Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00099450
Status:
COMPLETED
Last Update Posted:
2015-01-21
First Post:
2004-12-14
Brief Title:
Study of the Tolerability Pharmacokinetics and Pharmacodynamics of INS50589 Intravenous Infusion in Healthy Volunteers
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
Single-Center Open-Labeled Dose Escalation Followed by Randomized Double-Blind Placebo-Controlled Cohort Study of the Tolerability Pharmacokinetics and Pharmacodynamics of INS50589 Intravenous Infusion in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2015-01
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 objectives of this study are to look at the safety and tolerability of the experimental drug how people process the drug how the drug affects people and to identify a dose or doses to study in subsequent future studies
Detailed Description:
The purposes of this trial are to determine if administration of INS50589 Intravenous Infusion is well tolerated to determine the pharmacological effects of INS50589 at different doses and to identify an appropriate dose for later efficacy studies More specifically the objectives are to
Evaluate safety and tolerability
Evaluate pharmacokinetics of INS50589 and its major metabolites
Evaluate effects of INS50589 on platelet function at various dose levels
Evaluate potential relationship between plasma concentrations of INS50589 and various pharmacodynamic endpoints
Identify one or more dose levels of INS50589 for future studies
Evaluate safety and tolerability
Evaluate pharmacokinetics of INS50589 and its major metabolites
Evaluate effects of INS50589 on platelet function at various dose levels
Evaluate potential relationship between plasma concentrations of INS50589 and various pharmacodynamic endpoints
Identify one or more dose levels of INS50589 for future studies
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