Safety and Tolerability Study of Multiple Doses of PF-06305591

Study Overview
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Brief Summary
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Safety, tolerability and PK of repeated doses of PF-06305591 will be evaluated in young healthy volunteers toghether with food effect on relative bioavailability of solid formulation after single dose.

Official Title
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A Double Blind (3rd Party Open) Randomized, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics of Repeat Doses PF-06305591 Combined With a Cross-over Relative Bioavailability and Food Effect Evaluation After Single Dose of PF-06305591 in Healthy Young Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-06305591
* Drug: Placebo
* Drug: PF-06305591
* Drug: Placebo
* Drug: PF-06305591
* Drug: Placebo
* Drug: PF-06305591
* Drug: PF-06305591


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female subjects of non childbearing potential, between the ages of 21 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 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).

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 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: Multiple Dose: Cohort 1<br> | Drug: PF-06305591<br>* 14 day repeated 20mg BID doses<br>Drug: Placebo<br>* 14 day repeated BID doses<br>|
| Experimental: Multiple Dose: Cohort 2<br> | Drug: PF-06305591<br>* 14 day repeated 80mg BID doses<br>Drug: Placebo<br>* 14 day repeated BID doses<br>|
| Experimental: Multiple Dose: Cohort 3<br> | Drug: PF-06305591<br>* 14 day repeated 40mg BID doses<br>Drug: Placebo<br>* 14 day repeated BID doses<br>|
| Experimental: Multiple Dose: Cohort 4<br> | Drug: PF-06305591<br>* 14 day repeated BID doses<br>|
| Experimental: Relative Bioavilability: Cohort 1<br> | Drug: PF-06305591<br>* relative bioavailability tablet vs. solution and food effect at 50mg dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. | 14 days | 
| Maximum Observed Plasma Concentration (Cmax) |  | 14 days | 
| Area under the Concentration-Time Curve (AUC) | AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. | 14 days | 
| Area Under the Curve from Time Zero to end of dosing interval (AUCtau) | AUC is a measure of the serum concentration of the drug over time interval. It is used to characterize drug absorption. | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, tolerability, PK