CompletedPhase 1/2

PK and PD of Single, Escalating Doses of PER977 Following Enoxaparin

United States40 participantsStarted 2014-04

Plain-language summary

PER977 administration following a single dose of enoxaparin

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Adults age 18 to 65 years, inclusive
✓. Laboratory values have no clinically significant abnormalities
✓. No clinically significant findings on 12-lead electrocardiogram
✓. Body mass index (BMI) 18 to ≤ 27 kg/m2, inclusive
✓. Male subjects agree to use appropriate contraception
✓. 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.
✓. 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.

✕. 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).
✕. History of unexplained syncope
✕. 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
✕. 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 or bleeding from hemorrhoids within six months prior to screening
✕. History of minor bleeding episodes such as epistaxis, 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 personal history of heparin-induced thrombocytopenia
✕. Females with a history of dysfunctional uterine bleeding who have not undergone hysterectomy, including history of menorrhagia, metrorrhagia or polymenorrhea

Number of adverse events

Timeframe: 1 day

NCT IDNCT02206100

SponsorPerosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-08

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Adults age 18 to 65 years, inclusive
✓. Laboratory values have no clinically significant abnormalities
✓. No clinically significant findings on 12-lead electrocardiogram
✓. Body mass index (BMI) 18 to ≤ 27 kg/m2, inclusive
✓. Male subjects agree to use appropriate contraception
✓. 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.
✓. 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.

✕. 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).
✕. History of unexplained syncope
✕. 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
✕. 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 or bleeding from hemorrhoids within six months prior to screening
✕. History of minor bleeding episodes such as epistaxis, 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 personal history of heparin-induced thrombocytopenia
✕. Females with a history of dysfunctional uterine bleeding who have not undergone hysterectomy, including history of menorrhagia, metrorrhagia or polymenorrhea