ThrombosisPhase 1PR-15/01NCT01042964
Safety, Pharmacokinetic and -Dynamic Study of PR-15, an Inhibitor of Platelet Adhesion
A Phase 1 study testing revacept (PR-15) in people with Thrombosis and Acute Coronary Syndrome, run by AdvanceCor GmbH at 1 site in Germany.
Trial summary
Primary objective: To evaluate safety and tolerability, adverse events (AEs), vital signs, ECG, bleeding time, evaluation of antibody titer and safety laboratory tests Secondary objectives: To evaluate the pharmacokinetics and pharmacodynamics (platelet aggregation)of six ascending single intravenous doses of PR-15 in… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Thrombosis, Acute Coronary Syndrome, Myocardial Infarction
- What is being tested?
- revacept (PR-15)
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2006to Oct 2007
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, male Caucasians between 18 and 45 years of age.
- Normotensive subjects (systolic BP < 140 mmHg and diastolic BP <90 mmHg;
- Body weight of 70 to 90 kg (BMI 20 - 25.
- Negative results in HIV antibody, HBs antigen (HBsAg) and HCV tests;
- Signed Informed Consent Form.
- Normal coagulation function (aPTT between 24 and 35 seconds, PT between 70 and 130%, INR between 0.85 and 1.15.
Who cannot join
- Subjects who are taking or have taken any prescription medication within the last 14 days or any non-prescription medication, especially, anti-platelet drugs, within the last seven days prior to the administration of trial medication on Day 1.
- Intake of any investigational drug within three months prior to the administration of study medication on Day 1.
- Concomitant use of any other medication including over-the-counter preparations.
- History of hypersensitivity, contraindication or serious adverse reaction to inhibitors of platelet aggregation or hypersensitivity to related drugs (cross-allergy) or to any of the excipients in the study drug.
- A history or clinical evidence of any cardiac, cardio- or cerebrovascular, hepatic, renal, pulmonary, endocrine, neurological, infectious, gastrointestinal, haematological, oncological or psychiatric disease or emotional problems or any other clinically relevant condition, physical finding, ECG- or laboratory test abnormality, which - in the opinion of the investigator - would pose a significant risk for the subject, invalidate the Informed Consent or limit the ability of the subject to comply with study requirements or interfere otherwise with the conduct of the study.
- Any laboratory value outside the normal laboratory reference range at Screening and before randomization, unless approved by the investigator.
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- Subjects known to have experienced elevated liver enzyme values will also be excluded.
- History of alcohol and/or drug abuse (verified by drug screening).
- Blood loss of 450 ml or more during the last three months before Screening.
- Subjects who smoke more than 5 cigarettes per day and/or are unable to abstain from smoking during the entire in-house period.
- Subjects who were previously enrolled in this trial or who have received PR-15 in a previous trial.
- Subjects who have participated in other clinical trials in the last 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Dose-Escalating Safety and Pharmacokinetic Study of an Acute Intravenous Administration of PR-15, an Inhibitor of Platelet Adhesion, in Six Different Strengths in Healthy Male Volunteers
Primary objective:
To evaluate safety and tolerability, adverse events (AEs), vital signs, ECG, bleeding time, evaluation of antibody titer and safety laboratory tests
Secondary objectives:
To evaluate the pharmacokinetics and pharmacodynamics (platelet aggregation)of six ascending single intravenous doses of PR-15 in healthy volunteers
Read the detailed description
Primary objective:
To evaluate safety and tolerability by using adverse events (AEs), vital signs including blood pressure/pulse rate (BP/PR), electrocardiographic examinations (12 lead ECG), bleeding time, evaluation of antibody titer and safety laboratory tests (biochemistry, hematology, coagulation, urinalysis)
Secondary objectives:
To evaluate the pharmacokinetics and pharmacodynamics (collagen-induced platelet aggregation)of six ascending single intravenous doses of PR-15 in healthy, male volunteers
- Conditions
- Thrombosis, Acute Coronary Syndrome, Myocardial Infarction, Stroke
- Being tested
- revacept (PR-15)
- Keywords
- platelet adhesion and aggregation, acute coronary syndrome, myocardial infarction, stroke, inhibition of platelet adhesion to plaques, collagen-induced platelet aggregation
- Medical subject headings
- Thrombosis, Acute Coronary Syndrome, Myocardial Infarction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
revacept (PR-15)Drug
Also called GPVI-Fc dimer
single intravenous administration of revacept (PR-15), an inhibitor of platelet adhesion, in various strengths (10, 20, 40, 80, 160 mg) in healthy male volunteers.
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability adverse events (AEs), vital signs (BP/PR), 12 lead ECG, bleeding time, antibody titer and safety laboratory tests
Measured: 43 days
Secondary outcomes (1)
pharmacokinetics and pharmacodynamics (agonist-induced platelet aggregation)
Measured: 43 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startMar 2006
- Primary completionJan 2007
- Study completionOct 2007
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 ThrombosisStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdvanceCor GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Procorde GmbH
- Responsible party
- Sponsor
- Investigators
- Richard Piechatzek, MD, Principal investigator, ABX-CRO/Medifacts GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042964
- Sponsor's protocol ID
- PR-15/01
- Other IDs
- EudraCT 2005-004656-12
- Acronym
- PR-15/01
- Status last verified
- Oct 2012
- First submitted
- 5 Jan 2010
- Last updated
- 19 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ungerer M, Rosport K, Bultmann A, Piechatzek R, Uhland K, Schlieper P, Gawaz M, Munch G. Novel antiplatelet drug revacept (Dimeric Glycoprotein VI-Fc) specifically and efficiently inhibited collagen-induced platelet aggregation without affecting general hemostasis in humans. Circulation. 2011 May 3;123(17):1891-9. doi: 10.1161/CIRCULATIONAHA.110.980623. Epub 2011 Apr 18.
PubMed 21502572
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Dose-Escalating Safety and Pharmacokinetic Study of an Acute Intravenous Administration of PR-15, an Inhibitor of Platelet Adhesion, in Six Different Strengths in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01042964
- Acronym / sponsor ID
- PR-15/01 / PR-15/01
- Conditions
- Thrombosis, Acute Coronary Syndrome, Myocardial Infarction, Stroke
- Keywords
- platelet adhesion and aggregation, acute coronary syndrome, myocardial infarction, stroke, inhibition of platelet adhesion to plaques, collagen-induced platelet aggregation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AdvanceCor GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Procorde GmbH
- Study start
- Mar 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 6 Jan 2010 (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.
Primary objective:
To evaluate safety and tolerability, adverse events (AEs), vital signs, ECG, bleeding time, evaluation of antibody titer and safety laboratory tests
Secondary objectives:
To evaluate the pharmacokinetics and pharmacodynamics (platelet aggregation)of six ascending single intravenous doses of PR-15 in healthy volunteers
Detailed description
Primary objective:
To evaluate safety and tolerability by using adverse events (AEs), vital signs including blood pressure/pulse rate (BP/PR), electrocardiographic examinations (12 lead ECG), bleeding time, evaluation of antibody titer and safety laboratory tests (biochemistry, hematology, coagulation, urinalysis)
Secondary objectives:
To evaluate the pharmacokinetics and pharmacodynamics (collagen-induced platelet aggregation)of six ascending single intravenous doses of PR-15 in healthy, male volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy, male Caucasians between 18 and 45 years of age.
- Normotensive subjects (systolic BP < 140 mmHg and diastolic BP <90 mmHg;
- Body weight of 70 to 90 kg (BMI 20 - 25.
- Negative results in HIV antibody, HBs antigen (HBsAg) and HCV tests;
- Signed Informed Consent Form.
Key exclusion criteria (12 listed)
- Subjects who are taking or have taken any prescription medication within the last 14 days or any non-prescription medication, especially, anti-platelet drugs, within the last seven days prior to the administration of trial medication on Day 1.
- Intake of any investigational drug within three months prior to the administration of study medication on Day 1.
- Concomitant use of any other medication including over-the-counter preparations.
- History of hypersensitivity, contraindication or serious adverse reaction to inhibitors of platelet aggregation or hypersensitivity to related drugs (cross-allergy) or to any of the excipients in the study drug.
- A history or clinical evidence of any cardiac, cardio- or cerebrovascular, hepatic, renal, pulmonary, endocrine, neurological, infectious, gastrointestinal, haematological, oncological or psychiatric disease or emotional problems or any other clinically relevant condition, physical finding, ECG- or laboratory test abnormality, which - in the opinion of the investigator - would pose a significant risk for the subject, invalidate the Informed Consent or limit the ability of the subject to comply with study requirements or interfere otherwise with the conduct of the study.
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 |
|---|---|---|
| revacept (PR-15)Also: GPVI-Fc dimersingle intravenous administration of revacept (PR-15), an inhibitor of platelet adhesion, in various strengths (10, 20, 40, 80, 160 mg) in healthy male volunteers. | Drug | – |
Primary outcome
safety and tolerability adverse events (AEs), vital signs (BP/PR), 12 lead ECG, bleeding time, antibody titer and safety laboratory tests
Time frame: 43 days
1 secondary outcome
pharmacokinetics and pharmacodynamics (agonist-induced platelet aggregation)
Time frame: 43 days
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 19 Oct 2012.
- Results publication: PubMed 21502572Ungerer M, Rosport K, Bultmann A, Piechatzek R, Uhland K, Schlieper P, Gawaz M, Munch G. Novel antiplatelet drug revacept (Dimeric Glycoprotein VI-Fc) specifically and efficiently inhibited collagen-induced platelet aggregation without affecting general hemostasis in humans. Circulation. 2011 May 3;123(17):1891-9. doi: 10.1161/CIRCULATIONAHA.110.980623. Epub 2011 Apr 18.
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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.
Richard Piechatzek, MD principal investigator
ABX-CRO/Medifacts GmbH
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 revacept (PR-15) in people with Thrombosis and Acute Coronary Syndrome, run by AdvanceCor GmbH at 1 site in Germany.
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 6 inclusion and 12 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 19 Oct 2012. 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 Germany. 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?
safety and tolerability adverse events (AEs), vital signs (BP/PR), 12 lead ECG, bleeding time, antibody titer and safety laboratory tests (time frame: 43 days). 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 NCT01042964, 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 19 Oct 2012.