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)

Study Overview
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Brief Summary
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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).

Official Title
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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)

Conditions
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Healthy

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple dose, safety, tolerability, PK