Study of the Tolerability, Pharmacokinetics, and Pharmacodynamics of INS50589 Intravenous Infusion in Healthy Volunteers

January 19, 2015 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Quintiles Phase I Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have body mass index (BMI) between 18.5 kg/m2 and 35 kg/m2 and body weight no greater than 120 kg.
  • If female, must not be pregnant or lactating, and if of childbearing potential or sexually active, must use acceptable method of birth control.

Exclusion Criteria:

  • Have clinically significant acute or chronic disease (e.g., coronary artery disease, diabetes, chronic renal insufficiency, asthma).
  • Have major surgery within eight weeks of dosing.
  • Have overt viral illness within four weeks of dosing.
  • Have tendency or history in family of tendency for bleeding.
  • Have clinically significant abnormalities on clinical laboratory tests (chemistry, hematology, urinalysis).
  • Have taken aspirin or any other non-steroidal anti-inflammatory drug (NSAID) within 10 days prior to admission to study facility.
  • Have ever taken or received any of the following for medical conditions: (antiplatelet compounds including clopidogrel, ticlopidine, dipyridamole, tirofiban, eptifibatide, abciximab, adenosine, and prostacyclin) or (anticoagulants including vitamin K antagonists, thrombin inhibitors, heparins, hirudin or related compounds, argatroban and factor Xa inhibitors)
  • Have a clinically significant ECG abnormality.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Platelet function

Secondary Outcome Measures

Outcome Measure
Pilot study - not specified

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (ACTUAL)

March 1, 2005

Study Completion (ACTUAL)

March 1, 2005

Study Registration Dates

First Submitted

December 14, 2004

First Submitted That Met QC Criteria

December 14, 2004

First Posted (ESTIMATE)

December 15, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

January 21, 2015

Last Update Submitted That Met QC Criteria

January 19, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 025-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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