Recruitment

Recruitment Status
Completed

Inclusion Criteria

Signed and dated, written informed consent (Institutional Review Board [IRB]-approved informed consent form [ICF]).
Healthy male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture. (Healthy as determined by medical history)
Signed and dated, written informed consent (Institutional Review Board [IRB]-approved informed consent form [ICF]).
Healthy male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture. (Healthy as determined by medical history)

Exclusion Criteria

Significant infection or known inflammatory process within 2 weeks of screening.
Received non-steroidal anti-inflammatory (NSAID) or medications (including any type of anticoagulant or aspirin [ASA]) with a direct effect on hemostasis within 7 days of testing
Treatment with any investigational products or therapies within 30 days (or 5 half lives, whichever is greater) prior to screening.
...
Significant infection or known inflammatory process within 2 weeks of screening.
Received non-steroidal anti-inflammatory (NSAID) or medications (including any type of anticoagulant or aspirin [ASA]) with a direct effect on hemostasis within 7 days of testing
Treatment with any investigational products or therapies within 30 days (or 5 half lives, whichever is greater) prior to screening.
Healthy subjects who do not conform to the above inclusion criteria.
Healthy volunteer with a propensity to bleed (i.e. due to recent trauma, recent surgery, peptic ulcer, active or recent gastrointestinal bleeding or bleeding from hemorrhoids).
Unwillingness or inability to comply with procedures required in this protocol.
Subjects who are concurrently enrolled in any other clinical study.
History of major bleeding or major trauma within the past 6 months
Healthy subjects who cannot communicate reliably with the Investigator.

Summary

Conditions
Healthy
Type
Interventional
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Other

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Description

No investigational product was administered to any subject in this study.

No investigational product was administered to any subject in this study.

Inclusion Criteria

Signed and dated, written informed consent (Institutional Review Board [IRB]-approved informed consent form [ICF]).
Healthy male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture. (Healthy as determined by medical history)
Signed and dated, written informed consent (Institutional Review Board [IRB]-approved informed consent form [ICF]).
Healthy male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture. (Healthy as determined by medical history)

Exclusion Criteria

Significant infection or known inflammatory process within 2 weeks of screening.
Received non-steroidal anti-inflammatory (NSAID) or medications (including any type of anticoagulant or aspirin [ASA]) with a direct effect on hemostasis within 7 days of testing
Treatment with any investigational products or therapies within 30 days (or 5 half lives, whichever is greater) prior to screening.
...
Significant infection or known inflammatory process within 2 weeks of screening.
Received non-steroidal anti-inflammatory (NSAID) or medications (including any type of anticoagulant or aspirin [ASA]) with a direct effect on hemostasis within 7 days of testing
Treatment with any investigational products or therapies within 30 days (or 5 half lives, whichever is greater) prior to screening.
Healthy subjects who do not conform to the above inclusion criteria.
Healthy volunteer with a propensity to bleed (i.e. due to recent trauma, recent surgery, peptic ulcer, active or recent gastrointestinal bleeding or bleeding from hemorrhoids).
Unwillingness or inability to comply with procedures required in this protocol.
Subjects who are concurrently enrolled in any other clinical study.
History of major bleeding or major trauma within the past 6 months
Healthy subjects who cannot communicate reliably with the Investigator.

Tracking Information

NCT #
NCT02205827
Collaborators
Quintiles, Inc.
Investigators
Study Director: James Costin, MD Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
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