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

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 - Aspirin interaction study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34161

Enrollment

Registered

2010-12-30

Start date

2011-02-06

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coagulation platelet aggregation

Interventions

administration of sugammadex (2x active treatment, 2x placebo) and aspirin

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 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

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.

Design outcomes

Primary

Measure	Time frame
collagen-induced whole blood aggregometry	—

Secondary

Measure	Time frame
- APTT, PT, ACT, TGT, factor Xa generation - cutaneous bleeding time	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)