In This SectionTexas Health Research & Education Institute
Disease or Condition
Heart / Myocardial Infarction
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of 12 Weeks of Dosing With GW856553 and its Effects on Inflammatory Markers, Infarct Size, and Cardiac Function in Subjects With Myocardial Infarction Without STsegment elevation
A Randomized Study to Evaluate the Safety of Dosing With study drug and its Effects in Subjects With Myocardial Infarction
Subjects with a NSTEMI, defined as:
a. symptoms (e.g. chest pain, dyspnea) consistent with acute coronary syndrome, lasting at least 10 minutes, with most recent symptoms occurring within the 24 hours prior to presentation,
b. without persistent ST-segment elevation on admission 12-lead ECG, and
c. with Troponin (T or I) above the upper limit of normal (ULN) for the local institution within 12 hours of presentation.
Subject able to be randomized within 12 hours of presentation.
Subject likely to undergo PCI within 4 to 48 hours post randomization [subjects who do not undergo PCI will not be withdrawn from study].
Male or female subject who is between 54 and 81 years of age.
A female subject is eligible to participate if she is of:
a. Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory), or
b. Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1.1 of the protocol for the duration of dosing and until the first follow-up visit (~2 weeks post last-dose).
Negative urine or serum pregnancy test (in women of child-bearing potential only).
Male subjects must agree to use one of the contraception methods listed in Section 8.1.2 of the protocol. This criterion must be followed from the time of the first dose of study medication until the first follow-up visit (~2 weeks post last-dose). PM111181033
QTcB or QTcF = 530 msec.
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Subject must be able to speak, read, write in English.
History of severe heart failure defined as NYHA class III or IV or those with known severe LV dysfunction [ejection fraction (EF) < 30%] regardless of symptomatic status.
Suspected aortic dissection.
Severe aortic stenosis or other severe valvular disease.
Current known life-threatening condition other than vascular disease (e.g. severe chronic airways disease) that may prevent a subject from completing the study.
Subjects with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with active chronic or acute inflammation (e.g. inflammatory bowel disease, osteomyelitis, pneumonia, etc.).
History of myopathy or rhabdomyolysis.
Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Known to be Hepatitis B or Hepatitis C positive.
Current or anticipated use of steroids (oral or inhaled).
Current or anticipated use of BCRP substrates with a narrow therapeutic index (e.g.
daunorubicin, doxorubicin, topotecan, mitoxantrone).
History of malignancy, other than non-melanoma skin cancer.
Known alcohol or drug abuse within the past 6 months.
Previous exposure to GW856553.
Use of another investigational product within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of IP in the current study.
Any other subject whom the Investigator deems unsuitable for the study (e.g., due to either medical reasons, laboratory abnormalities, expected study medication noncompliance).
Unwillingness or inability to follow the procedures outlined in the protocol used in this study.