coagulation thrombus
Conditions
Interventions
part 1 - intereractiion sugammadex and enoxaparine: administration of
sugammadex (2x 4 mg/kg, 1x 16 mg/kg, 1x placebo) and enoxaparin (3x 40 mg, 1x
placebo)
part 2 - interaction sugammadex and UFH:
Sponsors
Schering-Plough
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Healthy male volunteers - 18-45 years of age - BMI 18-32 - Subjects must be free of any clinical significant disease that would interfere with the study evaluations. - No clinically significant abnormalities in laboratory tests (chemistry, hematology, virology, urinalysis) - APTT and PT within normal limits and anti-Xa activity below LLOQ - Normal physical examination (including vital sign measurements), normal ECG
Exclusion criteria
Exclusion criteria: - Subject's female partner is pregnant, intends to become pregnant (within 3 months of ending the study), or is breastfeeding - Subject who will not be able to participate optimally in the study - Contraindications to heparin or enoxaparin or history of heparin induced thrombocytopenia - A (suspected) history of hypersensitivity or hypersensitivity-like reaction to sugammadex, history of sensitivity/idiosyncrasy to chemically related compounds or excipients which could be employed in the study or to any other unknown drug used in the past - Subject is not able to refrain from alcohol, grapefruit, xanthines as described in protocol - Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug - History of infectious disease during past month that in the opinion of the investigator, affects subject's ability to participate in the study - History of an unexplained reaction or hypersensitivity reaction during previous surgery and/or anesthesia - Subject who underwent surgery during past year - History of anaphylaxis from any cause, a suspected history of hypersensitivity reactions to cyclodextrins, or multiple drug hypersensitivities - History of allergic reactions (eg, food, drug, atopic reactions or asthmatic episodes) which, in the opinion of the investigator, interfere with their ability to participate in the study - Positive screen for drugs or alcohol - Drug or alcohol abuse in the past 2 years - Smoking more than 10 cigarettes or equivalent tobacco use per day - Clinically significant abnormalities in laboratory tests (chemistry, hematology, virology, coagulation) or physical examination - Subjects with hereditary vitamin K dependent clotting factor deficiencies and/or pre-existing coagulopathies - History of gastrointestinal bleeding, easy bruising, frequent nose bleeds - Previous exposure to sugammadex
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| part 1 - to investigate the potential effect of 4 mg/kg and 16 mg/kg sugammadex on the Anti-Xa anticoagulant activity of enoxaparin. part 2 - to investigate the potential effect of 4 mg/kg and 16 mg/kg sugammadex on the APTT anticoagulant activity of UFH. | — |
Secondary
| Measure | Time frame |
|---|---|
| part 1: - To investigate the potential effect of 4 mg/kg and 16 mg/kg sugammadex on the APTT anticoagulant activity of enoxaparin. - To evaluate the effect of enoxaparin on the potential APTT anticoagulant activity of 4 mg/kg sugammadex. - To evaluate the potential anticoagulant activity of 4 mg/kg sugammadex as compared to baseline. Anti-Xa activity and APTT will be the secondary endpoint measures. - To evaluate the safety and tolerability of sugammadex alone or in combination with enoxaparin. part 2 - To evaluate the effect of UFH on the potential APTT anticoagulant activity of 16 mg/kg sugammadex. - To evaluate the potential anticoagulant activity of 16 mg/kg sugammadex as compared to baseline; APTT and anti-Xa activity will be the secondary endpoint measures. - To evaluate the safety and tolerability of sugammadex alone or in combination with UFH. | — |
Countries
Netherlands
Outcome results
None listed