A Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Volunteers
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
2 other identifiers
interventional
49
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Sep 2013
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2013
CompletedFirst Posted
Study publicly available on registry
July 11, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedApril 22, 2016
April 1, 2016
1.5 years
June 24, 2013
April 21, 2016
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (11)
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
- +6 more secondary outcomes
Study Arms (6)
PF-05230907 and Placebo Cohort 1
EXPERIMENTALPF-05230907 and Placebo Cohort 2
EXPERIMENTALPF-05230907 and Placebo Cohort 3
EXPERIMENTALPF-05230907 and Placebo Cohort 4
EXPERIMENTALPF-05230907 and Placebo Cohort 5
EXPERIMENTALPF-05230907 and Placebo Cohort 6
EXPERIMENTALInterventions
0.1 micrograms per kilogram of PF-05230907, IV bolus, single dose
0.1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
Eligibility Criteria
You may qualify if:
- Healthy male subjects.
- Healthy non-child bearing female subjects.
- to 35 years of age.
You may not qualify if:
- Heart disease.
- Clotting disorders.
- Use of nicotine products.
- Diabetes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Clinical Research Unit
Brussels, B-1070, Belgium
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2013
First Posted
July 11, 2013
Study Start
September 1, 2013
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
April 22, 2016
Record last verified: 2016-04