Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Archemix Corp.
ClinicalTrials.gov Identifier:
NCT00432770
First received: February 6, 2007
Last updated: April 19, 2007
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
Thrombosis
Drug: ARC1779
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Archemix Corp.:

Estimated Enrollment: 42
Study Start Date: December 2006
Study Completion Date: March 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432770

Locations
United States, Maryland
Bioanalytical Systems, Inc
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Archemix Corp.
  More Information

No publications provided by Archemix Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00432770     History of Changes
Other Study ID Numbers: 1779-06-001
Study First Received: February 6, 2007
Last Updated: April 19, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 26, 2014