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

NCT01347203 | Completed Phase 1

• 1 other identifier: DPOC-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Deep Vein Thrombosis Leg

Keywords

phase I; healthy volunteers; crossover study; pharmacokinetics; pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• plasma concentration ratios

  Cmax/C12 hr and Cmax/C24 hr for each of the 2 doses and 2 prolonged release formulations of DPOC-4088

  pre-dose until 48 hrs post-dose

Secondary Outcomes (3)

• other pharmacokinetics

  pre-dose until 48 hrs post-dose

• blood coagulation

  pre-dose until 48 hrs post-dose

• safety

  throughout clinical trial

Study Arms (4)

Treatment A

EXPERIMENTAL

DPOC-4088 prolonged release tablet 100 mg (Formulation A= 16 hr release formulation)

Drug: DPOC-4088

Treatment B

EXPERIMENTAL

DPOC-4088 prolonged release tablet 200 mg (Formulation A= 16 hr release formulation)

Drug: DPOC-4088

Treatment C

EXPERIMENTAL

DPOC-4088 prolonged release tablet 100 mg (Formulation B= 20 hr release formulation)

Drug: DPOC-4088

Treatment D

EXPERIMENTAL

DPOC-4088 prolonged release tablet 200 mg (Formulation B= 20 hr release formulation)

Drug: DPOC-4088

Interventions

DPOC-4088 DRUG

A single oral dose of DPOC-4088 prolonged release tablet 100 mg (Formulation A = 16 hr release formulation)

Treatment A

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Diakron Pharmaceuticals: lead

Study Sites (1)

Drug Reseach Unit Ghent

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Luc M Van Bortel, Prof. dr.

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 2, 2011
• First Posted: May 4, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 7, 2011

Record last verified: 2011-07

Locations

BE (1)