Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-28 @ 5:46 AM
Study NCT ID:
NCT00099450
Status:
COMPLETED
Last Update Posted:
2015-01-21
First Post:
2004-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Tolerability, Pharmacokinetics, and Pharmacodynamics of INS50589 Intravenous Infusion in Healthy Volunteers
Sponsor:
Merck Sharp & Dohme LLC
Organization:
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 metabolite(s)
* 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 metabolite(s)
* 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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: