Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00102674
Status:
COMPLETED
Last Update Posted:
2011-08-16
First Post:
2005-01-31
Brief Title:
PharmacokineticsPharmacodynamics PKPD of Cangrelor
Sponsor:
The Medicines Company
Organization:
The Medicines Company
Study Overview
Official Title:
The Pharmacokinetics and Pharmacodynamics of a Cangrelor Bolus Plus Infusion in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2005-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purposes of this study are to
Evaluate the tolerability of two cangrelor regimens
Compare the PD of cangrelor regimens with oral clopidogrel
Evaluate the tolerability of two cangrelor regimens
Compare the PD of cangrelor regimens with oral clopidogrel
Detailed Description:
The purposes of this study are
To evaluate the tolerability of two cangrelor regimens of bolus plus infusion A and B
To characterize the pharmacokinetics of Cangrelor A and B
To compare the pharmacodynamics of cangrelor regimens with that of an oral 600 mg dose of clopidogrel A B C and D
To determine the effect of prior cangrelor treatment on the pharmacodynamics of clopidogrel C and D
To determine the effect of prior clopidogrel treatment on the pharmacodynamics of cangrelor Group D
To determine the effects of concomitant clopidogrel and cangrelor exposure on the pharmacodynamics of clopidogrel Group D
To evaluate the tolerability of two cangrelor regimens of bolus plus infusion A and B
To characterize the pharmacokinetics of Cangrelor A and B
To compare the pharmacodynamics of cangrelor regimens with that of an oral 600 mg dose of clopidogrel A B C and D
To determine the effect of prior cangrelor treatment on the pharmacodynamics of clopidogrel C and D
To determine the effect of prior clopidogrel treatment on the pharmacodynamics of cangrelor Group D
To determine the effects of concomitant clopidogrel and cangrelor exposure on the pharmacodynamics of clopidogrel Group D
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None