Study of the Tolerability, Pharmacokinetics, and Pharmacodynamics of INS50589 Intravenous Infusion in Healthy Volunteers
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
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2004
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 14, 2004
CompletedFirst Posted
Study publicly available on registry
December 15, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedJanuary 21, 2015
January 1, 2015
3 months
December 14, 2004
January 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Platelet function
Secondary Outcomes (1)
Pilot study - not specified
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Quintiles Phase I Services
Lenexa, Kansas, 66219, United States
Related 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. doi: 10.1080/09537100701268741.
PMID: 17654304RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Amy Schaberg, BSN
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2004
First Posted
December 15, 2004
Study Start
December 1, 2004
Primary Completion
March 1, 2005
Study Completion
March 1, 2005
Last Updated
January 21, 2015
Record last verified: 2015-01