Status:
COMPLETED
Study of PER977 Administered to Subjects With Steady State Edoxaban Dosing and Re-anticoagulation With Edoxaban
Lead Sponsor:
Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
Collaborating Sponsors:
Quintiles, Inc.
Conditions:
Anticoagulation Reversal
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study will evaluate the establishment of anticoagulation ("re-anticoagulation") of subjects with edoxaban following reversal by PER977 and will identify a dose regimen of PER977 that reverses the...
Detailed Description
This is a randomized, single-blind, sequential group, ascending PER977 reversal dose study in healthy volunteers. Subjects will be randomized in a 4:1 ratio to receive either PER977 or placebo. All su...
Eligibility Criteria
Inclusion
- Adults age 18 to 65 years, inclusive
- Laboratory values are not clinically significant
- No clinically significant findings on 12-lead electrocardiogram
- Body mass index (BMI) 18 to ≤ 32 kg/m2, inclusive
- Male subjects agree to use appropriate contraception .
- Female subjects may be post-menopausal or, if of child-bearing potential, must have a negative serum pregnancy test prior to enrollment, and must agree to use two forms of acceptable contraception for the duration of the study and for a minimum of one complete menstrual cycle or 28 days following discharge from the study.
- Subjects must sign informed consent
Exclusion
- History or current evidence of clinically significant disease, liver function tests greater than the upper limit of normal (presence of Gilbert's syndrome is acceptable), QTcF \> normal (440±10 msec for males or 460±10 msec for females).
- History of unexplained syncope
- History of major bleeding, trauma, surgical procedure of any type, or vaginal delivery within six months prior to screening
- History of peptic ulcer, gastrointestinal bleeding, including the mouth, within six months prior to screening
- History of minor bleeding episodes such as epistaxis, rectal or hemorrhoidal bleeding or gingival bleeding within 1 month prior to screening
- Personal or family history of clotting disorder or abnormality, excessive bleeding, thrombovascular disease or any hematologic disorder involving platelets or clotting abnormalities or any condition requiring treatment with transfusions, or history of heparin-induced thrombocytopenia
- Females with a history of dysfunctional uterine bleeding, menorrhagia , metrorrhagia or polymenorrhea
- Pregnant or breast-feeding
- Males with a history of hormone therapy within 3 months prior to screening
- Administration of any blood product or anticoagulant within 3 months prior to study entry or any non steroidal anti-inflammatory drug or cyclooxygenase inhibitor within 2 weeks prior to screening
- Taking any type of chronic medication within the 4 weeks prior to study entry (use of hormonal contraceptives is acceptable)
- Positive serologic test for HIV, HCV-Ab, or HBsAG
- Donation of blood or blood products within 56 days prior to screening
- Smokers or use of tobacco and/or nicotine containing products within 3 months prior to dosing as determined by the subject's verbal history
- Participation in any study with an investigational compound or device within 30 days prior to signing informed consent
- History of participation in any prior study of PER977 or edoxaban
- Active drug or alcohol dependence within the prior 12 months or any condition that, in the opinion of the Investigator, would interfere with adherence to study protocol
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT02207257
Start Date
March 1 2014
End Date
November 1 2015
Last Update
May 21 2020
Active Locations (1)
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1
Quintiles
Overland Park, Kansas, United States, 66212