at Screening.
* For Group 2 specific: Subjects taking daily prescription or non-prescription medications for management of acceptable chronic medical conditions must be on a stable dose of these, as defined by non change in dose for the 3 months prior to the first dose of study medication and no planned changes during the conduct 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 the time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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

Brussels, , Belgium

Site Status

Countries

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

Belgium

Related Links

Other Identifiers

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

B5261002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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