NCT01347203

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 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Diakron Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DRUG	DPOC-4088	A single oral dose of DPOC-4088 prolonged release tablet 100 mg (Formulation A = 16 hr release formulation)
DRUG	DPOC-4088	A single oral dose of DPOC-4088 prolonged release tablet 200 mg (Formulation A = 16 hr release formulation)
DRUG	DPOC-4088	A single oral dose of DPOC-4088 prolonged release tablet 100 mg (Formulation B = 20 hr release formulation)
DRUG	DPOC-4088	A single oral dose of DPOC-4088 prolonged release tablet 200 mg (Formulation B = 20 hr release formulation)

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2011-05-04
• Last updated: 2011-07-07

Locations

1 site across 1 country: Belgium