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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.

NCT01647620 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-02-24

No results posted yet for this study

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. 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.

Conditions

  • Deep Vein Thrombosis Leg
  • Stroke (in Patients With Atrial Fibrillation)

Interventions

DRUG

DPOC-4088

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.

DRUG

Placebo

A 10-day oral dosing of matching placebo prolonged release tablet.

Sponsors & Collaborators

  • University Ghent

    collaborator OTHER

  • Kinesis Pharma B.V.

    collaborator INDUSTRY

  • Diakron Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Luc M van Bortel, Prof. Dr. · University Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01647620 on ClinicalTrials.gov