A randomized, double-blind, placebo-controlled, 4-period, two part cross-over study to evaluate the potential interaction effect between 4 mg/kg and 16 mg/kg sugammadex and enoxaparin or unfractionated heparin on anticoagulation activity in young healthy male volunteers
- Conditions
- coagulationthrombus10014523
- Registration Number
- NL-OMON36201
- Lead Sponsor
- Schering-Plough
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>part 1 - to investigate the potential effect of 4 mg/kg and 16 mg/kg sugammadex<br /><br>on the Anti-Xa anticoagulant activity of enoxaparin.<br /><br><br /><br>part 2 - to investigate the potential effect of 4 mg/kg and 16 mg/kg sugammadex<br /><br>on the APTT anticoagulant activity of UFH.</p><br>
- Secondary Outcome Measures
Name Time Method