Cardiovascular DiseasePhase 1NCT00099450
Study of the Tolerability, Pharmacokinetics, and Pharmacodynamics of INS50589 Intravenous Infusion in Healthy Volunteers
A Phase 1 study testing INS50589 Intravenous Infusion in people with Cardiovascular Disease, run by Merck Sharp & Dohme LLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- INS50589 Intravenous Infusion
- Type of treatment
- Injection or infusion
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Mar 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Cardiovascular Disease
- Being tested
- INS50589 Intravenous Infusion
- Keywords
- bleeding, blood transfusion, surgeries
- Medical subject headings
- Cardiovascular Diseases, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INS50589 Intravenous InfusionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet function
Secondary outcomes (1)
Pilot study - not specified
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2004 (estimated)
- Study startDec 2004
- Primary completionMar 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amy Schaberg, BSN, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00099450
- Sponsor's protocol ID
- 025-101
- Status last verified
- Jan 2015
- First submitted
- 14 Dec 2004
- Last updated
- 21 Jan 2015
- Results posted
- No
Publications
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.
PubMed 17654304
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00099450
- Acronym / sponsor ID
- 025-101
- Conditions
- Cardiovascular Disease
- Keywords
- bleeding, blood transfusion, surgeries
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 15 Dec 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INS50589 Intravenous Infusion | Drug | – |
Primary outcome
Platelet function
1 secondary outcome
Pilot study - not specified
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2015.
- Results publication: PubMed 17654304Johnson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Schaberg, BSN study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INS50589 Intravenous Infusion in people with Cardiovascular Disease, run by Merck Sharp & Dohme LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet function. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00099450, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2015.