A Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to determine what the study drug does to the body, what the body does to the study drug, and if the study drug is safe and well tolerated when given to adult healthy volunteers.

Official Title
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A Phase 1, Randomized, Double-blind, Sponsor-open, Placebo-controlled, Single Ascending Dose Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Biological: PF-05230907
* Drug: Placebo for PF-05230907
* Biological: PF-05230907
* Drug: Placebo for PF-05230907
* Biological: PF-05230907
* Drug: Placebo for PF-05230907
* Biological: PF-05230907
* Drug: Placebo for PF-05230907
* Biological: PF-05230907
* Drug: Placebo for PF-05230907
* Biological: PF-05230907
* Drug: Placebo for PF-05230907


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects. Healthy non-child bearing female subjects. 18 to 35 years of age. Exclusion Criteria: Heart disease. Clotting disorders. Use of nicotine products. Diabetes.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-05230907 and Placebo Cohort 1<br> | Biological: PF-05230907<br>* 0.1 micrograms per kilogram of PF-05230907, IV bolus, single dose<br>Drug: Placebo for PF-05230907<br>* 0.1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose<br>|
| Experimental: PF-05230907 and Placebo Cohort 2<br> | Biological: PF-05230907<br>* 0.3 micrograms per kilogram of PF-05230907, IV bolus, single dose<br>Drug: Placebo for PF-05230907<br>* 0.3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose<br>|
| Experimental: PF-05230907 and Placebo Cohort 3<br> | Biological: PF-05230907<br>* 1 micrograms per kilogram of PF-05230907, IV bolus, single dose<br>Drug: Placebo for PF-05230907<br>* 1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose<br>|
| Experimental: PF-05230907 and Placebo Cohort 4<br> | Biological: PF-05230907<br>* 2 micrograms per kilogram of PF-05230907, IV bolus, single dose<br>Drug: Placebo for PF-05230907<br>* 2 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose<br>|
| Experimental: PF-05230907 and Placebo Cohort 5<br> | Biological: PF-05230907<br>* 3 micrograms per kilogram of PF-05230907, IV bolus, single dose<br>Drug: Placebo for PF-05230907<br>* 3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose<br>|
| Experimental: PF-05230907 and Placebo Cohort 6<br> | Biological: PF-05230907<br>* 5 micrograms per kilogram of PF-05230907, IV bolus, single dose<br>Drug: Placebo for PF-05230907<br>* 5 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dose limiting treatment related adverse events |  | Through Day 43 | 
| Incidence, severity and causal relationship of treatment emergent adverse events, treatment emergent serious adverse events, and withdrawals due to treatment emergent adverse events |  | Through Day 43 | 
| Incidence and magnitude of treatment emergent abnormal laboratory findings |  | Through Day 43 | 
| Change from baseline in vital sign measurements, ECG parameters, and physical examinations |  | Through Day 43 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |  | Through 4 hour post dose Day 1 | 
| Maximum Observed Plasma Concentration (Cmax) |  | Through 4 hour post dose Day 1 | 
| Pharmacodynamic activity as measured by prothrombin time/internationalize normalized ration (PT/INR) |  | Through post dose Day3 | 
| Pharmacodynamic activity as measured by activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) |  | Through post dose Day3 | 
| Pharmacodynamic activity as measured by thrombin-antithrombin (TAT) complexes |  | Through post dose Day 2 | 
| Pharmacodynamic activity as measured by prothrombin fragments 1+2 (PF1+2) |  | Through post dose Day 2 | 
| Pharmacodynamic activity as measured by D-dimer |  | Through post dose Day 7 | 
| Pharmacodynamic activity as measured by protein C activity |  | Through post dose Day 2 | 
| Pharmacodynamic activity as measured by Factor V activity |  | Through post dose Day 3 | 
| Incidence of antibody immune response |  | Through post dose Day 43 | 
| Factor X activity |  | Through post dose Day 43 |