Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of PER977 Following Heparin
Information source: Perosphere, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: PER977 (Drug); Placebo (Drug)
Phase: Phase 1/Phase 2
Status: Active, not recruiting
Sponsored by: Perosphere, Inc. Official(s) and/or principal investigator(s): Barbara Lomeli, MD, Principal Investigator, Affiliation: Quintiles
Summary
Normal subjects will receive unfractionated heparin followed by a single dose of PER977 with
dose escalation by cohort. Ten subjects enrolled in Cohort 4 will receive a single dose of
PER977 followed by a one-week washout and then will receive unfractionated heparin followed
by a single dose of PER977. The study will provide some insight into the doses that may be
required to reverse anticoagulation induced by heparin. PER977 administration following
heparin sodium injection will have an acceptable safety and tolerability profile with no
impact on pro-coagulant biomarkers.
Clinical Details
Official title: Phase I/II Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of a Single Escalating Dose of PER977 Following Administration of Unfractionated Heparin
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)
Primary outcome: Effect of PER977 on reversal of heparin anticoagulation
Secondary outcome: Safety and tolerability of PER977 administered following heparin
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Adults age 18 to 65 years, inclusive
2. Laboratory values have no clinically significant abnormalities as judged by the
Investigator.
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 (serum creatinine) 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 unfractionated heparin, thrombocytopenia with a positive in vitro
test to anti-platelet antibody in the presence of unfractionated heparin,
hypersensitivity to heparin or porcine products or any other contraindication to
unfractionated heparin
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
Locations and Contacts
Quintiles, Overland Park, Kansas 66211, United States
Additional Information
Starting date: June 2014
Last updated: May 19, 2015
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