A randomized, double-blind, placebo-controlled, 4-period cross-over drug-drug interaction study to evaluate the effect of sugammadex and aspirin on platelet aggregation and coagulation parameters in young healthy male volunteers

Completed

• Conditions: coagulation; platelet aggregation; 10035534; 10014523

• Registration Number: NL-OMON34161
• Lead Sponsor: Schering-Plough

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

- Healthy male volunteers
- 18-45 years of age
- BMI 18-32
- Subjects must be free of any clinically significant disease that would interfere with the study evaluations.
- No clinically significant abnormalities in laboratory tests (chemistry, hematology, virology, coagulation, platelet count )
- Normal physical examination (including vital sign measurements), normal ECG
- Subject agrees to use one of the accepted methods of contraception

Exclusion Criteria

- Clinically significant abnormalities in laboratory tests (chemistry, hematology, virology, coagulation) or physical examination
- Subject*s female partner is pregnant, intends to become pregnant (within 3 months of ending the study), or is breastfeeding.
- Drug or alcohol abuse
- smoking more than 10 cigarettes per day.
- Subject is not able to refrain from alcohol, grapefruit, xanthines as descibed in the protocol
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug.
- history of an unexplained reaction or hypersensitivity reaction during previous surgery and/or anesthesia.
- history of anaphylaxis from any cause, a suspected history of hypersensitivity reactions to cyclodextrins, or multiple drug hypersensitivities.
- 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 trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>collagen-induced whole blood aggregometry </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- APTT, PT, ACT, TGT, factor Xa generation<br /><br>- cutaneous bleeding time</p><br>