Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
NCT ID:
NCT00099450
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
Study:
NCT00099450
Study Brief:
Protocol Section:
NCT00099450