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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: PF-05230907; Drug: Placebo for PF-05230907

• Registration Number: NCT01897142
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-24
• Study First Submitted QC: 2013-07-08
• Study First Posted: 2013-07-11
• Study Start: 2013-09
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-21
• Last Update Posted: 2016-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PF-05230907 and Placebo Cohort 1	PF-05230907	-
PF-05230907 and Placebo Cohort 1	Placebo for PF-05230907	-
PF-05230907 and Placebo Cohort 2	PF-05230907	-
PF-05230907 and Placebo Cohort 2	Placebo for PF-05230907	-
PF-05230907 and Placebo Cohort 3	PF-05230907	-
PF-05230907 and Placebo Cohort 3	Placebo for PF-05230907	-
PF-05230907 and Placebo Cohort 4	PF-05230907	-
PF-05230907 and Placebo Cohort 5	PF-05230907	-
PF-05230907 and Placebo Cohort 5	Placebo for PF-05230907	-
PF-05230907 and Placebo Cohort 6	PF-05230907	-
PF-05230907 and Placebo Cohort 6	Placebo for PF-05230907	-
PF-05230907 and Placebo Cohort 4	Placebo for PF-05230907	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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 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

Trial Locations

Locations (1)

Pfizer Clinical Research Unit; 🇧🇪 Brussels, Belgium