PK and PD of Single, Escalating Doses of PER977 Following Enoxaparin
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 11/19/2017 |
Start Date: | April 2014 |
End Date: | August 2014 |
Phase I/II Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Single, Hourly-Repeating, Escalating Doses of PER977 Following a Single Subcutaneous Dose of Enoxaparin
PER977 administration following a single dose of enoxaparin
Single escalating doses of PER977 from 100 to 300 mg, of 25 mg PER977 x 4 doses will be
administered following administration of enoxaparin. Serial pharmacokinetic and
pharmacodynamic assessments ( whole blood clotting time) will be performed. Adverse events
will be monitored.
administered following administration of enoxaparin. Serial pharmacokinetic and
pharmacodynamic assessments ( whole blood clotting time) will be performed. Adverse events
will be monitored.
Inclusion Criteria
1. Adults age 18 to 65 years, inclusive
2. Laboratory values have no clinically significant abnormalities
3. No clinically significant findings on 12-lead electrocardiogram
4. Body mass index (BMI) 18 to ≤ 27 kg/m2, inclusive
5. Male subjects agree to use appropriate contraception
6. Female subjects may be surgically sterile or 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 cycles or 28 days following discharge from the
study.
7. Subjects must understand and agree to comply with the requirements of the study and
they must be willing to sign the informed consent form indicating voluntary consent to
participate in the study prior to initiation of screening or study related activities.
Exclusion Criteria:
1. History or current evidence of clinically significant disease. Current evidence of
liver function tests or renal function tests greater than the upper limit of normal.
The presence of Gilbert's Syndrome is acceptable. Current evidence of QTcF > normal
(450±10 msec for males or 470±10 msec for females).
2. History of unexplained syncope
3. Hypersensitivity to enoxaparin sodium, thrombocytopenia with a positive in vitro test
to anti-platelet antibody in the presence of enoxaparin sodium, hypersensitivity to
heparin or porcine products or any other contraindication to enoxaparin
4. History of major bleeding, trauma, surgical procedure of any type, or vaginal delivery
within six months prior to screening
5. History of peptic ulcer, gastrointestinal bleeding or bleeding from hemorrhoids within
six months prior to screening
6. History of minor bleeding episodes such as epistaxis, or gingival bleeding within 1
month prior to screening
7. 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 personal
history of heparin-induced thrombocytopenia
8. Females with a history of dysfunctional uterine bleeding who have not undergone
hysterectomy, including history of menorrhagia, metrorrhagia or polymenorrhea
9. Pregnant or breast-feeding
10. Males with a history of hormone therapy within 3 months prior to screening
11. 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 dosing.
12. Taking any type of medication for more than 14 consecutive days within the 4 weeks
prior to study entry
13. Positive serologic test for HIV, hepatitis C antibody, or hepatitis B surface antigen
14. Donation of blood or blood products within 56 days prior to screening
15. History of randomization in any prior study of PER977
16. Randomization in any study with an investigational compound or device within 30 days
prior to signing informed consent
17. 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
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