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)

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT02070289

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: PF-06372865 Drug: Placebo Drug: PF-06372865 Drug: Placebo Drug: PF-06372865 Drug: Placebo Drug: PF-06372865 Drug: Placebo Drug: PF-06372865 Drug: Placebo Drug: PF-06372865	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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)

Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Brussels		Belgium	B-1070

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT02070289

Other Study ID Numbers:

B7431002

First Posted:

Feb 25, 2014

Last Update Posted:

Aug 18, 2014

Last Verified:

Aug 1, 2014

Keywords provided by Pfizer

Multiple dose

safety

tolerability

Additional relevant MeSH terms:

PF-06372865

Study Results

No Results Posted as of Aug 18, 2014