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)

August 15, 2014 updated by: Pfizer

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-06372865 In Subjects Aged 18-55 (Group 1) And 56-75 Years (Group 2)

The purpose of this study is to investigate safety, toleration and time course of plasma concentration of multiple oral doses of PF-06372865 for 14 days in healthy subjects of two age groups, 18-55 years (Group 1) and 56-75 years (Group 2).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 at Screening. 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.
  • For Group 2 specific: Male and/or female subjects of non-childbearing potential between the ages of 56 and 75 years, inclusive at Screening. 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. 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:

  • For Group 1 specific: 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).
  • For Group 2 specific : Evidence or history of unstable disease or moderate to severe conditions which would, in the Investigator's opinion, interfere with the study evaluations or impact on the safety of participating subjects, such as orthostatic hypotension.
  • Subjects with history of sleep apnea
  • Any condition possibly affecting drug absorption (eg, gastrectomy).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: Cohort 1
Drug: PF-06372865
Tablets, 2.5 mg BID, 14 days
Drug: Placebo
Tablets, BID, 14 days
Drug: PF-06372865
Tablets, to be decided dose, BID or titration, 14 days
Drug: Placebo
Tablets, BID or titration, 14 days
Experimental: Group 1: Cohort 2
Drug: PF-06372865
Tablets, 2.5 mg BID, 14 days
Drug: Placebo
Tablets, BID, 14 days
Drug: PF-06372865
Tablets, to be decided dose, BID or titration, 14 days
Drug: Placebo
Tablets, BID or titration, 14 days
Experimental: Group 1: Cohort 3
Drug: PF-06372865
Tablets, 2.5 mg BID, 14 days
Drug: Placebo
Tablets, BID, 14 days
Drug: PF-06372865
Tablets, to be decided dose, BID or titration, 14 days
Drug: Placebo
Tablets, BID or titration, 14 days
Experimental: Group 2: Cohort 4
Drug: PF-06372865
Tablets, 2.5 mg BID, 14 days
Drug: Placebo
Tablets, BID, 14 days
Drug: PF-06372865
Tablets, to be decided dose, BID or titration, 14 days
Drug: Placebo
Tablets, BID or titration, 14 days
Experimental: Group 1 or 2: Cohort 5
Drug: PF-06372865
Tablets, 2.5 mg BID, 14 days
Drug: Placebo
Tablets, BID, 14 days
Drug: PF-06372865
Tablets, to be decided dose, BID or titration, 14 days
Drug: Placebo
Tablets, BID or titration, 14 days
Experimental: Group 1 or 2: Cohort 6
Drug: PF-06372865
Tablets, 2.5 mg BID, 14 days
Drug: PF-06372865
Tablets, to be decided dose, BID or titration, 14 days

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

February 20, 2014

First Submitted That Met QC Criteria

February 20, 2014

First Posted (Estimate)

February 25, 2014

Study Record Updates

Last Update Posted (Estimate)

August 18, 2014

Last Update Submitted That Met QC Criteria

August 15, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B7431002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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