- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01860105
Appraisal of MDCO-157 and Plavix® Pharmacokinetics and Pharmacodynamics in Healthy Volunteers With an Evaluation (AMPHORE)
February 19, 2018 updated by: The Medicines Company
Appraisal of MDCO-157 and Plavix® Pharmacokinetics and Pharmacodynamics in Healthy Volunteers With an Open-label, Randomized, Cross-over Evaluation: The AMPHORE Study
Following a first, dose ascending study that enrolled 144 normal healthy volunteers (NHVs), this study, to be conducted in approximately 36 NHVs, will provide pertinent information in determining the dose-response of MDCO-157 for platelet aggregation inhibition and P2Y12 receptor inhibition effects and in selection of doses that match the antiplatelet effects of 300 mg PLAVIX® ®.
The study will also provide additional data for pharmacokinetics (PK), safety and tolerability of single doses of MDCO-157.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
37
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Paris, France
- Groupe Hospitalier Pitie-Salpetriere
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
- Healthy males or females 18 to 45 years of age, inclusive.
- Provide written informed consent for genetic testing and written informed consent for the study before initiation of any study related procedures
- Affiliated to the French social security system
- Screening and baseline Fridericia's correction (QTcF) interval < 450 msec and baseline heart rate between 50 and 100 bpm (inclusive)
Exclusion Criteria:
- Known or suspected hypersensitivity or allergy to clopidogrel, Captisol, PLAVIX® , or its excipients
- Body mass index <20 or > 30 kg/m²
- Inability to communicate with the investigator or comply with study related procedures, or high likelihood of being lost to follow up
- Known or suspected pregnancy or lactating female
- Medical history, physical examination including 12-lead ECG or laboratory evaluation conducted at the screening visit with results indicative of any disease or condition which might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk
- Tobacco product use within the last 6 months prior to dosing
- Platelet count < 150,000/µL
- A personal or family history of coagulation or bleeding disorders or reasonable suspicion of vascular malformations
- Active pathological bleeding such as peptic ulcer or intracranial hemorrhage
- Positive screen for Hepatitis B (Hepatitis B Surface Antigen HBsAg), Hepatitis C (Hepatitis C Antibody), or HIV (anti-HIV 1/2)
- Received an investigational drug within a period of 30 days or 5 half-lives, whichever is longer, prior to enrollment in the study
- Use of aspirin, other non-steroidal anti-inflammatory drugs, CYP3A4 inhibitors (ketoconazole), CYP2C19 inhibitors (eg, omeprazole) or other drugs known to affect platelet function or coagulation within 14 days prior to receiving study drug (MDCO-157 or oral clopidogrel)
- Grapefruit within 10 days prior to receiving study drug (MDCO-157 or PLAVIX®)
- Use of any over-the-counter medication, including herbal products, within 7 days prior to administration of study drug (MDCO-157 or PLAVIX®), except for up to 2 grams of acetaminophen per day for up to 3 days for pain control
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 75mg MDCO-157
iv
|
intravenous administration
|
Active Comparator: 150mg MDCO-157
iv
|
intravenous administration
|
Active Comparator: 300mg MDCO-157
iv
|
intravenous administration
|
Active Comparator: 300mg PLAVIX
oral
|
oral administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose Response of MDCO-157 (3 doses) compared to Plavix 300 mg
Time Frame: 24 hr
|
To evaluate the dose-response of MDCO-157 (at 3 doses) compared to Plavix (300 mg), using Emax and AUEC with VASP, over 24 hours:
|
24 hr
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics (PK) of MDCO-157 and its metabolites
Time Frame: 24 hrs
|
To determine the pharmacokinetic (PK) of MDCO-157, including clopidogrel, clopidogrel carboxylic acid, and clopidogrel H4 thiol active metabolite in plasma
|
24 hrs
|
Safety and tolerability
Time Frame: 48 hrs post each treatment period
|
To assess the safety and tolerability of single doses of MDCO 157 (75 mg, 150mg and 300mg) as measured by assessment of AEs and SAEs.
|
48 hrs post each treatment period
|
Dose response of MDCO-157 as assessed by LTA
Time Frame: 24 hours
|
24 hours
|
|
Dose response of MDCO-157 as assess by VerifyNow P2Y12 assay
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
September 12, 2012
First Submitted That Met QC Criteria
May 20, 2013
First Posted (Estimate)
May 22, 2013
Study Record Updates
Last Update Posted (Actual)
February 22, 2018
Last Update Submitted That Met QC Criteria
February 19, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MDCO-157-12-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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