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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00099450
Recruitment Status : Completed
First Posted : December 15, 2004
Last Update Posted : January 21, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Drug: INS50589 Intravenous Infusion Phase 1

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  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : December 2004
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Primary Outcome Measures :
  1. Platelet function

Secondary Outcome Measures :
  1. Pilot study - not specified

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00099450

United States, Kansas
Quintiles Phase I Services
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Amy Schaberg, BSN

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00099450     History of Changes
Other Study ID Numbers: 025-101
First Posted: December 15, 2004    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015

Keywords provided by Merck Sharp & Dohme Corp.:
blood transfusion

Additional relevant MeSH terms:
Cardiovascular Diseases
INS 50589
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs