Deep Vein Thrombosis LegPhase 1NCT01647620
A Healthy Volunteer Study to Investigate the Blood Concentrations, the Effect on Blood Clotting and the Safety of Multiple Doses of DPOC-4088 Tablets in Different Doses.
A Phase 1 study testing DPOC-4088 in people with Deep Vein Thrombosis Leg and Stroke (in Patients With Atrial Fibrillation), run by Diakron Pharmaceuticals at 1 site in Belgium.
Trial summary
A study to investigate the concentrations of a new drug DPOC-4088 in blood, and to study the effect of this drug on blood clotting parameters. Furthermore the relation between the blood concentrations and the blood clotting effect will be investigated. Safety will be investigated as well. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Deep Vein Thrombosis Leg, Stroke (in Patients With Atrial Fibrillation)
- What is being tested?
- DPOC-4088
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2012to Sep 2012
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male between 18 to 50 years of age inclusive.
- Either a non- or a light-smoker (<5 cigarettes per day) and agrees to refrain from smoking from the evening prior to first dosing until after the last PK sample of each step is drawn.
- Body-mass index (BMI) of 18-32 kg/m2.
- In good health on the basis of history, physical examination, and routine laboratory data.
- Understands the procedures and agrees to participate in the study program by giving written informed consent.
- Coagulation tests including aPTT, ECT, TT and PT within the reference range and a platelet count >145,000/mm3.
- At screening, normal transaminases and negative Hemoccult Sensa(R) test. In the event of a positive Hemoccult test, the test should be repeated twice. If the results of both repeats tests are negative, the first Hemoccult test result is considered a false positive and the subject may be included.
Who cannot join
- Mentally or legally incapacitated, significant emotional problems at the time of the study, or a history of psychiatric disorders within the last 10 years.
- History within the last 10 years of asthma or other pulmonary disease, major cardiovascular, hepatic, endocrine (including diabetes), rheumatological, or renal disease or of prior spine or disc surgery.
- History within the last 10 years of neurologic disease including stroke, transient ischemic attacks, seizure, head trauma, neurological tumors, brain or spinal cord surgery, neuropathy, or neuromuscular illness.
- Active gastrointestinal disease including: peptic ulcer disease, gastritis, clinically significant Helicobacter pylori infection, inflammatory bowel disease, diverticular disease, colonic polyps, or of any gastrointestinal malignancy, or recent (within 3 weeks) benign enteritis.
- History of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering study drug to the subject (e.g., surgery within the previous 3 months).
- Donated a unit of blood (450 mL) or participated in another clinical study drug trial within the 4 weeks prior to screening.
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- Family or personal history of bleeding disorders, including von Willebrand's disease.
- History of significant gingivitis or other periodontal disease.
- Received any prescription anticoagulant within the 30 days preceding screening including but not limited to warfarin, heparin, low-molecular weight heparin, hirulog, hirudin, argatroban, or dabigatran.
- Has received 14 days prior to first dosing or anticipates needing during the study any prescription or nonprescription (including over the counter) preparation that contains aspirin (including low-dose aspirin), ibuprofen, indomethacin, diclofenac, naproxen, meloxicam, any other NSAID or NSAID-containing product such as pain relievers, cold or sinus remedies, or any other drug which influences platelet aggregation.
- Received any investigational drug within the 30 days preceding screening.
- Regular user of any medication (including over-the-counter medication) for 14 days prior to first dosing, except for acetaminophen. Subject currently uses prescription or nonprescription drugs on a regular basis which cannot be discontinued for 14 days prior to first dosing until the last study visit (including "recreational use" of illicit drugs). Subject has a recent history (within the last 2 years) of drug or alcohol abuse.
- Subjects unable to stop using the following medications during the study (from first dosing until after the last study visit): erythromycin or erythromycin-like drugs, clarithromycin, diltiazem, cimetidine, warfarin-like anticoagulants, cyclosporine, itraconazole (or other systemic antifungal agents in the azole class), nefazodone, selective serotonin reuptake inhibitors (SSRI antidepressants), benzodiazepines, any systemic immunosuppressive agents (including glucocorticoids), cisapride and the H1 antagonists terfenadine and astemizole, and HIV protease inhibitors.
- Unable to refrain from the use of antacids, H2 blockers, sucralfate, or proton pump inhibitors beginning 14 days prior to first dosing until the last study visit.
- Has had major surgery within previous 3 months prior to first dosing or is anticipated to have major surgery within 2 weeks after completion of the study.
- Positive hepatitis serology (HBsAg and anti-HCV) showing any sign of active hepatitis.
- History of any chronic and/or active hepatic disease including hepatitis or biliary tract disease. Any subject with a history of hepatitis B or C at screening will be excluded. Subjects with a history of self-limited hepatitis A with complete resolutions documented at ≥12 months prior to entry would be eligible for inclusion.
- HIV positive.
- Significant unexplained and/or reproducible abnormalities on pre-study clinical examination or laboratory measurements.
- History of significant drug allergy or any clinically significant adverse event of a serious nature related to the administration of either a marketed or investigational drug.
- Known history of fainting from phlebotomy or from minor trauma resulting in bleeding.
- Habitual heavy consumer of coffee (more than 6 cups of coffee/day).
- Unable to refrain from consumption of grapefruit or grapefruit juice for at least 14 days prior to first dosing until the last study visit.
- Unable to refrain from the use of St. Johns wort for at least 14 days prior to first dosing until the last study visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Stepwise Study of the Pharmacokinetics (PK), Pharmacodynamics (PD), PK/PD Characteristics and Safety of Multiple Once-daily Oral Dosing of DPOC-4088 in Healthy Young Male Subjects
A study to investigate the concentrations of a new drug DPOC-4088 in blood, and to study the effect of this drug on blood clotting parameters. Furthermore the relation between the blood concentrations and the blood clotting effect will be investigated. Safety will be investigated as well. The objective of these investigations is to determine the optimal dose of DPOC-4088 that, achieves a relevant increase in a specific blood clotting parameter (the ecarin clotting time) without safety concerns.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, stepwise study of multiple once-daily oral dosing of DPOC-4088 (100 mg in Step 1) in healthy young male subjects. Each Step of the study will include 10 subjects and consist of screening for eligibility followed by a 13-day period during which once-daily oral doses of DPOC-4088 or placebo are administered for 10 consecutive days and blood is sampled for PK/PD measurements.
In each dose step, 8 subjects will receive active drug and 2 subjects will receive matching placebo according to a randomized allocation schedule.
During each Step, DPOC-4088 or placebo will be given each morning on Days 1 through 10, safety permitting. Each of the 10 days of dosing will be preceded by an overnight fast (10 hours). Subjects will have frequent PK/PD sampling performed for a 24 hour period following dosing on Day 1 and for a 72-hour period following dosing on Day 10. On Days 1 and 10, the first meal will be given at 4 hours post-dosing. On other dosing days, subjects will not have breakfast until one hour after dosing. Blood samples will be drawn for PK and PD evaluations immediately prior to dosing and at specified time intervals post-dosing. Following completion of all 10 days of dosing in each Step, subjects will return for a follow-up examination in 1 week (7-9 days).
After completion of all dosing in Step 1, PK, PD and safety data will be analyzed and (if necessary) used to determine the dose for Step 2, the same procedure will be followed for the next dose steps, if necessary.
The safety, tolerability, and the PK profile of DPOC-4088 will be assessed. Additionally, this study will assess the PD profile and the relationship of PK/PD in terms of the ability of DPOC-4088 to inhibit thrombin activity (based on prolongation of aPTT, ECT, TT and PT).
To main objective is to determine the dose of DPOC-4088 that, following multiple once-daily oral dosing, achieves a target increase of 2-fold over baseline in the ecarin clotting time (ECT) at the steady-state trough plasma concentration (Cmin-ss) without safety concerns.
- Being tested
- DPOC-4088, Placebo
- Medical subject headings
- Venous Thrombosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPOC-4088Drug
A 10-day oral dosing of DPOC-4088 prolonged release tablet (20 hr release formulation). Starting dose in dose step 1 is 100 mg daily.
PlaceboDrug
A 10-day oral dosing of matching placebo prolonged release tablet.
| Study group | Role | What they receive |
|---|---|---|
| DPOC-4088 | Active comparator | A 10-day oral dosing of DPOC-4088 prolonged release tablet (20 hr release formulation). Starting dose in dose step 1 is 100 mg daily Receives: Drug: DPOC-4088 |
| Placebo | Placebo comparator | A 10-day oral dosing of matching placebo prolonged release tablet. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The dose of DPOC-4088 that, following multiple once-daily oral dosing, achieves a target increase of 2-fold over baseline in the ecarin clotting time (ECT) at the steady-state trough plasma concentration (Cmin-ss) without safety concerns
Secondary outcomes (4)
The dose of DPOC-4088 that, following multiple once-daily oral dosing, achieves a target increase of 1.5-fold over baseline in the activated partial thromboplastin time (aPTT) at Cmin-ss without safety concerns.
The extent and duration (at the end of dosing) of inhibition of coagulation parameters as measured by the change from baseline in ECT and aPTT.
The DPOC-4088 plasma concentration vs time profile and Cmax-ss/Cmin-ss following multiple once-daily oral dosing.
The safety of DPOC-4088 given once-daily for 10 days.
Vital sign measurements, 12-lead ECGs, physical examinations, laboratory and adverse events.
A complete physical examination and a brief neurological examination will be performed pre-study and post-study. On Days 2, 4, 5, 7, and 10, the physical examination is limited to examination of the skin for evidence of bleeding, bruising or petechiae.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2012
- Study completionSep 2012
Why it stopped: Diakron Pharmaceuticals couldn't fulfill the financial responsibility of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein Thrombosis LegStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diakron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Ghent, Kinesis Pharma B.V.
- Responsible party
- Sponsor
- Investigators
- Luc M van Bortel, Prof. Dr., Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647620
- Sponsor's protocol ID
- DPOC-002
- Status last verified
- Jul 2012
- First submitted
- 19 Jul 2012
- Last updated
- 24 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Stepwise Study of the Pharmacokinetics (PK), Pharmacodynamics (PD), PK/PD Characteristics and Safety of Multiple Once-daily Oral Dosing of DPOC-4088 in Healthy Young Male Subjects
- ClinicalTrials.gov ID
- NCT01647620
- Acronym / sponsor ID
- DPOC-002
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Diakron Pharmaceuticals couldn't fulfill the financial responsibility of the study
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Diakron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- University Ghent, Kinesis Pharma B.V.
- Study start
- Feb 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 23 Jul 2012 (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.
A study to investigate the concentrations of a new drug DPOC-4088 in blood, and to study the effect of this drug on blood clotting parameters. Furthermore the relation between the blood concentrations and the blood clotting effect will be investigated. Safety will be investigated as well. The objective of these investigations is to determine the optimal dose of DPOC-4088 that, achieves a relevant increase in a specific blood clotting parameter (the ecarin clotting time) without safety concerns.
Detailed description
This is a randomized, double-blind, placebo-controlled, stepwise study of multiple once-daily oral dosing of DPOC-4088 (100 mg in Step 1) in healthy young male subjects. Each Step of the study will include 10 subjects and consist of screening for eligibility followed by a 13-day period during which once-daily oral doses of DPOC-4088 or placebo are administered for 10 consecutive days and blood is sampled for PK/PD measurements.
In each dose step, 8 subjects will receive active drug and 2 subjects will receive matching placebo according to a randomized allocation schedule.
During each Step, DPOC-4088 or placebo will be given each morning on Days 1 through 10, safety permitting. Each of the 10 days of dosing will be preceded by an overnight fast (10 hours). Subjects will have frequent PK/PD sampling performed for a 24 hour period following dosing on Day 1 and for a 72-hour period following dosing on Day 10. On Days 1 and 10, the first meal will be given at 4 hours post-dosing. On other dosing days, subjects will not have breakfast until one hour after dosing. Blood samples will be drawn for PK and PD evaluations immediately prior to dosing and at specified time intervals post-dosing. Following completion of all 10 days of dosing in each Step, subjects will return for a follow-up examination in 1 week (7-9 days).
After completion of all dosing in Step 1, PK, PD and safety data will be analyzed and (if necessary) used to determine the dose for Step 2, the same procedure will be followed for the next dose steps, if necessary.
The safety, tolerability, and the PK profile of DPOC-4088 will be assessed. Additionally, this study will assess the PD profile and the relationship of PK/PD in terms of the ability of DPOC-4088 to inhibit thrombin activity (based on prolongation of aPTT, ECT, TT and PT).
To main objective is to determine the dose of DPOC-4088 that, following multiple once-daily oral dosing, achieves a target increase of 2-fold over baseline in the ecarin clotting time (ECT) at the steady-state trough plasma concentration (Cmin-ss) without safety concerns.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DPOC-4088 | Active comparator | Drug: DPOC-4088A 10-day oral dosing of DPOC-4088 prolonged release tablet (20 hr release formulation). Starting dose in dose step 1 is 100 mg daily |
| Placebo | Placebo comparator | Drug: PlaceboA 10-day oral dosing of matching placebo prolonged release tablet. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male between 18 to 50 years of age inclusive.
- Either a non- or a light-smoker (<5 cigarettes per day) and agrees to refrain from smoking from the evening prior to first dosing until after the last PK sample of each step is drawn.
- Body-mass index (BMI) of 18-32 kg/m2.
- In good health on the basis of history, physical examination, and routine laboratory data.
- Understands the procedures and agrees to participate in the study program by giving written informed consent.
Key exclusion criteria (24 listed)
- Mentally or legally incapacitated, significant emotional problems at the time of the study, or a history of psychiatric disorders within the last 10 years.
- History within the last 10 years of asthma or other pulmonary disease, major cardiovascular, hepatic, endocrine (including diabetes), rheumatological, or renal disease or of prior spine or disc surgery.
- History within the last 10 years of neurologic disease including stroke, transient ischemic attacks, seizure, head trauma, neurological tumors, brain or spinal cord surgery, neuropathy, or neuromuscular illness.
- Active gastrointestinal disease including: peptic ulcer disease, gastritis, clinically significant Helicobacter pylori infection, inflammatory bowel disease, diverticular disease, colonic polyps, or of any gastrointestinal malignancy, or recent (within 3 weeks) benign enteritis.
- History of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering study drug to the subject (e.g., surgery within the previous 3 months).
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 |
|---|---|---|
| DPOC-4088A 10-day oral dosing of DPOC-4088 prolonged release tablet (20 hr release formulation). Starting dose in dose step 1 is 100 mg daily. | Drug | DPOC-4088 |
| PlaceboA 10-day oral dosing of matching placebo prolonged release tablet. | Drug | Placebo |
Primary outcome
The dose of DPOC-4088 that, following multiple once-daily oral dosing, achieves a target increase of 2-fold over baseline in the ecarin clotting time (ECT) at the steady-state trough plasma concentration (Cmin-ss) without safety concerns
4 secondary outcomes
The dose of DPOC-4088 that, following multiple once-daily oral dosing, achieves a target increase of 1.5-fold over baseline in the activated partial thromboplastin time (aPTT) at Cmin-ss without safety concerns.
The extent and duration (at the end of dosing) of inhibition of coagulation parameters as measured by the change from baseline in ECT and aPTT.
The DPOC-4088 plasma concentration vs time profile and Cmax-ss/Cmin-ss following multiple once-daily oral dosing.
The safety of DPOC-4088 given once-daily for 10 days.
Results and safety
The study was stopped early (reason given: Diakron Pharmaceuticals couldn't fulfill the financial responsibility of the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2015.
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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.
Luc M van Bortel, Prof. Dr. principal investigator
University Ghent
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 DPOC-4088 in people with Deep Vein Thrombosis Leg and Stroke (in Patients With Atrial Fibrillation), run by Diakron Pharmaceuticals at 1 site in Belgium.
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 7 inclusion and 24 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: stopped early, as of the sponsor's last update on 24 Feb 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 Belgium. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Diakron Pharmaceuticals couldn't fulfill the financial responsibility of the study). Results are not available in the source record.
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?
The dose of DPOC-4088 that, following multiple once-daily oral dosing, achieves a target increase of 2-fold over baseline in the ecarin clotting time (ECT) at the steady-state trough plasma concentration (Cmin-ss) without safety concerns. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2015.