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)

Pfizer

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Placebo

Drug: PF-06273340

Study type

Interventional

Funder types

Industry

Identifiers

NCT01934738

B5261002

Details and patient eligibility

About

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)

Enrollment

52 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

52 participants in 6 patient groups

Group 1: Cohort 1

Experimental group

Treatment:

Drug: Placebo

Drug: PF-06273340

Drug: Placebo

Drug: PF-06273340

Group 1: Cohort 2

Experimental group

Treatment:

Drug: Placebo

Drug: PF-06273340

Drug: Placebo

Drug: PF-06273340

Group 1: Cohort 3

Experimental group

Treatment:

Drug: Placebo

Drug: PF-06273340

Drug: Placebo

Drug: PF-06273340

Group 2: Cohort 4

Experimental group

Treatment:

Drug: Placebo

Drug: PF-06273340

Drug: Placebo

Drug: PF-06273340

Group 1: Cohort 5

Experimental group

Treatment:

Drug: Placebo

Drug: PF-06273340

Drug: Placebo

Drug: PF-06273340

Group 2: Cohort 6

Experimental group

Treatment:

Drug: Placebo

Drug: PF-06273340

Drug: Placebo

Drug: PF-06273340

Trial contacts and locations

1

Loading...