Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 in Healthy Volunteers

Thrombosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00432770
• Other study ID #: 1779-06-001
• Status: Completed
• Phase: Phase 1
• First received: February 6, 2007
• Last updated: April 19, 2007
• Start date: December 2006
• Est. completion date: March 2007

Study information

• Verified date: April 2007
• Source: Archemix Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thrombosis

Intervention

Drug:
• ARC1779

Locations

Country	Name	City	State
United States	Bioanalytical Systems, Inc	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Archemix Corp.

Country where clinical trial is conducted

United States,