Deep Vein Thrombosis LegPhase 1NCT01347203
A Healthy Volunteer Study to Evaluate for a Single Dose of 4 Different Tablets of DPOC-4088 the Absorption and Elimination From the Body and the Potential Effect on Blood Clotting
A Phase 1 study testing DPOC-4088 in people with Deep Vein Thrombosis Leg, run by Diakron Pharmaceuticals at 1 site in Belgium.
Trial summary
This will be a study existing of 4 periods, to evaluate for a single dose of 4 different tablets of DPOC-4088 the absorption and elimination from the body and the potential effect on blood clotting. 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
- Deep Vein Thrombosis Leg
- What is being tested?
- DPOC-4088
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2011to Jun 2011
- 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
- Male between 18 to 45 years of age.
- Either a non- or a light-smoker (<5 cigarettes per day) and agrees to refrain from smoking during the entire 4-week study until after the last PK sample is drawn.
- Body-mass index (BMI) of 18-30 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 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.
- 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.
Show all 23Show fewer
- 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 minor or major surgery (including dental surgery) within previous 3 months prior to first dosing or is anticipated to have minor or major surgery (including dental 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.
- Significant unexplained and/or reproducible abnormalities on prestudy 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, Open-label, 4-period Crossover Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD) and the PK/PD Relationship of DPOC-4088 After Single Oral Dosing of 100 and 200 mg in 2 Prolonged Release Formulations (16 and 20 hr) in 12 Healthy Young Male Subjects
This will be a study existing of 4 periods, to evaluate for a single dose of 4 different tablets of DPOC-4088 the absorption and elimination from the body and the potential effect on blood clotting. The differences between the tablets are the dose (100 or 200 mg) and the rate of release of DPOC-4088 from the tablet (16 or 20 hours). The allocation of the tablets in each period will be determined by chance but is known upfront.
Read the detailed description
This will be a randomized, open-label, single oral dose study. The 4-period crossover study will determine and compare the PK and PD profiles of DPOC-4088 when administered as a single oral dose of 100 mg and 200 mg of DPOC-4088 in two prolonged release formulations (16 and 20 hr) in 12 evaluable young healthy male subjects.
Each subject (in a fasting state) will receive each of the 4 treatments (A, B, C, and D) in a balanced, 4-period crossover design. Each treatment consists of a single oral dose of 100 mg or 200 mg of DPOC-4088 in either prolonged release formulation (16 or 20 hr). Subjects will arrive at the study unit for an overnight fast of at least 10 hrs the evening before each dosing period and remain in the unit for at least 24 hrs after dosing. Standard meals will be provided and subjects will receive their first meal after dosing at 4 hrs post-dose. Blood samples will be drawn for PK and PD evaluations immediately prior to dosing and at specified time intervals for 48 hrs post-dosing. Each dosing period will be separated by at least a 5-day washout period that is preferentially not to exceed 10 days.
In healthy young male subjects, 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).
- Conditions
- Deep Vein Thrombosis Leg
- Being tested
- DPOC-4088
- Keywords
- phase I, healthy volunteers, crossover study, pharmacokinetics, pharmacodynamics
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPOC-4088Drug
A single oral dose of DPOC-4088 prolonged release tablet 100 mg (Formulation A = 16 hr release formulation)
DPOC-4088Drug
A single oral dose of DPOC-4088 prolonged release tablet 200 mg (Formulation A = 16 hr release formulation)
DPOC-4088Drug
A single oral dose of DPOC-4088 prolonged release tablet 100 mg (Formulation B = 20 hr release formulation)
DPOC-4088Drug
A single oral dose of DPOC-4088 prolonged release tablet 200 mg (Formulation B = 20 hr release formulation)
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | DPOC-4088 prolonged release tablet 100 mg (Formulation A= 16 hr release formulation) Receives: Drug: DPOC-4088 |
| Treatment B | Experimental | DPOC-4088 prolonged release tablet 200 mg (Formulation A= 16 hr release formulation) Receives: Drug: DPOC-4088 |
| Treatment C | Experimental | DPOC-4088 prolonged release tablet 100 mg (Formulation B= 20 hr release formulation) Receives: Drug: DPOC-4088 |
| Treatment D | Experimental | DPOC-4088 prolonged release tablet 200 mg (Formulation B= 20 hr release formulation) Receives: Drug: DPOC-4088 |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma concentration ratios
Cmax/C12 hr and Cmax/C24 hr for each of the 2 doses and 2 prolonged release formulations of DPOC-4088
Measured: pre-dose until 48 hrs post-dose
Secondary outcomes (3)
other pharmacokinetics
AUC 0-48 hr, AUC0-∞, Cmax, C12 hr, C24 hr, Tmax, T1/2
Measured: pre-dose until 48 hrs post-dose
blood coagulation
aPTT, ECT, TT and PT
Measured: pre-dose until 48 hrs post-dose
safety
adverse events and abnormal laboratory findings
Measured: throughout clinical trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2011
- Study completionJun 2011
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
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diakron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Luc M Van Bortel, Prof. dr., Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347203
- Sponsor's protocol ID
- DPOC-001
- Status last verified
- Jul 2011
- First submitted
- 2 May 2011
- Last updated
- 7 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, 4-period Crossover Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD) and the PK/PD Relationship of DPOC-4088 After Single Oral Dosing of 100 and 200 mg in 2 Prolonged Release Formulations (16 and 20 hr) in 12 Healthy Young Male Subjects
- ClinicalTrials.gov ID
- NCT01347203
- Acronym / sponsor ID
- DPOC-001
- Conditions
- Deep Vein Thrombosis Leg
- Keywords
- phase I, healthy volunteers, crossover study, pharmacokinetics, pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Diakron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 4 May 2011 (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.
This will be a study existing of 4 periods, to evaluate for a single dose of 4 different tablets of DPOC-4088 the absorption and elimination from the body and the potential effect on blood clotting. The differences between the tablets are the dose (100 or 200 mg) and the rate of release of DPOC-4088 from the tablet (16 or 20 hours). The allocation of the tablets in each period will be determined by chance but is known upfront.
Detailed description
This will be a randomized, open-label, single oral dose study. The 4-period crossover study will determine and compare the PK and PD profiles of DPOC-4088 when administered as a single oral dose of 100 mg and 200 mg of DPOC-4088 in two prolonged release formulations (16 and 20 hr) in 12 evaluable young healthy male subjects.
Each subject (in a fasting state) will receive each of the 4 treatments (A, B, C, and D) in a balanced, 4-period crossover design. Each treatment consists of a single oral dose of 100 mg or 200 mg of DPOC-4088 in either prolonged release formulation (16 or 20 hr). Subjects will arrive at the study unit for an overnight fast of at least 10 hrs the evening before each dosing period and remain in the unit for at least 24 hrs after dosing. Standard meals will be provided and subjects will receive their first meal after dosing at 4 hrs post-dose. Blood samples will be drawn for PK and PD evaluations immediately prior to dosing and at specified time intervals for 48 hrs post-dosing. Each dosing period will be separated by at least a 5-day washout period that is preferentially not to exceed 10 days.
In healthy young male subjects, 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: DPOC-4088DPOC-4088 prolonged release tablet 100 mg (Formulation A= 16 hr release formulation) |
| Treatment B | Experimental | Drug: DPOC-4088DPOC-4088 prolonged release tablet 200 mg (Formulation A= 16 hr release formulation) |
| Treatment C | Experimental | Drug: DPOC-4088DPOC-4088 prolonged release tablet 100 mg (Formulation B= 20 hr release formulation) |
| Treatment D | Experimental | Drug: DPOC-4088DPOC-4088 prolonged release tablet 200 mg (Formulation B= 20 hr release formulation) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male between 18 to 45 years of age.
- Either a non- or a light-smoker (<5 cigarettes per day) and agrees to refrain from smoking during the entire 4-week study until after the last PK sample is drawn.
- Body-mass index (BMI) of 18-30 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 (23 listed)
- Mentally or legally incapacitated, significant emotional problems at the time of the study, or a history of psychiatric disorders.
- 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 single oral dose of DPOC-4088 prolonged release tablet 100 mg (Formulation A = 16 hr release formulation) | Drug | Treatment A |
| DPOC-4088A single oral dose of DPOC-4088 prolonged release tablet 200 mg (Formulation A = 16 hr release formulation) | Drug | Treatment B |
| DPOC-4088A single oral dose of DPOC-4088 prolonged release tablet 100 mg (Formulation B = 20 hr release formulation) | Drug | Treatment C |
| DPOC-4088A single oral dose of DPOC-4088 prolonged release tablet 200 mg (Formulation B = 20 hr release formulation) | Drug | Treatment D |
Primary outcome
plasma concentration ratios
Time frame: pre-dose until 48 hrs post-dose
Cmax/C12 hr and Cmax/C24 hr for each of the 2 doses and 2 prolonged release formulations of DPOC-4088
3 secondary outcomes
other pharmacokinetics
Time frame: pre-dose until 48 hrs post-dose
blood coagulation
Time frame: pre-dose until 48 hrs post-dose
safety
Time frame: throughout clinical trial
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 7 Jul 2011.
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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, 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 23 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 7 Jul 2011. 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. 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?
plasma concentration ratios (time frame: pre-dose until 48 hrs post-dose). 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 7 Jul 2011.