Pharmacokinetics and Pharmacodynamics in Healthy VolunteersPhase 1AMPHORENCT01860105
Appraisal of MDCO-157 and Plavix® Pharmacokinetics and Pharmacodynamics in Healthy Volunteers With an Evaluation
A Phase 1 study testing MDCO-157 and PLAVIX in people with Pharmacokinetics and Pharmacodynamics in Healthy Volunteers, run by The Medicines Company at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics and Pharmacodynamics in Healthy Volunteers
- What is being tested?
- MDCO-157 and PLAVIX
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to Jan 2013
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- MDCO-157, PLAVIX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDCO-157Drug
intravenous administration
PLAVIXDrug
oral administration
| Study group | Role | What they receive |
|---|---|---|
| 75mg MDCO-157 | Active comparator | iv Receives: Drug: MDCO-157 |
| 150mg MDCO-157 | Active comparator | iv Receives: Drug: MDCO-157 |
| 300mg MDCO-157 | Active comparator | iv Receives: Drug: MDCO-157 |
| 300mg PLAVIX | Active comparator | oral Receives: Drug: PLAVIX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Response of MDCO-157 (3 doses) compared to Plavix 300 mg
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:
- Maximum effect of P2Y12 receptor inhibition (Emax) using VASP (flow cytometry)
- Area under the effect of P2Y12 receptor inhibition time curve (AUEC) using VASP (flow cytometry)
Measured: 24 hr
Secondary outcomes (4)
Pharmacokinetics (PK) of MDCO-157 and its metabolites
To determine the pharmacokinetic (PK) of MDCO-157, including clopidogrel, clopidogrel carboxylic acid, and clopidogrel H4 thiol active metabolite in plasma
Measured: 24 hrs
Safety and tolerability
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.
Measured: 48 hrs post each treatment period
Dose response of MDCO-157 as assessed by LTA
Measured: 24 hours
Dose response of MDCO-157 as assess by VerifyNow P2Y12 assay
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startSep 2012
- Primary completionJan 2013
- Study completionJan 2013
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 Pharmacokinetics and Pharmacodynamics in Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Medicines Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860105
- Sponsor's protocol ID
- MDCO-157-12-01
- Acronym
- AMPHORE
- Status last verified
- Feb 2018
- First submitted
- 12 Sep 2012
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Collet JP, Funck-Brentano C, Prats J, Salem JE, Hulot JS, Guilloux E, Hu MY, He K, Silvain J, Gallois V, Brugier D, Anzaha G, Galier S, Nicolas N, Montalescot G. Intravenous Clopidogrel (MDCO-157) Compared with Oral Clopidogrel: The Randomized Cross-Over AMPHORE Study. Am J Cardiovasc Drugs. 2016 Feb;16(1):43-53. doi: 10.1007/s40256-015-0145-0.
PubMed 26386578
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appraisal of MDCO-157 and Plavix® Pharmacokinetics and Pharmacodynamics in Healthy Volunteers With an Open-label, Randomized, Cross-over Evaluation: The AMPHORE Study
- ClinicalTrials.gov ID
- NCT01860105
- Acronym / sponsor ID
- AMPHORE / MDCO-157-12-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- The Medicines CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 22 May 2013 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 75mg MDCO-157 | Active comparator | Drug: MDCO-157iv |
| 150mg MDCO-157 | Active comparator | Drug: MDCO-157iv |
| 300mg MDCO-157 | Active comparator | Drug: MDCO-157iv |
| 300mg PLAVIX | Active comparator | Drug: PLAVIXoral |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| MDCO-157intravenous administration | Drug | 150mg MDCO-157, 300mg MDCO-157, 75mg MDCO-157 |
| PLAVIXoral administration | Drug | 300mg PLAVIX |
Primary outcome
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: * Maximum effect of P2Y12 receptor inhibition (Emax) using VASP (flow cytometry) * Area under the effect of P2Y12 receptor inhibition time curve (AUEC) using VASP (flow cytometry)
4 secondary outcomes
Pharmacokinetics (PK) of MDCO-157 and its metabolites
Time frame: 24 hrs
Safety and tolerability
Time frame: 48 hrs post each treatment period
Dose response of MDCO-157 as assessed by LTA
Time frame: 24 hours
Dose response of MDCO-157 as assess by VerifyNow P2Y12 assay
Time frame: 24 hours
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 22 Feb 2018.
- Derived from this study: PubMed 26386578Collet JP, Funck-Brentano C, Prats J, Salem JE, Hulot JS, Guilloux E, Hu MY, He K, Silvain J, Gallois V, Brugier D, Anzaha G, Galier S, Nicolas N, Montalescot G. Intravenous Clopidogrel (MDCO-157) Compared with Oral Clopidogrel: The Randomized Cross-Over AMPHORE Study. Am J Cardiovasc Drugs. 2016 Feb;16(1):43-53. doi: 10.1007/s40256-015-0145-0.
Related trials for Pharmacokinetics and Pharmacodynamics in Healthy Volunteers
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Not yet recruitingPhase 1
A Phase I Clinical Trial of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of UBT48128 Tablets in Healthy Participants
Overweight , Obesity
RecruitingPhase 1
FIH Study to Evaluate the Tolerability of PF-07832837 in Healthy Adults and Patients
Healthy Participants, Atopic Dermatitis
Active, not recruitingPhase 1
A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity or Overweight
Healthy Volunteers, Overweight or Obesity
RecruitingPhase 1
Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN2230 in Healthy Participants
Healthy Adult Participants
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.
The record lists no contact. Use the official record to reach the sponsor.
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 MDCO-157 and PLAVIX in people with Pharmacokinetics and Pharmacodynamics in Healthy Volunteers, run by The Medicines Company at 1 site in France.
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 4 inclusion and 14 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 22 Feb 2018. 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 France. 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?
Dose Response of MDCO-157 (3 doses) compared to Plavix 300 mg (time frame: 24 hr). 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 NCT01860105, 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 22 Feb 2018.