A Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Volunteers
April 21, 2016 updated by: Pfizer
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- 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
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Brussels, Belgium, B-1070
- Pfizer Clinical Research Unit
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
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
|
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
0.3 micrograms per kilogram of PF-05230907, IV bolus, single dose
0.3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
1 micrograms per kilogram of PF-05230907, IV bolus, single dose
1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
2 micrograms per kilogram of PF-05230907, IV bolus, single dose
2 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
3 micrograms per kilogram of PF-05230907, IV bolus, single dose
3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
5 micrograms per kilogram of PF-05230907, IV bolus, single dose
5 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
|
|
Experimental: PF-05230907 and Placebo Cohort 2
|
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
0.3 micrograms per kilogram of PF-05230907, IV bolus, single dose
0.3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
1 micrograms per kilogram of PF-05230907, IV bolus, single dose
1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
2 micrograms per kilogram of PF-05230907, IV bolus, single dose
2 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
3 micrograms per kilogram of PF-05230907, IV bolus, single dose
3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
5 micrograms per kilogram of PF-05230907, IV bolus, single dose
5 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
|
|
Experimental: PF-05230907 and Placebo Cohort 3
|
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
0.3 micrograms per kilogram of PF-05230907, IV bolus, single dose
0.3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
1 micrograms per kilogram of PF-05230907, IV bolus, single dose
1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
2 micrograms per kilogram of PF-05230907, IV bolus, single dose
2 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
3 micrograms per kilogram of PF-05230907, IV bolus, single dose
3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
5 micrograms per kilogram of PF-05230907, IV bolus, single dose
5 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
|
|
Experimental: PF-05230907 and Placebo Cohort 4
|
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
0.3 micrograms per kilogram of PF-05230907, IV bolus, single dose
0.3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
1 micrograms per kilogram of PF-05230907, IV bolus, single dose
1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
2 micrograms per kilogram of PF-05230907, IV bolus, single dose
2 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
3 micrograms per kilogram of PF-05230907, IV bolus, single dose
3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
5 micrograms per kilogram of PF-05230907, IV bolus, single dose
5 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
|
|
Experimental: PF-05230907 and Placebo Cohort 5
|
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
0.3 micrograms per kilogram of PF-05230907, IV bolus, single dose
0.3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
1 micrograms per kilogram of PF-05230907, IV bolus, single dose
1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
2 micrograms per kilogram of PF-05230907, IV bolus, single dose
2 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
3 micrograms per kilogram of PF-05230907, IV bolus, single dose
3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
5 micrograms per kilogram of PF-05230907, IV bolus, single dose
5 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
|
|
Experimental: PF-05230907 and Placebo Cohort 6
|
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
0.3 micrograms per kilogram of PF-05230907, IV bolus, single dose
0.3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
1 micrograms per kilogram of PF-05230907, IV bolus, single dose
1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
2 micrograms per kilogram of PF-05230907, IV bolus, single dose
2 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
3 micrograms per kilogram of PF-05230907, IV bolus, single dose
3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
5 micrograms per kilogram of PF-05230907, IV bolus, single dose
5 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of dose limiting treatment related adverse events
Time Frame: Through Day 43
|
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
Time Frame: Through Day 43
|
Through Day 43
|
|
Incidence and magnitude of treatment emergent abnormal laboratory findings
Time Frame: Through Day 43
|
Through Day 43
|
|
Change from baseline in vital sign measurements, ECG parameters, and physical examinations
Time Frame: Through Day 43
|
Through Day 43
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time Frame: Through 4 hour post dose Day 1
|
Through 4 hour post dose Day 1
|
|
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Through 4 hour post dose Day 1
|
Through 4 hour post dose Day 1
|
|
Pharmacodynamic activity as measured by prothrombin time/internationalize normalized ration (PT/INR)
Time Frame: Through post dose Day3
|
Through post dose Day3
|
|
Pharmacodynamic activity as measured by activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT)
Time Frame: Through post dose Day3
|
Through post dose Day3
|
|
Pharmacodynamic activity as measured by thrombin-antithrombin (TAT) complexes
Time Frame: Through post dose Day 2
|
Through post dose Day 2
|
|
Pharmacodynamic activity as measured by prothrombin fragments 1+2 (PF1+2)
Time Frame: Through post dose Day 2
|
Through post dose Day 2
|
|
Pharmacodynamic activity as measured by D-dimer
Time Frame: Through post dose Day 7
|
Through post dose Day 7
|
|
Pharmacodynamic activity as measured by protein C activity
Time Frame: Through post dose Day 2
|
Through post dose Day 2
|
|
Pharmacodynamic activity as measured by Factor V activity
Time Frame: Through post dose Day 3
|
Through post dose Day 3
|
|
Incidence of antibody immune response
Time Frame: Through post dose Day 43
|
Through post dose Day 43
|
|
Factor X activity
Time Frame: Through post dose Day 43
|
Through post dose Day 43
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
June 24, 2013
First Submitted That Met QC Criteria
July 8, 2013
First Posted (Estimate)
July 11, 2013
Study Record Updates
Last Update Posted (Estimate)
April 22, 2016
Last Update Submitted That Met QC Criteria
April 21, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- B2341001
- 2013-001387-36 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.