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

Cardiovascular Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00099450
• Other study ID #: 025-101
• Status: Completed
• Phase: Phase 1
• First received: December 14, 2004
• Last updated: January 19, 2015
• Start date: December 2004
• Est. completion date: March 2005

Study information

• Verified date: January 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• INS50589 Intravenous Infusion

Locations

Country	Name	City	State
United States	Quintiles Phase I Services	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Johnson FL, Boyer JL, Leese PT, Crean C, Krishnamoorthy R, Durham T, Fox AW, Kellerman DJ. Rapid and reversible modulation of platelet function in man by a novel P2Y(12) ADP-receptor antagonist, INS50589. Platelets. 2007 Aug;18(5):346-56. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet function
Secondary	Pilot study - not specified