Clinical trial NCT02206100 (phase 1/phase 2, status: completed)
Conditions: healthy
ICD codes: Z76.3, Z76.2
Drugs: per977, placebo, enoxaparin
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]
Eligibility criteria:

        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