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Safety and Dosing Evaluation of REG1 Anticoagulation System

NCT00113997 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2008-03-04

No results posted yet for this study

Summary

This 1-week study will test the safety and dosing of an anticoagulation system called REG1 that is designed to improve control of "blood thinning." Patients with heart attack and other conditions require treatment with an anticoagulant (blood thinner) to prevent the formation of blood clots. However, anticoagulation therapy can increase the risk of bleeding. The REG1 system is designed to minimize this risk. One part of the system stops the activity of factor IX (a protein that helps blood clot) while the other part of the system (the antidote) inactivates the drug and stops the thinning process. This study will examine in normal healthy subjects how the REG1 system works in the body and how it leaves the body.

Healthy normal volunteers between 12 and 65 years of age who weigh 50-120 kilograms (110-264 pounds) and have no history of bleeding problems or significant bleeding may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood tests.

Participants must avoid foods that may alter the blood's clotting ability and must not take any medications the week of the study. They undergo the following tests and procedures:

Day 1

Subjects are admitted to the NIH Clinical Center for an overnight stay. Two catheters (plastic tubes) are placed in the subject's arm veins, one for drawing blood samples and the other for injecting one of the following: REG1 drug, REG1 antidote, REG1 drug and antidote, or placebo. Two injections of study medication are given, spaced 3 hours apart, each over a 1-minute period. After each injection, blood is collected at specific times to measure levels of the drug or antidote in the body and the blood's ability to clot. Subjects also provide a 24-hour urine collection and stool sample.

Day 2

A blood sample is drawn 24 hours after the drug or antidote injection from the previous day. If the blood test result is normal, subjects are discharged home with instructions to follow. They return to the Clinical Center at 36 hours and 48 hours for additional blood samples.

Days 3 and 7

A blood sample is collected at the end of day 3 and day 7. Urine and stool samples are also collected.

Conditions

  • Healthy

Interventions

DRUG

REG1

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Study Design

Purpose
TREATMENT

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Completion
2005-10-31

Countries

  • United States

Study Locations

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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 NCT00113997 on ClinicalTrials.gov