Single Dose Escalation Study of PF-05190457 in Healthy Volunteers

Study Overview
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Brief Summary
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PF-05190457 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The purpose of the study is to evaluate the safety and tolerability of PF-05190457 after administration of a single dose to healthy volunteers and to evaluate the plasma drug concentrations after single dose in healthy volunteers.

Official Title
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A Phase 1 Placebo-controlled Trial to Assess the Safety, Tolerability, and Pharmacokinetics of Single Escalating Oral Doses of PF-05190457 Under Fasted and Fed Conditions in Healthy Adult Subjects

Conditions
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Diabetes Mellitus, Type II

Intervention / Treatment
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* Drug: PF-05190457
* Drug: PF-05190457
* Drug: PF-05190457
* Drug: PF-05190457
* Drug: PF-05190457
* Drug: PF-05190457
* Drug: PF-05190457
* Drug: PF-05190457
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males and females (non-childbearing) between the ages of 18 and 55 with BMI of 17.5 to 30.5 kg/m2; and a total body weight between 50 kg (110 lbs) and 100 kg (220 lb) inclusive Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br> | Drug: PF-05190457<br>* Single Dose 2 mg<br>Drug: PF-05190457<br>* Single Dose 10 mg<br>Drug: PF-05190457<br>* Single Dose 30 mg<br>Drug: PF-05190457<br>* Single Dose 100 mg<br>Drug: PF-05190457<br>* Single Dose 300 mg<br>Drug: PF-05190457<br>* Single Dose 600 mg<br>Drug: PF-05190457<br>* Single Dose - to be determined with food<br>Drug: PF-05190457<br>* Single Dose - to be determined<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Single Dose Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of PF-05190457 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, continuous cardiac monitoring over the first 8 hours after dosing, vital sign and clinical safety laboratory measurements |  | 8 weeks | 
| The single dose PK of PF-05190457 will be described by estimating parameters of AUC(0-infinity), AUC(0-last), AUC(0-24), Cmax, Tmax, CL/F, Vz/F and half-life (t1/2), as the data permit |  | 48 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK of PF-05190457 in the fed condition will be described by estimating parameters of AUC(0-infinity), AUC(0-last), AUC(0-24), Cmax, Tmax, CL/F, Vz/F and half-life (t1/2), |  | 48 hour | 
| Gastric half-emptying time (GET½), the duration of the lag phase (Tlag), gastric emptying coefficient (GEC) |  | Day 1 for Periods 1 and 2, for Cohort 3. |