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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00099450
First received: December 14, 2004
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Cardiovascular Disease
Drug: INS50589 Intravenous Infusion
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Platelet function

Secondary Outcome Measures:
  • Pilot study - not specified

Estimated Enrollment: 48
Study Start Date: December 2004
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099450

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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00099450     History of Changes
Other Study ID Numbers: 025-101
Study First Received: December 14, 2004
Last Updated: February 13, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014