Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 in Healthy Volunteers

Completed · Phase 1

Conditions studied: Thrombosis

In brief

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.

Key facts

Study ID

NCT00432770

Run by

Archemix Corp.

People needed

42

Starts

2006-12-01

Expected to finish

2007-03-01

Last updated by the study team

2007-04-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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