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)

A Phase 1, Double Blind (3rd Party Open) Randomized, Placebo Controlled, Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of Repeat Doses of PF-06273340 in Healthy Subjects

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)

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PF-06273340; Drug: Placebo; Drug: PF-06273340; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, B-1070
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Cohort 1	Drug: PF-06273340; Tablets, 100 mg TID, 14 days; Drug: Placebo; Tablets, TID, 14 days; Drug: PF-06273340; Tablets, to be decided dose, TID or titration, 14 days; Drug: Placebo; Tablets, TID or titration, 14 days
Experimental: Group 1: Cohort 2	Drug: PF-06273340; Tablets, 100 mg TID, 14 days; Drug: Placebo; Tablets, TID, 14 days; Drug: PF-06273340; Tablets, to be decided dose, TID or titration, 14 days; Drug: Placebo; Tablets, TID or titration, 14 days
Experimental: Group 1: Cohort 3	Drug: PF-06273340; Tablets, 100 mg TID, 14 days; Drug: Placebo; Tablets, TID, 14 days; Drug: PF-06273340; Tablets, to be decided dose, TID or titration, 14 days; Drug: Placebo; Tablets, TID or titration, 14 days
Experimental: Group 2: Cohort 4	Drug: PF-06273340; Tablets, 100 mg TID, 14 days; Drug: Placebo; Tablets, TID, 14 days; Drug: PF-06273340; Tablets, to be decided dose, TID or titration, 14 days; Drug: Placebo; Tablets, TID or titration, 14 days
Experimental: Group 1: Cohort 5	Drug: PF-06273340; Tablets, 100 mg TID, 14 days; Drug: Placebo; Tablets, TID, 14 days; Drug: PF-06273340; Tablets, to be decided dose, TID or titration, 14 days; Drug: Placebo; Tablets, TID or titration, 14 days
Experimental: Group 2: Cohort 6	Drug: PF-06273340; Tablets, 100 mg TID, 14 days; Drug: Placebo; Tablets, TID, 14 days; Drug: PF-06273340; Tablets, to be decided dose, TID or titration, 14 days; Drug: Placebo; Tablets, TID or titration, 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum Observed Plasma Concentration (Cmax)	14 days
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)	14 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)	14 days

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: August 30, 2013
• First Submitted That Met QC Criteria: August 30, 2013
• First Posted (Estimate): September 4, 2013

Study Record Updates

• Last Update Posted (Estimate): March 11, 2014
• Last Update Submitted That Met QC Criteria: March 9, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: tolerability; safety; PK; Multiple dose
• Other Study ID Numbers: B5261002