Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 in Healthy Volunteers

April 19, 2007 updated by: Archemix Corp.

A Phase 1, Single-Site, Double-Blind,Randomized, Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous Bolus or Intravenous Bolus Followed by Continuous Infusion Administration of ARC1779 Compared to Placebo in Healthy Volunteers

The purpose of this study is to establish the overall safety and tolerability of ARC1779 in healthy volunteers, and to characterize its pharmacokinetic and pharmacodynamic profile with respect to parameters of platelet function and von Willebrand Factor activity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to establish the overall safety and tolerability of ARC1779 in healthy volunteers, and to characterize its pharmacokinetic and pharmacodynamic profile with respect to parameters of platelet function and von Willebrand Factor activity.

Study Type

Interventional

Enrollment

42

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Bioanalytical Systems, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥ 18 to ≤ 65 years of age
  • Weight ≤ 110 kg
  • Negative qualitative urine drug/alcohol test
  • Female volunteers must be of non-childbearing potential
  • Male volunteers must agree to use a medically acceptable contraceptive
  • Volunteers must be capable of understanding and complying with the protocol and must have signed the informed consent document

Exclusion Criteria:

Any clinically significant medical disorder (e.g. diabetes, hypertension, etc.)

  • Tendency to bleed easily
  • History of recent trauma or surgery
  • History of gout or renal stones

Clinically significant abnormal lab parameters for the following:

  • PT INR > 1.4
  • aPTT > reference laboratory values
  • Serum creatinine > 1.3 mg/dL
  • Platelet count of ≤ 100,000/mm3
  • ALT/AST > 2 times ULN
  • WBC ≤ 3000 x 109/L
  • Hemoglobin < 11 g/dL
  • Total bilirubin > 1.2 mg/dL
  • CBT > 15 min

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Archemix Corp.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

February 6, 2007

First Submitted That Met QC Criteria

February 6, 2007

First Posted (Estimate)

February 8, 2007

Study Record Updates

Last Update Posted (Estimate)

April 20, 2007

Last Update Submitted That Met QC Criteria

April 19, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1779-06-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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